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Comparison Of 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00413660
Collaborator
(none)
509
Enrollment
82
Locations
7
Arms
19
Duration (Months)
6.2
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effectiveness and safety, over 6 months, of 6 dose regimens of CP-690,550, combined with methotrexate, for the treatment of adults with active rheumatoid arthritis.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
509 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2B, Randomized, Double Blind, Placebo-Controlled, Multicenter Study To Compare 6 Dose Regimens Of CP-690,550 Vs. Placebo, Each Combined With Methotrexate, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate Alone
Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Aug 1, 2008
Actual Study Completion Date :
Aug 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: CP 690,550 1 mg BID

Drug: CP-690,550
4 blinded tablets administered BID
Experimental: CP 690,550 10 mg BID

Drug: CP-690,550
4 blinded tablets administered BID
Experimental: CP 690,550 15 mg

Drug: CP-690,550
4 blinded tablets administered BID
Experimental: CP 690,550 3 mg BID

Drug: CP-690,550
4 blinded tablets administered BID
Experimental: CP 690,550 5 mg BID

Drug: CP-690,550
4 blinded tablets administered BID
Experimental: CP-690,550 20 mg QD

Drug: CP-690,550
Oral tablets
Placebo Comparator: Placebo

Dummy tablets

Other: placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 [Week 12]

    ACR20 response: >= 20% improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).

Secondary Outcome Measures

  1. Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response [Week 2, 4, 6, 8, 16, 20, 24/Early Termination (ET)]

    ACR20 response: >= 20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.

  2. Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response [Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

    ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.

  3. Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response [Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

    ACR70 response: >= 70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.

  4. Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve [Baseline up to Week 2, 4, 6, 8, 12]

    ACR-n: calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The area under the curve (AUC) for ACR-n is the measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.

  5. Tender Joints Count (TJC) [Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

    Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.

  6. Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

    Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement.

  7. Swollen Joints Count (SJC) [Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

    Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.

  8. Change From Baseline in Swollen Joints Count (SJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

    Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement.

  9. Patient Assessment of Arthritis Pain [Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

    Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.

  10. Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

    Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.

  11. Patient Global Assessment (PtGA) of Arthritis [Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

    Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.

  12. Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

    Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.

  13. Physician Global Assessment of Arthritis [Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

    Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

  14. Change From Baseline in Physician Global Assessment of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

    Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

  15. Health Assessment Questionnaire-Disability Index (HAQ-DI) [Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

    HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

  16. Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

    HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Change = scores at observation minus score at Baseline, and total possible score ranged from -3 to 3. A negative value in change from baseline indicates an improvement.

  17. C-Reactive Protein (CRP) [Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

    The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per deciliter (mg/dL) to 10 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

  18. Change From Baseline in C-Reactive Protein (CRP) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

    The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. Normal range of CRP is 0 mg/dL to 10 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

  19. Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) [Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

    DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and more than (>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) less than (<) 2.6 = remission.

  20. Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

    DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.

  21. Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) [Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

    Disease improvement was classified as good, moderate, and none based on improvement in DAS 28-3 (CRP) from baseline and present DAS 28-3 (CRP) score. Good: an improvement from baseline of >1.2 and a present score of <=3.2; none: an improvement of <=0.6 or >0.6 to <=1.2 with a present score of >5.1; remaining participants were classified as having moderate (Mod) improvement. Scores of good and moderate were considered to have therapeutic response.

  22. Percentage of Participants With Disease Remission Based on DAS28-3 (CRP) [Week 2, 4, 6, 8, 12, 16, 20, 24/ET]

    DAS28-3 (CRP) defined remission was classified as a score of <2.6.

  23. 36-Item Short-Form Health Survey (SF-36) [Baseline, Week 12, 24/ET]

    SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

  24. Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET [Baseline, Week 12, 24/ET]

    SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

  25. Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility Score [Baseline, Week 12, 24/ET]

    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  26. Change From Baseline in Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility at Week 12 and 24/ET [Baseline, Week 12, 24/ET]

    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  27. Medical Outcome Study- Sleep Scale (MOS-SS) [Baseline, Week 2, 12, 24/ET]

    Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0)and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.

  28. Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET [Baseline, Week 2, 12, 24/ET]

    Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range: 0-100); sleep quantity (Qua) (range: 0-24), and optimal (Opt) sleep (yes: 1, no: 0) and 9 item index measures of sleep disturbance were constructed to provide 2 composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range*100); total score range: 0 to 100; higher score = greater intensity of attribute.

  29. Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale [Baseline, Week 2, 12, 24/ET]

    FACIT-Fatigue scale (FS) is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.

  30. Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET [Baseline, Week 2, 12, 24/ET]

    FACIT-FS is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Active rheumatoid arthritis

  • Inadequate response to stably dosed methotrexate

Exclusion Criteria:
  • Current therapy with any DMARD or biologic other than methotrexate

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Gilbert Arizona United States 85234
2 Pfizer Investigational Site Hot Springs Arkansas United States 71913
3 Pfizer Investigational Site Upland California United States 91786
4 Pfizer Investigational Site Denver Colorado United States 80204
5 Pfizer Investigational Site Newark Delaware United States 19713
6 Pfizer Investigational Site Debary Florida United States 32713
7 Pfizer Investigational Site Lake Mary Florida United States 32746
8 Pfizer Investigational Site Ocala Florida United States 34474
9 Pfizer Investigational Site Orlando Florida United States 32804
10 Pfizer Investigational Site Tampa Florida United States 33614
11 Pfizer Investigational Site Zephyrhills Florida United States 33540
12 Pfizer Investigational Site Rockford Illinois United States 61103-3692
13 Pfizer Investigational Site Rockford Illinois United States 61107
14 Pfizer Investigational Site Dubuque Iowa United States 52002
15 Pfizer Investigational Site Frederick Maryland United States 21702
16 Pfizer Investigational Site Boston Massachusetts United States 02115
17 Pfizer Investigational Site Albany New York United States 12206-1043
18 Pfizer Investigational Site Binghamton New York United States 13905
19 Pfizer Investigational Site Charlotte North Carolina United States 28210
20 Pfizer Investigational Site Raleigh North Carolina United States 27609
21 Pfizer Investigational Site Dayton Ohio United States 45402
22 Pfizer Investigational Site Philladelphia Pennsylvania United States 19118
23 Pfizer Investigational Site West Reading Pennsylvania United States 19611-1124
24 Pfizer Investigational Site Greenville South Carolina United States 29601
25 Pfizer Investigational Site Austin Texas United States 78705
26 Pfizer Investigational Site Dallas Texas United States 75231
27 Pfizer Investigational Site Dallas Texas United States 75235
28 Pfizer Investigational Site Mesquite Texas United States 75150
29 Pfizer Investigational Site Seattle Washington United States 98104
30 Pfizer Investigational Site Seattle Washington United States 98122
31 Pfizer Investigational Site Tacoma Washington United States 98405-2308
32 Pfizer Investigational Site Tacoma Washington United States 98405
33 Pfizer Investigational Site Onalaska Wisconsin United States 54650
34 Pfizer Investigational Site Capital Federal Buenos Aires Argentina (C1117ABH)
35 Pfizer Investigational Site Buenos Aires Argentina C1013AAR
36 Pfizer Investigational Site Buenos Aires Argentina C1034ACO
37 Pfizer Investigational Site Buenos Aires Argentina C1426ABP
38 Pfizer Investigational Site Goiania GO Brazil 74110-120
39 Pfizer Investigational Site Goiânia GO Brazil 74043-110
40 Pfizer Investigational Site Curitiba PR Brazil 80060-240
41 Pfizer Investigational Site Curitiba PR Brazil 80060-900
42 Pfizer Investigational Site Sao Paulo SP Brazil 04230-000
43 Pfizer Investigational Site São Paulo SP Brazil 05403-010
44 Pfizer Investigational Site Sofia 1606 Bulgaria
45 Pfizer Investigational Site Sofia Bulgaria 1612
46 Pfizer Investigational Site Sofia Bulgaria 1709
47 Pfizer Investigational Site Providencia RM Chile
48 Pfizer Investigational Site Santiago RM Chile 7500922
49 Pfizer Investigational Site Viña Del Mar V Region Chile 2570017
50 Pfizer Investigational Site Santiago Chile
51 Pfizer Investigational Site Brno Czech Republic 656 91
52 Pfizer Investigational Site Ceske Budejovice Czech Republic 370 01
53 Pfizer Investigational Site Praha 11 - Chodov Czech Republic 148 00
54 Pfizer Investigational Site Praha 2 Czech Republic 128 50
55 Pfizer Investigational Site Praha 4 Czech Republic 140 59
56 Pfizer Investigational Site Zlin Czech Republic 760 01
57 Pfizer Investigational Site Budapest Hungary H-1036
58 Pfizer Investigational Site Komarom Hungary H-2921
59 Pfizer Investigational Site Szolnok Hungary H-5000
60 Pfizer Investigational Site Veszprem Hungary H-8200
61 Pfizer Investigational Site Mexico DF Mexico 14000
62 Pfizer Investigational Site Morelia Michoacan Mexico 58070
63 Pfizer Investigational Site Bialystok Poland 15-461
64 Pfizer Investigational Site Bialystok Poland 15-950
65 Pfizer Investigational Site Grudziadz Poland 86-300
66 Pfizer Investigational Site Poznan Poland 60-773
67 Pfizer Investigational Site Sopot Poland 81-759
68 Pfizer Investigational Site Warszawa Poland 02-256
69 Pfizer Investigational Site Wroclaw Poland 50-088
70 Pfizer Investigational Site Bratislava Slovakia 81109
71 Pfizer Investigational Site Piestany Slovakia 921 01
72 Pfizer Investigational Site Zilina Slovakia 012 07
73 Pfizer Investigational Site Santiago de Compostela A Coruña Spain 15706
74 Pfizer Investigational Site Guadalajara Spain 19002
75 Pfizer Investigational Site Madrid Spain 28046
76 Pfizer Investigational Site Sevilla Spain 41014
77 Pfizer Investigational Site Jonkoping Sweden 551 85
78 Pfizer Investigational Site Umea Sweden 901 85
79 Pfizer Investigational Site Ankara Turkey 06100
80 Pfizer Investigational Site Istanbul Turkey 34098
81 Pfizer Investigational Site Izmir Turkey 35100
82 Pfizer Investigational Site Izmir Turkey 35340

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00413660
Other Study ID Numbers:
  • A3921025
First Posted:
Dec 20, 2006
Last Update Posted:
Jan 18, 2013
Last Verified:
Jan 1, 2013
Keywords provided by Pfizer
DMARD therapy
Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Tofacitinib

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg Placebo CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Period Title: Up To Week 12
STARTED 71 68 71 75 75 80 69 0 0 0 0
Treated 70 68 71 74 75 80 69 0 0 0 0
COMPLETED 64 61 64 67 66 70 58 0 0 0 0
NOT COMPLETED 7 7 7 8 9 10 11 0 0 0 0
Period Title: Up To Week 12
STARTED 43 48 64 67 66 57 40 21 13 13 18
COMPLETED 40 44 56 66 60 54 37 21 13 12 17
NOT COMPLETED 3 4 8 1 6 3 3 0 0 1 1

Baseline Characteristics

Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg Placebo Total
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Total of all reporting groups
Overall Participants 70 68 71 74 75 80 69 507
Age, Customized (participants) [Number]
18 to 44 Years
15
21.4%
23
33.8%
19
26.8%
9
12.2%
14
18.7%
15
18.8%
17
24.6%
112
22.1%
45 to 64 Years
47
67.1%
31
45.6%
42
59.2%
49
66.2%
49
65.3%
49
61.3%
40
58%
307
60.6%
Greater Than or Equal to (>=) 65 Years
8
11.4%
14
20.6%
10
14.1%
16
21.6%
12
16%
16
20%
12
17.4%
88
17.4%
Sex: Female, Male (Count of Participants)
Female
57
81.4%
52
76.5%
57
80.3%
55
74.3%
66
88%
63
78.8%
56
81.2%
406
80.1%
Male
13
18.6%
16
23.5%
14
19.7%
19
25.7%
9
12%
17
21.3%
13
18.8%
101
19.9%

Outcome Measures

1. Primary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Description ACR20 response: >= 20% improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Time Frame Week 12

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using Baseline Observation Carried Forward (BOCF).
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg Placebo
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
Measure Participants 70 68 71 74 75 80 69
Number [percentage of participants]
47.14
67.3%
55.88
82.2%
56.34
79.4%
58.11
78.5%
56.00
74.7%
56.25
70.3%
36.23
52.5%
2. Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
Description ACR20 response: >= 20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame Week 2, 4, 6, 8, 16, 20, 24/Early Termination (ET)

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using BOCF. Here "n" is number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 70 21 68 13 71 74 75 80 13 69 18
Week 2 (n=70,0,68,0,71,74,75,80,0,69,0)
21.43
30.6%
NA
NaN
36.76
51.8%
NA
NaN
30.99
41.3%
31.08
38.9%
40.00
58%
33.75
6.7%
NA
NaN
15.94
NaN
NA
NaN
Week 4 (n=70,0,68,0,71,74,75,80,0,69,0)
37.14
53.1%
NA
NaN
45.59
64.2%
NA
NaN
46.48
62%
45.95
57.4%
54.67
79.2%
51.25
10.1%
NA
NaN
24.64
NaN
NA
NaN
Week 6 (n=70,0,68,0,71,74,75,80,0,69,0)
44.29
63.3%
NA
NaN
54.41
76.6%
NA
NaN
57.75
77%
55.41
69.3%
56.00
81.2%
50.00
9.9%
NA
NaN
37.68
NaN
NA
NaN
Week 8 (n=70,0,68,0,71,74,75,80,0,69,0)
50.00
71.4%
NA
NaN
54.41
76.6%
NA
NaN
54.93
73.2%
56.76
71%
64.00
92.8%
56.25
11.1%
NA
NaN
33.33
NaN
NA
NaN
Week 16 (n=49,21,55,13,71,74,75,67,13,51,18)
63.3
90.4%
0.0
0%
60.0
84.5%
0.0
0%
53.5
71.3%
64.9
81.1%
62.7
90.9%
64.2
12.7%
0.0
NaN
43.1
NaN
0.0
NaN
Week 20 (n=49,21,55,13,71,74,75,67,13,51,18)
59.2
84.6%
0.0
0%
67.3
94.8%
0.0
0%
57.7
76.9%
62.2
77.8%
61.3
88.8%
64.2
12.7%
0.0
NaN
47.1
NaN
0.0
NaN
Week 24 (n=49,21,55,13,71,74,75,67,13,51,18)
59.2
84.6%
0.0
0%
65.5
92.3%
0.0
0%
59.2
78.9%
66.2
82.8%
65.3
94.6%
62.7
12.4%
0.0
NaN
47.1
NaN
0.0
NaN
3. Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Description ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using BOCF. Here "n" is number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 70 21 68 13 71 74 75 80 13 69 18
Week 2 (n=70,0,68,0,71,74,75,80,0,69,0)
1.43
2%
NA
NaN
5.88
8.3%
NA
NaN
5.63
7.5%
4.05
5.1%
17.33
25.1%
15.00
3%
NA
NaN
2.90
NaN
NA
NaN
Week 4 (n=70,0,68,0,71,74,75,80,0,69,0)
4.29
6.1%
NA
NaN
16.18
22.8%
NA
NaN
11.27
15%
20.27
25.3%
26.67
38.7%
25.00
4.9%
NA
NaN
2.90
NaN
NA
NaN
Week 6 (n=70,0,68,0,71,74,75,80,0,69,0)
10.00
14.3%
NA
NaN
29.41
41.4%
NA
NaN
30.99
41.3%
27.03
33.8%
32.00
46.4%
27.50
5.4%
NA
NaN
8.70
NaN
NA
NaN
Week 8 (n=70,0,68,0,71,74,75,80,0,69,0)
17.14
24.5%
NA
NaN
32.35
45.6%
NA
NaN
32.39
43.2%
28.38
35.5%
41.33
59.9%
32.50
6.4%
NA
NaN
17.39
NaN
NA
NaN
Week 12 (n=70,0,68,0,71,74,75,80,0,69,0)
22.86
32.7%
NA
NaN
29.41
41.4%
NA
NaN
36.62
48.8%
28.38
35.5%
44.00
63.8%
36.25
7.1%
NA
NaN
17.39
NaN
NA
NaN
Week 16 (n=49,21,55,13,71,74,75,67,13,51,18)
38.8
55.4%
0.0
0%
43.6
61.4%
0.0
0%
38.0
50.7%
36.5
45.6%
40.0
58%
41.8
8.2%
0.0
NaN
21.6
NaN
0.0
NaN
Week 20 (n=49,21,55,13,71,74,75,67,13,51,18)
38.8
55.4%
0.0
0%
45.5
64.1%
0.0
0%
38.0
50.7%
40.5
50.6%
48.0
69.6%
47.8
9.4%
0.0
NaN
31.4
NaN
0.0
NaN
Week 24 (n=49,21,55,13,71,74,75,67,13,51,18)
44.9
64.1%
0.0
0%
34.5
48.6%
0.0
0%
39.4
52.5%
39.2
49%
46.7
67.7%
46.3
9.1%
0.0
NaN
31.4
NaN
0.0
NaN
4. Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Description ACR70 response: >= 70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using BOCF. Here "n" is number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 70 21 68 13 71 74 75 80 13 69 18
Week 2 (n=70,0,68,0,71,74,75,80,0,69,0)
1.43
2%
NA
NaN
1.47
2.1%
NA
NaN
1.41
1.9%
1.35
1.7%
6.67
9.7%
2.50
0.5%
NA
NaN
0.00
NaN
NA
NaN
Week 4 (n=70,0,68,0,71,74,75,80,0,69,0)
2.86
4.1%
NA
NaN
7.35
10.4%
NA
NaN
0.00
0%
14.86
18.6%
13.33
19.3%
12.50
2.5%
NA
NaN
1.45
NaN
NA
NaN
Week 6 (n=70,0,68,0,71,74,75,80,0,69,0)
1.43
2%
NA
NaN
13.24
18.6%
NA
NaN
16.90
22.5%
9.46
11.8%
16.00
23.2%
12.50
2.5%
NA
NaN
4.35
NaN
NA
NaN
Week 8 (n=70,0,68,0,71,74,75,80,0,69,0)
8.57
12.2%
NA
NaN
14.71
20.7%
NA
NaN
11.27
15%
16.22
20.3%
16.00
23.2%
17.50
3.5%
NA
NaN
5.80
NaN
NA
NaN
Week 12 (n=70,0,68,0,71,74,75,80,0,69,0)
4.29
6.1%
NA
NaN
20.59
29%
NA
NaN
18.31
24.4%
12.16
15.2%
24.00
34.8%
23.75
4.7%
NA
NaN
5.80
NaN
NA
NaN
Week 16 (n=49,21,55,13,71,74,75,67,13,51,18)
16.3
23.3%
0.0
0%
21.8
30.7%
0.0
0%
18.3
24.4%
18.9
23.6%
24.0
34.8%
22.4
4.4%
0.0
NaN
9.8
NaN
0.0
NaN
Week 20 (n=49,21,55,13,71,74,75,67,13,51,18)
20.4
29.1%
0.0
0%
29.1
41%
0.0
0%
23.9
31.9%
24.3
30.4%
28.0
40.6%
28.4
5.6%
0.0
NaN
13.7
NaN
0.0
NaN
Week 24 (n=49,21,55,13,71,74,75,67,13,51,18)
28.6
40.9%
0.0
0%
23.6
33.2%
0.0
0%
21.1
28.1%
18.9
23.6%
32.0
46.4%
28.4
5.6%
0.0
NaN
9.8
NaN
0.0
NaN
5. Secondary Outcome
Title Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve
Description ACR-n: calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The area under the curve (AUC) for ACR-n is the measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.
Time Frame Baseline up to Week 2, 4, 6, 8, 12

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using Last Observation Carried Forward (LOCF).
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg Placebo
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
Measure Participants 70 68 71 74 75 80 69
Week 2
-14.07
(247.36)
22.16
(243.19)
4.47
(319.92)
-21.34
(661.05)
88.72
(287.91)
36.55
(267.26)
-113.31
(429.17)
Week 4
61.66
(622.43)
163.40
(659.05)
92.24
(919.49)
7.29
(2038.26)
341.52
(820.16)
170.23
(825.49)
-296.38
(1270.69)
Week 6
244.11
(948.25)
442.29
(1087.57)
348.96
(1446.07)
111.83
(3626.48)
716.69
(1285.36)
402.21
(1428.69)
-453.18
(2265.12)
Week 8
464.42
(1424.59)
772.65
(1594.84)
693.90
(1952.07)
239.54
(5389.58)
1154.14
(1733.13)
725.67
(1954.96)
-571.99
(3310.17)
Week 12
995.34
(2349.99)
1511.40
(2711.76)
1420.20
(3284.51)
588.45
(8969.29)
1974.18
(3231.70)
1504.58
(2979.75)
-755.22
(5107.45)
6. Secondary Outcome
Title Tender Joints Count (TJC)
Description Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.
Time Frame Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 70 21 68 13 71 74 75 80 12 69 17
Baseline (n=70,0,68,0,71,74,75,80,0,69,0)
23.64
(11.60)
NA
(NA)
22.79
(10.57)
NA
(NA)
21.46
(12.95)
24.84
(12.51)
23.68
(12.71)
23.11
(12.67)
NA
(NA)
21.59
(13.18)
NA
(NA)
Week 2 (n=68,0,68,0,68,73,73,79,0,66,0)
18.62
(12.09)
NA
(NA)
17.71
(11.87)
NA
(NA)
15.56
(10.44)
17.34
(12.13)
16.32
(13.18)
15.33
(12.59)
NA
(NA)
18.86
(13.00)
NA
(NA)
Week 4 (n=68,0,65,0,67,70,72,76,0,66,0)
15.01
(11.19)
NA
(NA)
12.80
(10.36)
NA
(NA)
13.06
(11.59)
14.01
(14.73)
13.00
(12.48)
13.75
(13.08)
NA
(NA)
16.17
(12.36)
NA
(NA)
Week 6 (n=66,0,65,0,69,71,72,74,0,62,0)
14.48
(12.18)
NA
(NA)
11.12
(9.56)
NA
(NA)
10.23
(10.44)
13.55
(14.38)
11.51
(12.67)
13.22
(13.25)
NA
(NA)
14.74
(13.86)
NA
(NA)
Week 8 (n=66,0,62,0,66,67,70,73,0,61,0)
14.24
(12.50)
NA
(NA)
10.18
(10.30)
NA
(NA)
9.82
(11.08)
12.22
(13.75)
9.49
(11.71)
11.15
(13.76)
NA
(NA)
13.57
(14.16)
NA
(NA)
Week 12 (n=64,0,59,0,64,66,66,70,0,61,0)
12.84
(12.79)
NA
(NA)
8.83
(9.61)
NA
(NA)
10.09
(11.65)
10.88
(12.79)
10.18
(12.65)
11.27
(13.68)
NA
(NA)
13.77
(14.84)
NA
(NA)
Week 16 (n=42,21,45,13,58,66,61,55,12,37,16)
8.07
(9.11)
19.33
(15.70)
6.02
(7.97)
19.15
(16.42)
8.64
(12.25)
9.77
(12.49)
8.39
(11.32)
7.07
(8.86)
26.25
(19.07)
8.51
(7.25)
15.56
(18.52)
Week 20 (n=39,21,44,13,57,66,59,55,12,37,17)
8.08
(11.06)
13.76
(12.02)
5.32
(6.35)
15.00
(11.47)
7.16
(9.91)
8.27
(11.32)
6.98
(9.96)
6.51
(10.55)
23.00
(16.59)
7.62
(7.26)
15.24
(17.68)
Week 24 (n=40,20,44,13,55,64,60,53,12,36,17)
7.45
(10.88)
14.80
(14.09)
5.52
(5.65)
13.92
(9.93)
6.85
(9.51)
8.20
(9.94)
6.37
(8.72)
5.87
(7.68)
21.67
(13.69)
5.33
(5.74)
15.88
(17.46)
7. Secondary Outcome
Title Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET
Description Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement.
Time Frame Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 68 21 68 13 68 73 73 79 12 66 17
Week 2 (n=68,0,68,0,68,73,73,79,0,66,0)
-4.68
(7.26)
NA
(NA)
-5.09
(9.91)
NA
(NA)
-6.06
(9.36)
-7.62
(8.48)
-7.68
(10.20)
-7.78
(9.67)
NA
(NA)
-2.27
(7.50)
NA
(NA)
Week 4 (n=68,0,65,0,67,70,72,76,0,66,0)
-8.28
(8.68)
NA
(NA)
-10.26
(9.63)
NA
(NA)
-8.42
(9.73)
-10.77
(10.25)
-10.90
(11.13)
-9.59
(10.42)
NA
(NA)
-5.03
(10.05)
NA
(NA)
Week 6 (n=66,0,65,0,69,71,72,74,0,62,0)
-8.86
(10.26)
NA
(NA)
-11.78
(10.82)
NA
(NA)
-11.01
(9.64)
-11.07
(9.94)
-12.14
(10.07)
-10.58
(9.60)
NA
(NA)
-6.69
(11.68)
NA
(NA)
Week 8 (n=66,0,62,0,66,67,70,73,0,61,0)
-9.08
(10.79)
NA
(NA)
-12.69
(11.57)
NA
(NA)
-11.50
(9.06)
-11.93
(10.92)
-13.76
(11.73)
-12.26
(9.96)
NA
(NA)
-7.03
(13.26)
NA
(NA)
Week 12 (n=64,0,59,0,64,66,66,70,0,61,0)
-10.67
(10.73)
NA
(NA)
-14.00
(12.56)
NA
(NA)
-10.88
(11.01)
-13.47
(9.96)
-14.24
(11.80)
-12.77
(10.92)
NA
(NA)
-6.84
(12.84)
NA
(NA)
Week 16 (n=42,21,45,13,58,66,61,55,12,37,16)
-14.05
(9.97)
-6.81
(7.90)
-17.44
(10.54)
-1.00
(14.29)
-12.93
(12.63)
-14.58
(11.19)
-15.05
(11.31)
-15.65
(9.29)
-2.33
(15.69)
-10.16
(9.92)
-8.06
(10.88)
Week 20 (n=39,21,44,13,57,66,59,55,12,37,17)
-13.64
(10.63)
-12.38
(10.61)
-18.36
(9.52)
-5.15
(11.07)
-14.58
(11.94)
-16.08
(10.43)
-16.64
(10.73)
-15.67
(9.33)
-5.58
(11.32)
-11.05
(11.86)
-8.24
(11.19)
Week 24 (n=40,21,44,13,55,64,60,53,12,36,17)
-14.53
(10.83)
-10.40
(11.27)
-18.16
(9.82)
-6.23
(10.54)
-14.93
(11.72)
-16.36
(9.39)
-17.03
(10.39)
-16.36
(10.60)
-6.92
(12.62)
-13.17
(9.90)
-7.59
(12.39)
8. Secondary Outcome
Title Swollen Joints Count (SJC)
Description Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.
Time Frame Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 70 21 68 13 71 74 75 80 12 69 17
Baseline (n=70,0,68,0,71,74,75,80,0,69,0)
16.51
(8.24)
NA
(NA)
15.68
(8.56)
NA
(NA)
14.06
(7.44)
14.74
(7.46)
15.33
(7.02)
15.21
(8.04)
NA
(NA)
15.72
(8.83)
NA
(NA)
Week 2 (n=68,0,68,0,68,73,73,79,0,66,0)
12.62
(7.81)
NA
(NA)
10.97
(9.02)
NA
(NA)
9.51
(6.30)
10.14
(7.92)
10.07
(7.29)
10.14
(6.26)
NA
(NA)
13.41
(9.47)
NA
(NA)
Week 4 (n=68,0,65,0,67,70,72,76,0,66,0)
9.85
(7.74)
NA
(NA)
8.58
(8.20)
NA
(NA)
8.01
(7.45)
7.53
(6.98)
7.85
(6.70)
8.61
(7.16)
NA
(NA)
11.11
(8.58)
NA
(NA)
Week 6 (n=66,0,65,0,69,71,72,74,0,62,0)
8.77
(6.34)
NA
(NA)
7.23
(7.28)
NA
(NA)
6.22
(6.00)
7.10
(7.62)
6.60
(6.31)
7.66
(7.43)
NA
(NA)
10.39
(9.24)
NA
(NA)
Week 8 (n=66,0,62,0,66,67,70,73,0,61,0)
8.20
(7.84)
NA
(NA)
6.63
(7.63)
NA
(NA)
5.35
(5.03)
6.78
(7.43)
6.01
(6.22)
7.22
(8.60)
NA
(NA)
8.16
(8.02)
NA
(NA)
Week 12 (n=64,0,59,0,64,66,66,70,0,61,0)
8.31
(8.41)
NA
(NA)
5.36
(6.64)
NA
(NA)
6.13
(6.82)
5.50
(5.84)
4.85
(6.04)
6.80
(8.87)
NA
(NA)
8.79
(9.10)
NA
(NA)
Week 16 (n=42,21,45,13,58,66,61,55,12,37,16)
5.83
(7.43)
8.90
(7.55)
3.49
(3.78)
10.00
(10.51)
3.84
(4.40)
4.74
(5.64)
4.26
(5.40)
3.58
(3.54)
14.50
(12.99)
5.97
(5.98)
8.63
(7.70)
Week 20 (n=39,21,44,13,57,66,59,55,12,37,17)
4.95
(7.82)
7.33
(8.75)
3.36
(5.19)
8.54
(9.85)
3.95
(5.80)
4.21
(5.59)
3.27
(4.02)
3.31
(4.19)
12.25
(8.25)
5.00
(6.65)
7.41
(9.27)
Week 24 (n=40,20,44,13,55,64,60,53,12,36,17)
4.10
(4.83)
8.65
(8.77)
3.73
(5.35)
7.00
(7.14)
3.71
(4.33)
4.41
(6.86)
3.03
(3.75)
2.89
(2.97)
11.25
(9.81)
4.11
(3.90)
7.94
(8.90)
9. Secondary Outcome
Title Change From Baseline in Swollen Joints Count (SJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET
Description Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement.
Time Frame Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 68 21 68 13 68 73 73 79 12 66 17
Week 2 (n=68,0,68,0,68,73,73,79,0,66,0)
-3.43
(5.98)
NA
(NA)
-4.71
(7.40)
NA
(NA)
-4.24
(6.33)
-4.75
(5.57)
-5.45
(7.74)
-5.04
(7.45)
NA
(NA)
-2.12
(5.00)
NA
(NA)
Week 4 (n=68,0,65,0,67,70,72,76,0,66,0)
-6.19
(6.50)
NA
(NA)
-7.25
(8.80)
NA
(NA)
-5.97
(5.44)
-7.34
(6.27)
-7.64
(6.77)
-6.74
(8.13)
NA
(NA)
-4.56
(5.61)
NA
(NA)
Week 6 (n=66,0,65,0,69,71,72,74,0,62,0)
-7.41
(6.58)
NA
(NA)
-8.42
(9.28)
NA
(NA)
-7.68
(6.30)
-7.68
(7.35)
-8.68
(6.73)
-7.97
(7.54)
NA
(NA)
-5.48
(6.91)
NA
(NA)
Week 8 (n=66,0,62,0,66,67,70,73,0,61,0)
-7.80
(8.13)
NA
(NA)
-9.03
(9.79)
NA
(NA)
-8.74
(6.94)
-8.06
(7.40)
-9.31
(7.51)
-8.26
(8.30)
NA
(NA)
-7.15
(6.82)
NA
(NA)
Week 12 (n=64,0,59,0,64,66,66,70,0,61,0)
-7.61
(9.15)
NA
(NA)
-10.47
(9.71)
NA
(NA)
-8.13
(8.00)
-9.20
(7.16)
-10.68
(7.37)
-8.84
(8.48)
NA
(NA)
-6.52
(8.28)
NA
(NA)
Week 16 (n=42,21,45,13,58,66,61,55,12,37,16)
-10.67
(8.78)
-5.95
(6.99)
-13.00
(8.90)
-2.46
(5.77)
-10.60
(7.43)
-9.95
(6.97)
-10.66
(6.75)
-10.65
(7.09)
-5.83
(13.62)
-8.65
(6.58)
-6.88
(6.51)
Week 20 (n=39,21,44,13,57,66,59,55,12,37,17)
-10.95
(8.32)
-7.52
(8.20)
-13.36
(8.25)
-3.92
(5.72)
-10.39
(6.98)
-10.48
(7.21)
-11.61
(6.35)
-11.00
(6.99)
-8.08
(9.89)
-9.62
(7.31)
-7.88
(9.21)
Week 24 (n=40,20,44,13,55,64,60,53,12,36,17)
-12.15
(7.83)
-6.60
(7.50)
-13.00
(8.52)
-5.46
(6.77)
-10.25
(6.70)
-10.48
(6.33)
-11.70
(6.38)
-11.57
(7.50)
-9.08
(11.99)
-10.28
(7.46)
-7.35
(6.47)
10. Secondary Outcome
Title Patient Assessment of Arthritis Pain
Description Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Time Frame Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 70 21 67 13 71 74 75 80 12 69 17
Baseline (n=70,0,66,0,71,74,75,80,0,69,0)
59.96
(25.67)
NA
(NA)
55.05
(24.81)
NA
(NA)
54.87
(26.68)
56.66
(25.42)
55.83
(22.85)
59.61
(23.61)
NA
(NA)
51.19
(27.72)
NA
(NA)
Week 2 (n=68,0,67,0,68,73,73,79,0,66,0)
49.53
(24.99)
NA
(NA)
43.33
(23.26)
NA
(NA)
44.35
(24.31)
41.26
(22.18)
37.82
(22.17)
40.57
(27.24)
NA
(NA)
46.91
(25.39)
NA
(NA)
Week 4 (n=68,0,65,0,67,70,72,76,0,66,0)
45.57
(24.99)
NA
(NA)
37.83
(22.77)
NA
(NA)
40.03
(24.25)
39.34
(25.09)
35.81
(23.88)
34.39
(24.29)
NA
(NA)
42.02
(24.40)
NA
(NA)
Week 6 (n=66,0,65,0,69,71,72,74,0,61,0)
38.74
(24.31)
NA
(NA)
33.75
(25.06)
NA
(NA)
33.33
(24.18)
34.38
(23.15)
32.97
(23.50)
33.65
(25.47)
NA
(NA)
42.21
(27.12)
NA
(NA)
Week 8 (n=66,0,62,0,66,67,70,73,0,61,0)
38.97
(23.33)
NA
(NA)
28.81
(23.86)
NA
(NA)
36.55
(25.00)
34.60
(24.04)
30.26
(22.20)
31.16
(24.86)
NA
(NA)
41.34
(26.45)
NA
(NA)
Week 12 (n=64,0,59,0,64,65,66,70,0,61,0)
35.92
(22.49)
NA
(NA)
30.90
(24.44)
NA
(NA)
28.88
(22.80)
33.78
(25.50)
31.48
(24.86)
31.09
(26.57)
NA
(NA)
41.02
(26.13)
NA
(NA)
Week 16 (n=42,21,45,13,58,66,61,54,12,37,16)
27.83
(18.65)
40.38
(21.81)
29.67
(24.13)
39.31
(24.13)
28.98
(22.15)
30.33
(22.04)
27.07
(20.76)
24.56
(23.46)
51.25
(21.95)
30.08
(22.81)
38.38
(24.52)
Week 20 (n=39,21,43,13,57,65,59,55,12,37,17)
29.28
(22.75)
35.71
(22.42)
26.63
(23.48)
42.31
(28.61)
25.91
(23.10)
33.66
(24.02)
24.69
(20.98)
24.58
(26.24)
43.92
(27.07)
25.08
(21.19)
33.00
(27.70)
Week 24 (n=40,20,44,13,55,63,60,53,12,36,17)
25.53
(21.05)
38.15
(26.27)
25.98
(20.61)
35.62
(28.27)
24.45
(20.24)
28.65
(21.11)
24.47
(22.23)
19.92
(18.27)
35.33
(27.17)
27.14
(21.17)
33.65
(26.15)
11. Secondary Outcome
Title Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET
Description Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
Time Frame Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 68 21 65 13 68 73 73 79 12 66 17
Week 2 (n=65,0,68,0,68,73,73,79,0,66,0)
-9.49
(24.31)
NA
(NA)
-11.00
(20.82)
NA
(NA)
-10.76
(26.22)
-15.30
(25.46)
-17.67
(24.58)
-18.84
(25.59)
NA
(NA)
-4.55
(25.28)
NA
(NA)
Week 4 (n=68,0,63,0,67,70,72,76,0,66,0)
-13.44
(26.39)
NA
(NA)
-17.11
(23.98)
NA
(NA)
-14.76
(24.06)
-17.80
(30.25)
-20.39
(28.95)
-24.74
(26.39)
NA
(NA)
-9.26
(28.24)
NA
(NA)
Week 6 (n=66,0,63,0,69,71,72,74,0,61,0)
-19.56
(31.29)
NA
(NA)
-22.71
(28.84)
NA
(NA)
-21.07
(29.07)
-22.94
(29.71)
-22.61
(28.87)
-26.97
(26.15)
NA
(NA)
-8.61
(29.03)
NA
(NA)
Week 8 (n=66,0,60,0,66,67,70,73,0,61,0)
-19.91
(26.68)
NA
(NA)
-26.23
(29.28)
NA
(NA)
-18.11
(29.71)
-21.84
(30.42)
-24.66
(30.16)
-29.08
(27.13)
NA
(NA)
-9.97
(28.48)
NA
(NA)
Week 12 (n=64,0,57,0,64,65,66,70,0,61,0)
-23.16
(28.49)
NA
(NA)
-24.39
(30.89)
NA
(NA)
-25.75
(29.47)
-24.02
(27.96)
-23.95
(29.90)
-29.67
(28.25)
NA
(NA)
-10.30
(30.14)
NA
(NA)
Week 16 (n=42,21,45,13,58,66,61,54,12,37,16)
-34.02
(31.75)
-13.48
(25.66)
-27.19
(24.93)
-15.15
(21.97)
-26.50
(28.81)
-26.64
(25.04)
-27.97
(29.32)
-32.09
(24.84)
-19.00
(29.73)
-17.22
(35.13)
-18.19
(21.36)
Week 20 (n=39,21,41,13,57,65,59,55,12,37,17)
-31.54
(36.96)
-18.14
(25.06)
-32.37
(26.83)
-12.15
(25.36)
-29.54
(30.99)
-22.78
(30.27)
-30.97
(31.28)
-32.95
(27.48)
-26.33
(33.15)
-22.22
(30.68)
-21.82
(21.49)
Week 24 (n=40,20,42,13,55,63,60,53,12,36,17)
-36.08
(32.62)
-15.40
(24.78)
-33.19
(25.68)
-18.85
(24.73)
-29.89
(30.87)
-28.51
(28.01)
-31.00
(31.88)
-36.98
(27.86)
-34.92
(31.74)
-21.08
(32.99)
-21.18
(26.30)
12. Secondary Outcome
Title Patient Global Assessment (PtGA) of Arthritis
Description Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.
Time Frame Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 70 21 68 13 71 74 75 79 12 69 17
Baseline (n=70,0,68,0,71,74,75,79,0,69,0)
62.47
(24.77)
NA
(NA)
58.91
(22.94)
NA
(NA)
54.62
(23.71)
58.35
(23.14)
56.09
(21.42)
57.24
(25.64)
NA
(NA)
51.88
(26.44)
NA
(NA)
Week 2 (n=68,0,68,0,68,73,73,79,0,66,0)
53.19
(22.93)
NA
(NA)
41.96
(23.12)
NA
(NA)
42.56
(22.89)
42.32
(21.98)
35.73
(21.46)
41.80
(26.25)
NA
(NA)
46.33
(25.02)
NA
(NA)
Week 4 (n=68,0,65,0,67,70,72,76,0,66,0)
47.87
(23.21)
NA
(NA)
39.78
(22.47)
NA
(NA)
38.94
(22.27)
38.53
(24.49)
34.76
(21.33)
37.47
(25.17)
NA
(NA)
41.21
(24.46)
NA
(NA)
Week 6 (n=66,0,65,0,69,71,72,74,0,61,0)
42.30
(22.34)
NA
(NA)
36.08
(23.56)
NA
(NA)
33.01
(24.06)
35.41
(22.68)
30.56
(21.87)
34.86
(25.24)
NA
(NA)
43.02
(25.14)
NA
(NA)
Week 8 (n=66,0,62,0,66,67,70,73,0,61,0)
41.06
(21.76)
NA
(NA)
30.11
(22.38)
NA
(NA)
36.50
(25.29)
36.09
(24.38)
30.61
(21.60)
31.85
(25.35)
NA
(NA)
40.64
(25.32)
NA
(NA)
Week 12 (n=64,0,59,0,64,65,66,70,0,60,0)
38.78
(22.91)
NA
(NA)
34.42
(25.15)
NA
(NA)
29.66
(21.69)
35.05
(24.65)
32.53
(24.48)
30.76
(25.59)
NA
(NA)
39.85
(25.75)
NA
(NA)
Week 16 (n=42,21,45,13,58,66,61,54,12,37,16)
30.76
(20.40)
38.29
(19.76)
29.84
(24.12)
39.31
(27.48)
30.62
(22.56)
30.98
(22.06)
26.59
(20.19)
24.76
(22.53)
50.67
(23.10)
28.46
(22.69)
37.63
(23.11)
Week 20 (n=39,21,43,13,57,66,59,55,12,37,17)
29.85
(22.86)
37.95
(23.62)
28.16
(22.36)
42.08
(27.48)
26.07
(22.75)
35.00
(23.51)
24.90
(20.57)
25.56
(23.20)
44.42
(27.38)
26.22
(21.09)
36.94
(27.13)
Week 24 (n=40,20,44,13,55,64,60,53,12,36,17)
28.23
(21.42)
38.55
(27.08)
25.93
(22.22)
38.23
(27.28)
23.64
(21.82)
29.66
(21.58)
25.07
(23.20)
21.85
(18.07)
34.83
(27.04)
28.25
(21.49)
34.59
(27.87)
13. Secondary Outcome
Title Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET
Description Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.
Time Frame Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 68 21 68 13 68 73 73 78 12 66 17
Week 2 (n=68,0,68,0,68,73,73,78,0,66,0)
-8.57
(26.12)
NA
(NA)
-16.96
(20.11)
NA
(NA)
-12.37
(21.83)
-16.74
(24.15)
-20.25
(26.92)
-15.38
(30.86)
NA
(NA)
-5.82
(24.96)
NA
(NA)
Week 4 (n=68,0,65,0,67,70,72,75,0,66,0)
-13.90
(25.53)
NA
(NA)
-19.40
(25.40)
NA
(NA)
-15.70
(22.92)
-20.76
(26.76)
-21.82
(28.55)
-19.04
(29.28)
NA
(NA)
-10.65
(27.81)
NA
(NA)
Week 6 (n=66,0,65,0,69,71,72,73,0,61,0)
-18.71
(29.02)
NA
(NA)
-22.02
(25.83)
NA
(NA)
-20.81
(24.06)
-24.03
(23.89)
-25.26
(30.85)
-22.99
(29.63)
NA
(NA)
-9.46
(23.90)
NA
(NA)
Week 8 (n=66,0,62,0,66,67,70,72,0,61,0)
-20.35
(27.84)
NA
(NA)
-27.48
(26.13)
NA
(NA)
-17.44
(28.12)
-22.58
(25.37)
-24.81
(31.07)
-25.92
(30.55)
NA
(NA)
-11.48
(25.89)
NA
(NA)
Week 12 (n=64,0,59,0,64,65,66,69,0,60,0)
-22.78
(28.81)
NA
(NA)
-23.95
(29.82)
NA
(NA)
-24.30
(24.57)
-24.77
(26.21)
-23.08
(30.87)
-28.09
(30.23)
NA
(NA)
-12.75
(28.20)
NA
(NA)
Week 16 (n=42,21,45,13,58,66,61,53,12,37,16)
-33.60
(31.45)
-15.86
(22.28)
-28.00
(28.15)
-22.00
(26.01)
-24.05
(28.00)
-27.97
(24.02)
-28.90
(29.36)
-29.68
(31.20)
-13.67
(35.93)
-20.97
(31.57)
-14.81
(17.72)
Week 20 (n=39,21,43,13,57,66,59,54,12,36,17)
-34.56
(31.99)
-16.19
(24.18)
-30.93
(25.67)
-19.23
(28.78)
-28.33
(26.93)
-23.95
(27.82)
-31.12
(32.09)
-30.67
(31.38)
-19.92
(34.52)
-23.22
(27.31)
-13.53
(22.22)
Week 24 (n=40,20,44,13,55,64,60,53,12,36,17)
-36.68
(29.89)
-15.30
(32.99)
-32.11
(25.76)
-23.08
(31.06)
-29.84
(27.59)
-28.61
(25.31)
-30.83
(32.96)
-33.04
(32.02)
-29.50
(32.33)
-21.92
(27.51)
-15.88
(25.95)
14. Secondary Outcome
Title Physician Global Assessment of Arthritis
Description Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Time Frame Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 70 21 68 13 71 74 75 80 12 69 17
Baseline (n=70,0,68,0,71,74,75,80,0,69,0)
62.66
(16.00)
NA
(NA)
57.50
(18.47)
NA
(NA)
56.51
(19.00)
60.77
(16.75)
60.51
(14.26)
58.75
(17.90)
NA
(NA)
58.30
(15.25)
NA
(NA)
Week 2 (n=67,0,68,0,68,73,73,79,0,66,0)
49.49
(21.64)
NA
(NA)
41.07
(19.88)
NA
(NA)
42.29
(20.12)
42.85
(19.42)
35.99
(15.97)
41.92
(22.30)
NA
(NA)
49.05
(18.00)
NA
(NA)
Week 4 (n=68,0,65,0,67,70,72,75,0,66,0)
41.69
(21.31)
NA
(NA)
36.92
(21.20)
NA
(NA)
34.73
(17.40)
33.56
(19.77)
33.35
(19.24)
32.96
(22.38)
NA
(NA)
40.23
(19.43)
NA
(NA)
Week 6 (n=66,0,65,0,69,71,72,74,0,62,0)
37.38
(17.11)
NA
(NA)
31.51
(21.25)
NA
(NA)
27.78
(18.40)
30.82
(19.95)
27.08
(17.28)
32.65
(23.41)
NA
(NA)
37.85
(21.03)
NA
(NA)
Week 8 (n=66,0,62,0,66,67,70,73,0,61,0)
35.71
(21.03)
NA
(NA)
26.60
(20.34)
NA
(NA)
27.26
(19.97)
28.01
(19.90)
23.06
(17.18)
27.70
(21.09)
NA
(NA)
34.66
(21.39)
NA
(NA)
Week 12 (n=63,0,59,0,64,66,65,70,0,61,0)
33.65
(20.06)
NA
(NA)
26.17
(21.33)
NA
(NA)
24.77
(18.80)
26.47
(19.69)
23.28
(17.89)
28.93
(23.44)
NA
(NA)
35.70
(24.86)
NA
(NA)
Week 16 (n=42,21,44,13,58,66,61,55,12,37,16)
23.95
(16.25)
44.19
(24.68)
19.77
(19.74)
33.31
(22.97)
23.67
(21.04)
23.00
(18.60)
19.31
(15.80)
18.60
(15.00)
48.42
(30.00)
26.22
(18.43)
27.44
(16.36)
Week 20 (n=39,21,44,13,57,66,59,55,12,37,17)
20.44
(18.10)
34.29
(16.64)
20.91
(18.21)
32.92
(25.15)
20.65
(18.68)
24.05
(18.32)
16.19
(12.41)
18.84
(18.42)
44.67
(25.31)
21.95
(18.03)
33.94
(22.43)
Week 24 (n=40,19,43,13,55,64,60,53,11,36,17)
18.90
(16.51)
36.53
(21.17)
20.26
(18.12)
32.54
(24.26)
16.91
(14.67)
21.25
(17.79)
14.68
(13.07)
14.49
(11.75)
41.00
(31.58)
20.67
(15.81)
32.18
(19.03)
15. Secondary Outcome
Title Change From Baseline in Physician Global Assessment of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET
Description Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Time Frame Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 67 21 68 13 68 73 73 79 12 68 17
Week 2 (n=67,0,68,0,68,73,73,79,0,66,0)
-12.88
(17.84)
NA
(NA)
-16.43
(19.20)
NA
(NA)
-14.60
(24.01)
-17.88
(17.66)
-24.30
(18.32)
-16.61
(19.17)
NA
(NA)
-8.82
(13.20)
NA
(NA)
Week 4 (n=68,0,65,0,67,70,72,75,0,66,0)
-20.66
(19.47)
NA
(NA)
-20.80
(22.47)
NA
(NA)
-22.00
(20.79)
-27.67
(20.61)
-27.43
(21.04)
-25.31
(22.01)
NA
(NA)
-17.79
(18.95)
NA
(NA)
Week 6 (n=66,0,65,0,69,71,72,74,0,62,0)
-25.02
(20.89)
NA
(NA)
-26.34
(24.05)
NA
(NA)
-28.80
(20.44)
-30.39
(20.61)
-33.26
(19.40)
-25.93
(23.04)
NA
(NA)
-20.15
(22.19)
NA
(NA)
Week 8 (n=66,0,62,0,66,67,70,73,0,61,0)
-26.50
(22.83)
NA
(NA)
-30.92
(22.85)
NA
(NA)
-29.67
(24.30)
-33.63
(21.96)
-37.26
(19.37)
-30.66
(21.10)
NA
(NA)
-22.82
(22.89)
NA
(NA)
Week 12 (n=63,0,59,0,64,66,66,70,0,61,0)
-28.76
(23.50)
NA
(NA)
-31.69
(24.30)
NA
(NA)
-31.58
(23.09)
-34.98
(20.53)
-36.80
(20.78)
-30.27
(22.44)
NA
(NA)
-21.77
(24.51)
NA
(NA)
Week 16 (n=42,21,44,13,58,66,61,55,12,37,16)
-39.33
(19.85)
-16.95
(26.42)
-39.23
(23.11)
-23.85
(19.42)
-33.47
(26.06)
-38.45
(20.53)
-39.70
(20.34)
-38.65
(17.68)
-19.08
(29.20)
-29.89
(22.16)
-32.56
(15.65)
Week 20 (n=39,21,44,13,57,66,59,55,12,37,17)
-42.21
(23.73)
-26.86
(23.81)
-38.70
(20.41)
-24.23
(22.29)
-36.81
(24.26)
-37.41
(18.99)
-43.42
(16.85)
-38.16
(19.33)
-22.83
(26.51)
-34.16
(23.25)
-26.29
(24.43)
Week 24 (n=40,19,43,13,55,64,60,53,11,36,17)
-44.15
(22.39)
-24.11
(24.91)
-39.98
(21.13)
-24.62
(19.99)
-39.51
(22.83)
-40.61
(20.10)
-44.65
(16.76)
-41.91
(17.09)
-28.64
(31.29)
-35.06
(21.26)
-28.06
(20.84)
16. Secondary Outcome
Title Health Assessment Questionnaire-Disability Index (HAQ-DI)
Description HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time Frame Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 70 21 66 13 71 74 75 80 12 69 17
Baseline (n=70,0,66,0,71,74,75,80,0,69,0)
1.58
(0.57)
NA
(NA)
1.36
(0.75)
NA
(NA)
1.44
(0.64)
1.33
(0.60)
1.41
(0.64)
1.46
(0.58)
NA
(NA)
1.20
(0.73)
NA
(NA)
Week 2 (n=68,0,68,0,68,73,73,79,0,66,0)
1.41
(0.61)
NA
(NA)
1.14
(0.75)
NA
(NA)
1.20
(0.58)
1.16
(0.61)
1.15
(0.67)
1.23
(0.63)
NA
(NA)
1.15
(0.64)
NA
(NA)
Week 4 (n=68,0,65,0,67,70,72,75,0,66,0)
1.32
(0.61)
NA
(NA)
1.03
(0.69)
NA
(NA)
1.13
(0.65)
1.08
(0.64)
1.12
(0.69)
1.14
(0.65)
NA
(NA)
1.14
(0.66)
NA
(NA)
Week 6 (n=66,0,64,0,69,71,72,74,0,61,0)
1.23
(0.57)
NA
(NA)
0.96
(0.69)
NA
(NA)
1.03
(0.61)
1.02
(0.65)
1.05
(0.69)
1.05
(0.65)
NA
(NA)
1.07
(0.70)
NA
(NA)
Week 8 (n=66,0,62,0,66,67,70,71,0,61,0)
1.22
(0.59)
NA
(NA)
0.93
(0.68)
NA
(NA)
1.06
(0.66)
0.89
(0.67)
0.98
(0.68)
0.98
(0.72)
NA
(NA)
1.05
(0.71)
NA
(NA)
Week 12 (n=64,0,59,0,64,65,66,68,0,61,0)
1.19
(0.63)
NA
(NA)
0.92
(0.75)
NA
(NA)
0.94
(0.65)
0.95
(0.68)
0.96
(0.69)
0.90
(0.67)
NA
(NA)
1.08
(0.74)
NA
(NA)
Week 16 (n=42,21,45,13,58,66,61,55,12,37,16)
1.05
(0.59)
1.42
(0.64)
0.82
(0.72)
1.18
(0.77)
0.92
(0.60)
0.91
(0.68)
0.97
(0.75)
0.81
(0.67)
1.36
(0.67)
0.80
(0.64)
1.05
(0.80)
Week 20 (n=39,21,44,13,57,66,59,55,12,37,17)
0.95
(0.58)
1.33
(0.72)
0.77
(0.68)
1.13
(0.78)
0.78
(0.57)
0.84
(0.65)
0.92
(0.72)
0.75
(0.63)
1.42
(0.62)
0.73
(0.65)
0.92
(0.75)
Week 24 (n=40,20,44,13,54,63,59,53,12,36,17)
0.99
(0.57)
1.38
(0.74)
0.85
(0.68)
1.05
(0.84)
0.78
(0.62)
0.85
(0.66)
0.88
(0.69)
0.72
(0.61)
1.34
(0.78)
0.74
(0.66)
0.95
(0.68)
17. Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET
Description HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Change = scores at observation minus score at Baseline, and total possible score ranged from -3 to 3. A negative value in change from baseline indicates an improvement.
Time Frame Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 68 21 66 13 68 73 73 79 12 66 17
Week 2 (n=68,0,68,0,68,73,73,79,0,66,0)
-0.15
(0.38)
NA
(NA)
-0.23
(0.49)
NA
(NA)
-0.23
(0.41)
-0.18
(0.42)
-0.24
(0.40)
-0.23
(0.45)
NA
(NA)
-0.05
(0.36)
NA
(NA)
Week 4 (n=68,0,63,0,67,70,72,75,0,66,0)
-0.24
(0.46)
NA
(NA)
-0.36
(0.52)
NA
(NA)
-0.32
(0.51)
-0.25
(0.45)
-0.31
(0.44)
-0.34
(0.50)
NA
(NA)
-0.05
(0.46)
NA
(NA)
Week 6 (n=66,0,62,0,69,71,72,74,0,61,0)
-0.31
(0.45)
NA
(NA)
-0.39
(0.53)
NA
(NA)
-0.42
(0.54)
-0.32
(0.57)
-0.34
(0.47)
-0.42
(0.52)
NA
(NA)
-0.13
(0.59)
NA
(NA)
Week 8 (n=66,0,61,0,66,67,70,71,0,61,0)
-0.34
(0.48)
NA
(NA)
-0.41
(0.63)
NA
(NA)
-0.40
(0.58)
-0.43
(0.66)
-0.39
(0.49)
-0.50
(0.61)
NA
(NA)
-0.12
(0.55)
NA
(NA)
Week 12 (n=64,0,58,0,64,65,66,68,0,61,0)
-0.37
(0.48)
NA
(NA)
-0.48
(0.61)
NA
(NA)
-0.51
(0.61)
-0.37
(0.63)
-0.45
(0.50)
-0.58
(0.61)
NA
(NA)
-0.10
(0.57)
NA
(NA)
Week 16 (n=42,21,44,13,58,66,61,55,12,37,16)
-0.52
(0.48)
-0.16
(0.50)
-0.59
(0.64)
-0.08
(0.31)
-0.52
(0.59)
-0.41
(0.63)
-0.45
(0.60)
-0.62
(0.62)
-0.46
(0.58)
-0.30
(0.52)
-0.01
(0.29)
Week 20 (n=39,21,43,13,57,66,59,55,12,37,17)
-0.62
(0.47)
-0.24
(0.42)
-0.62
(0.68)
-0.13
(0.41)
-0.64
(0.62)
-0.49
(0.58)
-0.51
(0.59)
-0.67
(0.65)
-0.41
(0.55)
-0.38
(0.54)
-0.11
(0.30)
Week 24 (n=40,20,42,13,54,63,59,53,12,36,17)
-0.60
(0.52)
-0.21
(0.58)
-0.53
(0.65)
-0.21
(0.32)
-0.61
(0.65)
-0.47
(0.62)
-0.53
(0.60)
-0.66
(0.72)
-0.48
(0.74)
-0.37
(0.54)
-0.08
(0.29)
18. Secondary Outcome
Title C-Reactive Protein (CRP)
Description The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per deciliter (mg/dL) to 10 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time Frame Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 70 21 68 13 71 74 75 80 12 69 17
Baseline (n=70,0,68,0,71,74,75,80,0,69,0)
16.30
(18.08)
NA
(NA)
15.85
(19.34)
NA
(NA)
18.03
(24.96)
14.42
(17.81)
17.21
(16.94)
14.68
(17.19)
NA
(NA)
18.88
(19.55)
NA
(NA)
Week 2 (n=65,0,63,0,63,69,68,74,0,61,0)
14.54
(19.53)
NA
(NA)
8.20
(11.77)
NA
(NA)
6.98
(10.05)
5.24
(9.59)
4.08
(4.79)
8.35
(13.48)
NA
(NA)
18.10
(20.41)
NA
(NA)
Week 4 (n=65,0,61,0,62,64,65,70,0,61,0)
10.28
(11.83)
NA
(NA)
10.11
(15.29)
NA
(NA)
8.63
(12.54)
5.46
(9.76)
4.63
(8.68)
8.67
(13.62)
NA
(NA)
15.30
(16.85)
NA
(NA)
Week 6 (n=64,0,61,0,66,67,66,69,0,58,0)
10.55
(9.79)
NA
(NA)
8.34
(13.70)
NA
(NA)
8.26
(14.30)
5.42
(10.04)
5.41
(8.63)
10.68
(17.49)
NA
(NA)
15.18
(19.32)
NA
(NA)
Week 8 (n=63,0,59,0,62,62,67,67,0,58,0)
9.62
(11.78)
NA
(NA)
7.64
(11.54)
NA
(NA)
7.17
(11.47)
10.18
(24.04)
8.39
(11.39)
9.75
(18.92)
NA
(NA)
20.38
(30.37)
NA
(NA)
Week 12 (n=61,0,57,0,60,63,62,65,0,60,0)
8.53
(9.59)
NA
(NA)
9.54
(13.52)
NA
(NA)
6.54
(9.68)
9.11
(20.08)
5.81
(7.25)
9.53
(15.08)
NA
(NA)
19.69
(20.07)
NA
(NA)
Week 16 (n=42,21,43,13,54,64,58,55,9,37,16)
7.80
(10.30)
7.02
(8.51)
10.72
(18.93)
5.85
(5.47)
5.40
(8.06)
6.77
(10.27)
9.79
(22.24)
6.52
(11.33)
6.89
(7.06)
13.08
(11.49)
6.52
(7.30)
Week 20 (n=39,21,44,13,57,63,57,55,12,36,17)
8.96
(11.64)
8.55
(12.87)
7.71
(10.88)
11.28
(17.83)
7.93
(19.22)
5.58
(8.69)
3.46
(3.17)
4.75
(5.28)
7.89
(9.08)
16.14
(16.63)
12.10
(18.21)
Week 24 (n=39,20,43,13,53,63,56,52,12,36,17)
7.63
(10.26)
6.02
(7.31)
10.31
(17.43)
12.58
(12.19)
5.92
(14.78)
6.66
(17.03)
6.51
(11.04)
4.54
(4.69)
7.19
(8.18)
13.39
(15.05)
16.21
(26.51)
19. Secondary Outcome
Title Change From Baseline in C-Reactive Protein (CRP) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET
Description The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. Normal range of CRP is 0 mg/dL to 10 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time Frame Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 65 21 63 13 63 69 68 74 12 61 17
Week 2 (n=65,0,63,0,63,69,68,74,0,61,0)
-2.05
(18.32)
NA
(NA)
-6.93
(14.85)
NA
(NA)
-11.38
(19.27)
-9.19
(19.90)
-11.87
(15.22)
-6.56
(12.70)
NA
(NA)
0.64
(14.26)
NA
(NA)
Week 4 (n=65,0,61,0,62,64,65,70,0,61,0)
-6.07
(14.44)
NA
(NA)
-5.12
(17.24)
NA
(NA)
-8.54
(16.65)
-9.45
(16.27)
-11.70
(17.89)
-6.69
(13.99)
NA
(NA)
-1.26
(12.51)
NA
(NA)
Week 6 (n=64,0,61,0,66,67,66,69,0,58,0)
-5.92
(16.61)
NA
(NA)
-6.97
(17.77)
NA
(NA)
-9.81
(23.67)
-9.38
(16.02)
-10.73
(17.63)
-5.03
(17.94)
NA
(NA)
-0.51
(12.72)
NA
(NA)
Week 8 (n=63,0,59,0,62,62,67,67,0,58,0)
-5.94
(16.03)
NA
(NA)
-7.42
(14.21)
NA
(NA)
-11.35
(21.25)
-4.97
(24.54)
-8.67
(18.05)
-6.11
(19.97)
NA
(NA)
3.70
(25.55)
NA
(NA)
Week 12 (n=61,0,57,0,60,63,62,65,0,60,0)
-7.56
(17.07)
NA
(NA)
-6.28
(14.07)
NA
(NA)
-12.52
(23.93)
-5.96
(23.26)
-10.18
(16.26)
-5.71
(20.18)
NA
(NA)
2.07
(15.90)
NA
(NA)
Week 16 (n=42,21,43,13,54,64,58,55,9,37,16)
-6.96
(10.61)
-11.26
(21.64)
-7.04
(21.18)
-6.33
(10.48)
-11.53
(22.00)
-8.18
(18.99)
-7.01
(27.54)
-8.16
(17.01)
-7.59
(12.45)
-2.59
(13.79)
-13.44
(12.75)
Week 20 (n=39,21,44,13,57,63,57,55,12,36,17)
-6.21
(10.94)
-9.73
(22.12)
-11.31
(16.46)
-0.90
(20.08)
-7.80
(23.28)
-9.60
(19.16)
-14.21
(16.73)
-9.65
(15.32)
-10.22
(13.83)
0.11
(15.15)
-7.52
(20.34)
Week 24 (n=39,20,43,43,53,63,56,52,12,36,17)
-7.61
(11.78)
-8.07
(10.28)
-7.57
(22.26)
0.40
(16.50)
-8.18
(19.26)
-8.72
(22.73)
-10.65
(18.76)
-8.75
(15.40)
-10.92
(15.78)
-2.16
(16.06)
-3.41
(26.61)
20. Secondary Outcome
Title Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
Description DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and more than (>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) less than (<) 2.6 = remission.
Time Frame Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 70 21 68 13 71 74 75 80 12 69 17
Baseline (n=70,0,68,0,71,74,75,79,0,69,0)
5.48
(0.80)
NA
(NA)
5.31
(0.95)
NA
(NA)
5.14
(0.84)
5.28
(0.85)
5.39
(0.89)
5.34
(0.87)
NA
(NA)
5.26
(0.96)
NA
(NA)
Week 2 (n=64,0,63,0,63,69,68,74,0,61,0)
4.88
(1.04)
NA
(NA)
4.46
(1.03)
NA
(NA)
4.26
(0.90)
4.18
(1.04)
4.18
(1.16)
4.28
(1.07)
NA
(NA)
4.91
(1.07)
NA
(NA)
Week 4 (n=65,0,61,0,62,64,65,70,0,61,0)
4.45
(1.08)
NA
(NA)
4.03
(1.17)
NA
(NA)
4.03
(0.96)
3.66
(1.12)
3.75
(1.13)
3.99
(1.11)
NA
(NA)
4.60
(1.01)
NA
(NA)
Week 6 (n=63,0,61,0,66,67,66,69,0,58,0)
4.32
(1.12)
NA
(NA)
3.74
(1.30)
NA
(NA)
3.68
(1.00)
3.59
(1.27)
3.60
(1.13)
3.94
(1.16)
NA
(NA)
4.35
(1.04)
NA
(NA)
Week 8 (n=63,0,59,0,62,62,67,67,0,58,0)
4.21
(1.22)
NA
(NA)
3.63
(1.27)
NA
(NA)
3.54
(1.01)
3.61
(1.23)
3.38
(1.10)
3.72
(1.35)
NA
(NA)
4.30
(1.08)
NA
(NA)
Week 12 (n=61,0,55,0,60,63,62,65,0,60,0)
3.98
(1.15)
NA
(NA)
3.46
(1.38)
NA
(NA)
3.57
(1.09)
3.40
(1.27)
3.28
(1.25)
3.61
(1.25)
NA
(NA)
4.37
(1.29)
NA
(NA)
Week 16 (n=42,21,43,13,54,64,58,55,9,37,16)
3.59
(1.15)
4.33
(1.16)
3.11
(1.23)
4.19
(1.48)
3.19
(1.10)
3.34
(1.22)
3.12
(1.25)
3.14
(1.06)
4.65
(1.08)
3.93
(1.06)
3.91
(1.19)
Week 20 (n=39,21,44,13,57,63,57,55,12,36,17)
3.48
(1.28)
3.83
(1.62)
3.06
(1.25)
4.24
(1.56)
3.09
(1.17)
3.14
(1.29)
2.94
(1.04)
3.08
(1.11)
4.82
(1.24)
3.81
(1.23)
3.86
(1.24)
Week 24 (n=39,20,42,13,53,63,56,52,12,36,17)
3.39
(1.15)
3.88
(1.49)
3.14
(1.26)
4.08
(1.35)
3.03
(1.05)
3.15
(1.19)
2.91
(1.12)
3.07
(0.98)
4.51
(1.61)
3.48
(1.06)
4.08
(1.37)
21. Secondary Outcome
Title Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET
Description DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
Time Frame Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 64 21 63 13 63 69 68 73 12 61 17
Week 2 (n=64,0,63,0,63,69,68,73,0,61,0)
-0.55
(0.76)
NA
(NA)
-0.78
(0.92)
NA
(NA)
-0.86
(0.82)
-1.07
(0.84)
-1.22
(1.08)
-1.01
(0.97)
NA
(NA)
-0.26
(0.78)
NA
(NA)
Week 4 (n=65,0,61,0,62,64,65,69,0,61,0)
-0.99
(0.91)
NA
(NA)
-1.23
(1.19)
NA
(NA)
-1.09
(0.94)
-1.58
(1.09)
-1.71
(1.20)
-1.30
(1.06)
NA
(NA)
-0.57
(0.88)
NA
(NA)
Week 6 (n=63,0,61,0,66,67,66,69,0,58,0)
-1.13
(1.03)
NA
(NA)
-1.52
(1.27)
NA
(NA)
-1.44
(0.99)
-1.66
(1.18)
-1.81
(1.17)
-1.38
(1.07)
NA
(NA)
-0.80
(0.93)
NA
(NA)
Week 8 (n=63,0,59,0,62,62,67,67,0,58,0)
-1.22
(1.14)
NA
(NA)
-1.61
(1.18)
NA
(NA)
-1.56
(0.97)
-1.63
(1.25)
-2.02
(1.14)
-1.63
(1.17)
NA
(NA)
-0.83
(1.11)
NA
(NA)
Week 12 (n=61,0,55,0,60,63,62,65,0,60,0)
-1.45
(1.13)
NA
(NA)
-1.85
(1.27)
NA
(NA)
-1.59
(1.18)
-1.82
(1.17)
-2.13
(1.32)
-1.72
(1.13)
NA
(NA)
-0.82
(1.11)
NA
(NA)
Week 16 (n=42,21,43,13,54,64,58,55,9,37,16)
-1.87
(1.13)
-1.14
(0.99)
-2.27
(1.14)
-0.81
(1.20)
-1.93
(1.12)
-1.89
(1.13)
-2.31
(1.39)
-2.13
(1.04)
-0.88
(0.95)
-1.14
(1.03)
-1.43
(0.70)
Week 20 (n=39,21,44,13,57,63,57,55,12,36,17)
-1.94
(1.26)
-1.64
(1.25)
-2.41
(1.26)
-0.76
(1.22)
-2.05
(1.15)
-2.09
(1.28)
-2.49
(1.26)
-2.17
(0.96)
-0.95
(0.81)
-1.27
(1.37)
-1.47
(1.04)
Week 24 (n=39,20,42,13,53,63,56,52,12,36,17)
-2.06
(1.22)
-1.55
(1.07)
-2.29
(1.19)
-0.92
(1.17)
-2.06
(1.04)
-2.13
(1.12)
-2.49
(1.27)
-2.19
(1.04)
-1.26
(1.23)
-1.55
(1.25)
-1.25
(0.96)
22. Secondary Outcome
Title Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)
Description Disease improvement was classified as good, moderate, and none based on improvement in DAS 28-3 (CRP) from baseline and present DAS 28-3 (CRP) score. Good: an improvement from baseline of >1.2 and a present score of <=3.2; none: an improvement of <=0.6 or >0.6 to <=1.2 with a present score of >5.1; remaining participants were classified as having moderate (Mod) improvement. Scores of good and moderate were considered to have therapeutic response.
Time Frame Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 64 21 63 13 63 69 68 74 12 61 17
Week 2: Good (n=64,0,63,0,63,69,68,74,0,61,0)
4.7
6.7%
NA
NaN
4.8
6.8%
NA
NaN
9.5
12.7%
13.0
16.3%
16.2
23.5%
12.2
2.4%
NA
NaN
3.3
NaN
NA
NaN
Week 2: Mod (n=64,0,63,0,63,69,68,74,0,61,0)
23.4
33.4%
NA
NaN
44.4
62.5%
NA
NaN
42.9
57.2%
46.4
58%
50.0
72.5%
41.9
8.3%
NA
NaN
23.0
NaN
NA
NaN
Week 2: None (n=64,0,63,0,63,69,68,74,0,61,0)
71.9
102.7%
NA
NaN
50.8
71.5%
NA
NaN
47.6
63.5%
40.6
50.8%
33.8
49%
44.6
8.8%
NA
NaN
73.8
NaN
NA
NaN
Week 4: Good (n=65,0,61,0,62,64,65,70,0,61,0)
10.8
15.4%
NA
NaN
21.3
30%
NA
NaN
16.1
21.5%
28.1
35.1%
30.8
44.6%
21.4
4.2%
NA
NaN
8.2
NaN
NA
NaN
Week 4: Mod (n=65,0,61,0,62,64,65,70,0,61,0)
41.5
59.3%
NA
NaN
45.9
64.6%
NA
NaN
48.4
64.5%
53.1
66.4%
49.2
71.3%
42.9
8.5%
NA
NaN
34.4
NaN
NA
NaN
Week 4: None (n=65,0,61,0,62,64,65,70,0,61,0)
47.7
68.1%
NA
NaN
32.8
46.2%
NA
NaN
35.5
47.3%
18.8
23.5%
20.0
29%
34.3
6.8%
NA
NaN
57.4
NaN
NA
NaN
Week 6: Good (n=63,0,61,0,66,67,66,69,0,58,0)
11.1
15.9%
NA
NaN
29.5
41.5%
NA
NaN
31.8
42.4%
29.9
37.4%
31.8
46.1%
23.2
4.6%
NA
NaN
12.1
NaN
NA
NaN
Week 6: Mod (n=63,0,61,0,66,67,66,69,0,58,0)
50.8
72.6%
NA
NaN
42.6
60%
NA
NaN
42.4
56.5%
50.7
63.4%
50.0
72.5%
44.9
8.9%
NA
NaN
43.1
NaN
NA
NaN
Week 6: None (n=63,0,61,0,66,67,66,69,0,58,0)
38.1
54.4%
NA
NaN
27.9
39.3%
NA
NaN
25.8
34.4%
19.4
24.3%
18.2
26.4%
31.9
6.3%
NA
NaN
44.8
NaN
NA
NaN
Week 8: Good (n=63,0,59,0,62,62,67,67,0,58,0)
19.0
27.1%
NA
NaN
30.5
43%
NA
NaN
37.1
49.5%
32.3
40.4%
43.3
62.8%
37.3
7.4%
NA
NaN
13.8
NaN
NA
NaN
Week 8: Mod (n=63,0,59,0,62,62,67,67,0,58,0)
46.0
65.7%
NA
NaN
47.5
66.9%
NA
NaN
46.8
62.4%
45.2
56.5%
47.8
69.3%
40.3
7.9%
NA
NaN
46.6
NaN
NA
NaN
Week 8: None (n=63,0,59,0,62,62,67,67,0,58,0)
34.9
49.9%
NA
NaN
22.0
31%
NA
NaN
16.1
21.5%
22.6
28.3%
9.0
13%
22.4
4.4%
NA
NaN
39.7
NaN
NA
NaN
Week 12: Good (n=61,0,55,0,60,63,62,65,0,60,0)
23.0
32.9%
NA
NaN
45.5
64.1%
NA
NaN
33.3
44.4%
41.3
51.6%
51.6
74.8%
36.9
7.3%
NA
NaN
16.7
NaN
NA
NaN
Week 12: Mod (n=61,0,55,0,60,63,62,65,0,60,0)
49.2
70.3%
NA
NaN
32.7
46.1%
NA
NaN
50.0
66.7%
39.7
49.6%
37.1
53.8%
44.6
8.8%
NA
NaN
36.7
NaN
NA
NaN
Week 12: None (n=61,0,55,0,60,63,62,65,0,60,0)
27.9
39.9%
NA
NaN
21.8
30.7%
NA
NaN
16.7
22.3%
19.0
23.8%
11.3
16.4%
18.5
3.6%
NA
NaN
46.7
NaN
NA
NaN
Week 16: Good (n=42,21,43,13,54,64,58,55,9,37,16)
40.5
57.9%
19.0
27.9%
55.8
78.6%
30.8
41.6%
51.9
69.2%
50.0
62.5%
48.3
70%
52.7
10.4%
11.1
NaN
27.0
NaN
18.8
NaN
Week 16: Mod (n=42,21,43,13,54,64,58,55,9,37,16)
50.0
71.4%
38.1
56%
32.6
45.9%
23.1
31.2%
37.0
49.3%
34.4
43%
43.1
62.5%
43.6
8.6%
33.3
NaN
40.5
NaN
62.5
NaN
Week 16: None (n=42,21,43,13,54,64,58,55,9,37,16)
9.5
13.6%
42.9
63.1%
11.6
16.3%
46.2
62.4%
11.1
14.8%
15.6
19.5%
8.6
12.5%
3.6
0.7%
55.6
NaN
32.4
NaN
18.8
NaN
Week 20: Good (n=39,21,44,13,57,63,57,55,12,36,17)
46.2
66%
42.9
63.1%
59.1
83.2%
15.4
20.8%
61.4
81.9%
52.4
65.5%
57.9
83.9%
52.7
10.4%
0.0
NaN
30.6
NaN
29.4
NaN
Week 20: Mod (n=39,21,44,13,57,63,57,55,12,36,17)
43.6
62.3%
28.6
42.1%
31.8
44.8%
46.2
62.4%
28.1
37.5%
36.5
45.6%
35.1
50.9%
40.0
7.9%
58.3
NaN
36.1
NaN
47.1
NaN
Week 20: None (n=39,21,44,13,57,63,57,55,12,36,17)
10.3
14.7%
28.6
42.1%
9.1
12.8%
38.5
52%
10.5
14%
11.1
13.9%
7.0
10.1%
7.3
1.4%
41.7
NaN
33.3
NaN
23.5
NaN
Week 24: Good (n=39,20,42,13,53,63,56,52,12,36,17)
43.6
62.3%
35.0
51.5%
54.8
77.2%
23.1
31.2%
52.8
70.4%
58.7
73.4%
66.1
95.8%
59.6
11.8%
25.0
NaN
33.3
NaN
23.5
NaN
Week 24: Mod (n=39,20,42,13,53,63,56,52,12,36,17)
46.2
66%
35.0
51.5%
33.3
46.9%
38.5
52%
37.7
50.3%
30.2
37.8%
23.2
33.6%
34.6
6.8%
33.3
NaN
41.7
NaN
47.1
NaN
Week 24: None (n=39,20,42,13,53,63,56,52,12,36,17)
10.3
14.7%
30.0
44.1%
11.9
16.8%
38.5
52%
9.4
12.5%
11.1
13.9%
10.7
15.5%
5.8
1.1%
41.7
NaN
25.0
NaN
29.4
NaN
23. Secondary Outcome
Title Percentage of Participants With Disease Remission Based on DAS28-3 (CRP)
Description DAS28-3 (CRP) defined remission was classified as a score of <2.6.
Time Frame Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 64 21 63 13 63 68 68 74 12 61 17
Week 2 (n=64,0,63,0,63,68,68,74,0,61,0)
1.56
2.2%
NA
NaN
3.17
4.5%
NA
NaN
1.59
2.1%
4.41
5.5%
13.24
19.2%
4.05
0.8%
NA
NaN
3.28
NaN
NA
NaN
Week 4 (n=65,0,61,0,62,63,65,70,0,61,0)
4.62
6.6%
NA
NaN
14.75
20.8%
NA
NaN
8.06
10.7%
19.05
23.8%
16.92
24.5%
10.00
2%
NA
NaN
3.28
NaN
NA
NaN
Week 6 (n=63,0,61,0,66,66,66,69,0,58,0)
3.17
4.5%
NA
NaN
19.67
27.7%
NA
NaN
13.64
18.2%
24.24
30.3%
22.73
32.9%
10.14
2%
NA
NaN
3.45
NaN
NA
NaN
Week 8 (n=63,0,59,0,62,61,67,67,0,58,0)
7.94
11.3%
NA
NaN
22.03
31%
NA
NaN
19.35
25.8%
21.31
26.6%
23.88
34.6%
20.90
4.1%
NA
NaN
6.90
NaN
NA
NaN
Week 12 (n=61,0,55,0,60,62,62,65,0,60,0)
6.56
9.4%
NA
NaN
30.91
43.5%
NA
NaN
16.67
22.2%
32.26
40.3%
37.10
53.8%
24.62
4.9%
NA
NaN
6.67
NaN
NA
NaN
Week 16 (n=42,21,43,13,54,63,58,55,9,37,16)
14.3
20.4%
9.5
14%
41.9
59%
23.1
31.2%
24.1
32.1%
30.2
37.8%
37.9
54.9%
29.1
5.7%
11.1
NaN
8.1
NaN
12.5
NaN
Week 20 (n=39,21,44,13,57,62,57,55,12,36,17)
20.5
29.3%
28.6
42.1%
43.2
60.8%
15.4
20.8%
35.1
46.8%
37.1
46.4%
38.6
55.9%
30.9
6.1%
0.0
NaN
13.9
NaN
17.6
NaN
Week 24 (n=39,20,42,13,53,63,56,52,12,36,17)
23.1
33%
25.0
36.8%
35.7
50.3%
15.4
20.8%
41.5
55.3%
36.5
45.6%
39.3
57%
32.7
6.4%
16.7
NaN
19.4
NaN
17.6
NaN
24. Secondary Outcome
Title 36-Item Short-Form Health Survey (SF-36)
Description SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Time Frame Baseline, Week 12, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 70 20 68 13 71 73 75 80 12 69 17
Baseline: Ph Fn (n=70,0,68,0,71,73,75,80,0,69,0)
31.48
(10.33)
NA
(NA)
33.20
(11.04)
NA
(NA)
31.93
(9.66)
31.92
(9.15)
31.50
(9.29)
30.23
(9.70)
NA
(NA)
34.01
(11.06)
NA
(NA)
Baseline: R-P (n=70,0,68,0,71,73,75,80,0,69,0)
34.53
(8.52)
NA
(NA)
34.45
(10.52)
NA
(NA)
35.54
(8.69)
34.64
(10.72)
33.70
(9.85)
33.13
(9.32)
NA
(NA)
37.23
(9.51)
NA
(NA)
Baseline: BP (n=70,0,68,0,71,73,75,80,0,69,0)
34.14
(6.60)
NA
(NA)
34.60
(8.35)
NA
(NA)
35.36
(8.23)
35.11
(7.85)
34.98
(8.19)
34.20
(8.18)
NA
(NA)
35.93
(8.71)
NA
(NA)
Baseline: GH (n=70,0,68,0,71,73,75,80,0,69,0)
35.08
(6.77)
NA
(NA)
35.17
(8.02)
NA
(NA)
35.12
(8.90)
36.52
(9.28)
35.94
(8.44)
36.08
(8.48)
NA
(NA)
36.50
(9.38)
NA
(NA)
Baseline: Vit (n=70,0,68,0,71,73,75,80,0,69,0)
40.32
(9.95)
NA
(NA)
42.36
(10.07)
NA
(NA)
41.54
(9.39)
42.60
(10.83)
40.81
(11.75)
40.97
(9.98)
NA
(NA)
44.08
(11.63)
NA
(NA)
Baseline: So Fn (n=70,0,68,0,71,73,75,80,0,69,0)
37.76
(10.41)
NA
(NA)
38.88
(11.35)
NA
(NA)
37.72
(10.38)
38.99
(10.80)
38.01
(11.06)
38.03
(10.70)
NA
(NA)
40.09
(11.08)
NA
(NA)
Baseline: R-E (n=70,0,68,0,71,73,75,80,0,69,0)
34.72
(11.55)
NA
(NA)
35.18
(14.16)
NA
(NA)
37.21
(12.51)
36.23
(12.64)
34.73
(14.42)
35.13
(13.45)
NA
(NA)
39.37
(13.94)
NA
(NA)
Baseline: MnH (n=70,0,68,0,71,73,75,80,0,69,0)
38.98
(11.58)
NA
(NA)
40.07
(11.65)
NA
(NA)
41.88
(12.02)
42.79
(10.99)
39.68
(12.65)
39.91
(12.53)
NA
(NA)
42.91
(13.08)
NA
(NA)
Baseline: Ph C (n=70,0,68,0,71,73,75,80,0,69,0)
33.13
(6.72)
NA
(NA)
33.73
(8.33)
NA
(NA)
32.99
(8.03)
32.96
(8.15)
33.19
(7.31)
32.11
(8.57)
NA
(NA)
34.41
(8.59)
NA
(NA)
Baseline: Mn C (n=70,0,68,0,71,73,75,80,0,69,0)
40.39
(11.42)
NA
(NA)
41.47
(12.68)
NA
(NA)
42.81
(11.80)
43.53
(11.00)
40.92
(13.00)
41.68
(12.17)
NA
(NA)
44.72
(13.24)
NA
(NA)
Week 12: Ph Fn (n=63,0,59,0,64,65,65,70,0,61,0)
35.05
(10.73)
NA
(NA)
36.49
(11.63)
NA
(NA)
36.45
(9.78)
36.25
(10.75)
37.80
(10.76)
37.49
(11.48)
NA
(NA)
36.23
(11.37)
NA
(NA)
Week 12: R-P (n=63,0,59,0,64,65,65,70,0,61,0)
38.47
(8.77)
NA
(NA)
39.25
(10.85)
NA
(NA)
38.26
(10.21)
39.71
(9.69)
39.41
(10.03)
40.17
(10.41)
NA
(NA)
39.79
(10.14)
NA
(NA)
Week 12: BP (n=63,0,59,0,64,65,65,70,0,61,0)
41.62
(8.02)
NA
(NA)
42.76
(11.30)
NA
(NA)
42.73
(9.57)
44.00
(10.81)
44.39
(9.40)
44.21
(9.78)
NA
(NA)
39.46
(10.15)
NA
(NA)
Week 12: GH (n=63,0,59,0,64,65,65,70,0,61,0)
37.85
(8.10)
NA
(NA)
39.04
(8.74)
NA
(NA)
40.11
(9.54)
39.15
(8.76)
40.05
(9.44)
41.10
(9.78)
NA
(NA)
39.54
(10.42)
NA
(NA)
Week 12: Vit (n=63,0,59,0,64,65,65,70,0,61,0)
45.45
(9.82)
NA
(NA)
46.80
(10.08)
NA
(NA)
46.33
(10.59)
45.99
(10.68)
47.82
(10.24)
46.03
(11.42)
NA
(NA)
46.48
(12.24)
NA
(NA)
Week 12: So Fn (n=63,0,59,0,64,65,65,70,0,61,0)
41.18
(11.32)
NA
(NA)
43.54
(11.20)
NA
(NA)
42.28
(10.82)
42.84
(10.06)
43.93
(9.81)
44.23
(10.53)
NA
(NA)
41.38
(10.87)
NA
(NA)
Week 12: R-E (n=63,0,59,0,64,65,65,70,0,61,0)
39.47
(12.12)
NA
(NA)
39.14
(12.47)
NA
(NA)
39.90
(12.87)
39.01
(12.07)
39.07
(11.96)
41.33
(13.30)
NA
(NA)
40.39
(12.49)
NA
(NA)
Week 12: MnH (n=63,0,59,0,64,65,65,70,0,61,0)
43.84
(10.95)
NA
(NA)
44.57
(10.95)
NA
(NA)
45.34
(13.08)
43.08
(9.84)
45.24
(10.70)
46.11
(11.49)
NA
(NA)
43.36
(12.67)
NA
(NA)
Week 12: Ph C (n=63,0,59,0,64,65,65,70,0,61,0)
37.24
(8.19)
NA
(NA)
38.70
(9.73)
NA
(NA)
38.27
(9.31)
39.52
(9.30)
39.97
(8.98)
39.64
(10.20)
NA
(NA)
37.89
(9.94)
NA
(NA)
Week 12: Mn C (n=63,0,59,0,64,65,65,70,0,61,0)
44.86
(11.45)
NA
(NA)
45.47
(11.10)
NA
(NA)
45.84
(13.41)
44.18
(10.26)
45.61
(10.59)
46.65
(11.64)
NA
(NA)
45.08
(12.48)
NA
(NA)
Week 24: Ph Fn(n=40,20,44,13,55,64,60,53,12,36,17)
37.41
(10.35)
34.30
(10.72)
38.38
(11.35)
39.39
(11.83)
40.04
(10.81)
38.19
(10.88)
38.62
(11.08)
40.51
(12.11)
32.31
(11.36)
39.44
(10.64)
38.09
(10.04)
Week 24: R-P (n=40,20,44,13,55,64,60,53,12,36,17)
40.51
(8.53)
35.06
(9.36)
39.88
(11.85)
38.96
(10.26)
41.09
(9.12)
40.32
(10.91)
40.69
(9.67)
41.97
(10.80)
35.02
(10.72)
44.27
(9.80)
42.45
(9.44)
Week 24: BP (n=40,20,44,13,55,64,60,53,12,36,17)
44.17
(8.68)
39.57
(11.54)
44.15
(10.31)
43.07
(9.91)
44.96
(9.23)
44.52
(10.98)
45.76
(9.67)
46.89
(10.25)
40.32
(11.00)
43.11
(9.54)
44.24
(8.09)
Week 24: GH (n=40,20,44,13,55,64,60,53,12,36,17)
40.65
(7.40)
36.87
(7.75)
41.45
(10.05)
37.35
(5.95)
41.35
(10.23)
41.09
(9.27)
41.40
(9.24)
44.03
(9.52)
35.81
(11.52)
43.16
(9.70)
40.68
(8.34)
Week 24: Vit (n=40,20,44,13,55,64,60,53,12,36,17)
49.05
(10.69)
39.60
(9.23)
48.76
(11.25)
47.29
(6.58)
48.40
(10.41)
47.55
(10.18)
50.11
(11.68)
50.50
(10.98)
41.94
(13.65)
49.75
(11.83)
48.23
(11.92)
Week 24: So Fn(n=40,20,44,13,55,64,60,53,12,36,17)
43.62
(10.40)
39.40
(10.26)
42.84
(12.53)
43.84
(9.05)
45.25
(11.64)
43.56
(10.73)
44.67
(10.31)
46.35
(10.53)
38.67
(12.38)
45.18
(10.60)
43.05
(10.04)
Week 24: R-E (n=40,20,44,13,55,64,60,53,12,36,17)
40.23
(11.08)
34.30
(10.59)
40.59
(13.86)
37.94
(12.35)
41.46
(12.40)
40.15
(11.58)
40.39
(11.88)
42.31
(13.71)
37.09
(16.56)
42.27
(13.09)
46.28
(9.13)
Week 24: MnH (n=40,20,44,13,55,64,60,53,12,36,17)
45.92
(11.10)
38.74
(10.58)
45.66
(12.59)
44.59
(7.04)
47.29
(13.62)
43.89
(10.93)
46.86
(11.73)
47.24
(11.36)
43.44
(12.84)
45.63
(14.22)
47.52
(11.26)
Week 24: Ph C (n=40,20,44,13,55,64,60,53,12,36,17)
39.94
(8.41)
36.79
(9.76)
40.31
(9.95)
39.74
(9.76)
41.12
(9.22)
40.85
(9.79)
40.99
(9.14)
42.81
(10.22)
34.40
(10.57)
42.09
(9.20)
39.41
(9.58)
Week 24: Mn C(n=40,20,44,13,55,64,60,53,12,36,17)
46.62
(12.04)
39.10
(11.18)
46.21
(13.26)
44.52
(7.18)
47.34
(13.41)
45.03
(11.20)
47.21
(11.71)
48.03
(11.81)
43.35
(13.89)
47.08
(15.31)
49.27
(9.52)
25. Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET
Description SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Time Frame Baseline, Week 12, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 63 20 59 13 64 64 65 70 12 61 17
Week 12: Ph Fn (n=63,0,59,0,64,64,65,70,0,61,0)
3.98
(7.08)
NA
(NA)
3.39
(9.60)
NA
(NA)
4.57
(8.25)
4.18
(11.13)
5.96
(8.21)
7.40
(9.15)
NA
(NA)
2.24
(8.79)
NA
(NA)
Week 12: R-P (n=63,0,59,0,64,64,65,70,0,61,0)
3.77
(8.00)
NA
(NA)
4.61
(11.45)
NA
(NA)
2.68
(9.44)
4.52
(11.62)
5.20
(9.27)
6.86
(9.69)
NA
(NA)
2.01
(9.91)
NA
(NA)
Week 12: BP (n=63,0,59,0,64,64,65,70,0,61,0)
7.29
(8.12)
NA
(NA)
8.80
(11.96)
NA
(NA)
7.28
(10.29)
8.74
(10.66)
9.23
(9.48)
10.54
(9.16)
NA
(NA)
3.23
(8.98)
NA
(NA)
Week 12: GH (n=63,0,59,0,64,64,65,70,0,61,0)
2.94
(7.04)
NA
(NA)
3.84
(7.61)
NA
(NA)
4.78
(8.81)
2.73
(7.46)
4.32
(8.59)
4.97
(9.64)
NA
(NA)
2.47
(10.32)
NA
(NA)
Week 12: Vit (n=63,0,59,0,64,64,65,70,0,61,0)
5.10
(8.99)
NA
(NA)
4.29
(9.92)
NA
(NA)
4.68
(9.86)
2.29
(8.80)
6.87
(8.76)
5.22
(8.28)
NA
(NA)
1.45
(11.66)
NA
(NA)
Week 12: So Fn (n=63,0,59,0,64,64,65,70,0,61,0)
3.72
(10.54)
NA
(NA)
4.99
(10.54)
NA
(NA)
4.26
(9.93)
3.49
(11.84)
4.70
(10.33)
5.84
(12.43)
NA
(NA)
0.80
(9.70)
NA
(NA)
Week 12: R-E (n=63,0,59,0,64,64,65,70,0,61,0)
4.26
(10.65)
NA
(NA)
3.69
(13.12)
NA
(NA)
2.25
(11.23)
2.73
(13.28)
3.77
(13.04)
5.33
(12.06)
NA
(NA)
-0.96
(12.04)
NA
(NA)
Week 12: MnH (n=63,0,59,0,64,64,65,70,0,61,0)
4.92
(9.27)
NA
(NA)
4.63
(10.01)
NA
(NA)
3.43
(10.19)
0.04
(9.08)
4.68
(8.73)
5.59
(9.87)
NA
(NA)
-0.88
(9.76)
NA
(NA)
Week 12: Ph C (n=63,0,59,0,64,64,65,70,0,61,0)
4.27
(6.38)
NA
(NA)
5.16
(8.82)
NA
(NA)
5.30
(8.03)
6.32
(8.72)
6.77
(7.29)
7.98
(7.95)
NA
(NA)
3.71
(7.43)
NA
(NA)
Week 12: Mn C (n=63,0,59,0,64,64,65,70,0,61,0)
4.30
(9.47)
NA
(NA)
3.94
(10.38)
NA
(NA)
2.72
(9.57)
0.28
(10.13)
3.81
(9.58)
4.18
(10.04)
NA
(NA)
-1.40
(9.18)
NA
(NA)
Week 24: Ph Fn(n=40,20,44,13,55,63,60,53,12,36,17)
6.52
(8.32)
2.63
(9.94)
5.45
(8.57)
4.37
(8.35)
7.77
(9.41)
6.41
(11.62)
6.63
(10.30)
8.81
(10.48)
6.49
(8.15)
3.74
(9.56)
4.21
(9.84)
Week 24: R-P (n=40,20,44,13,55,63,60,53,12,36,17)
6.12
(8.34)
1.47
(7.72)
5.07
(11.00)
4.52
(6.77)
6.01
(10.23)
5.56
(9.76)
6.61
(9.33)
7.25
(11.27)
5.51
(10.50)
5.85
(11.43)
4.75
(8.64)
Week 24: BP (n=40,20,44,13,55,63,60,53,12,36,17)
10.65
(9.91)
3.85
(8.92)
10.16
(9.54)
9.75
(7.27)
10.09
(10.44)
9.21
(10.31)
10.44
(10.51)
11.86
(10.67)
10.67
(12.01)
5.92
(10.51)
7.73
(7.63)
Week 24: GH (n=40,20,44,13,55,63,60,53,12,36,17)
5.62
(7.70)
3.58
(6.97)
5.92
(7.09)
4.11
(9.07)
6.34
(7.85)
4.68
(8.77)
5.41
(7.88)
6.43
(8.93)
5.92
(9.84)
4.20
(12.05)
4.04
(3.82)
Week 24: Vit (n=40,20,44,13,55,63,60,53,12,36,17)
8.12
(9.94)
1.56
(10.79)
5.82
(9.30)
5.04
(10.16)
6.64
(9.03)
3.52
(9.27)
8.53
(9.99)
7.95
(11.17)
6.76
(11.52)
2.08
(13.86)
6.06
(6.19)
Week 24: So Fn(n=40,20,44,13,55,63,60,53,12,36,17)
5.86
(9.36)
3.27
(12.31)
4.09
(11.10)
5.87
(10.31)
7.54
(10.36)
4.16
(11.99)
4.91
(10.27)
6.79
(11.86)
3.64
(11.71)
3.33
(12.73)
3.85
(9.20)
Week 24: R-E (n=40,20,44,13,55,63,60,53,12,36,17)
4.28
(11.30)
2.33
(12.82)
5.48
(16.05)
-0.30
(13.69)
4.24
(11.81)
4.01
(13.30)
5.18
(11.73)
5.57
(14.61)
2.27
(16.86)
0.97
(13.70)
2.29
(11.17)
Week 24: MnH (n=40,20,44,13,55,63,60,53,12,36,17)
7.25
(12.82)
1.83
(8.73)
4.99
(11.52)
4.98
(11.27)
5.43
(11.92)
0.36
(10.48)
5.44
(8.23)
5.31
(12.73)
6.57
(12.84)
0.70
(9.97)
0.99
(10.10)
Week 24: Ph C (n=40,20,44,13,55,63,60,53,12,36,17)
7.47
(7.90)
2.91
(7.31)
6.78
(7.17)
6.62
(5.93)
8.31
(8.48)
7.99
(9.21)
7.81
(8.84)
9.59
(8.67)
7.83
(7.89)
6.26
(9.97)
6.40
(8.08)
Week 24: Mn C (n=40,20,44,13,55,63,60,53,12,36,17)
5.48
(12.35)
1.93
(11.99)
4.31
(13.10)
2.48
(11.80)
4.46
(10.55)
0.73
(10.85)
4.78
(9.04)
4.52
(12.52)
3.44
(14.10)
-0.07
(12.42)
1.57
(8.22)
26. Secondary Outcome
Title Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility Score
Description EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame Baseline, Week 12, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 70 21 68 13 71 74 75 80 12 69 17
Baseline (n=70,0,68,0,71,74,75,80,0,69,0)
0.45
(0.29)
NA
(NA)
0.46
(0.33)
NA
(NA)
0.50
(0.30)
0.48
(0.28)
0.46
(0.31)
0.49
(0.28)
NA
(NA)
0.49
(0.33)
NA
(NA)
Week 12 (n=63,0,59,0,64,65,64,70,0,61,0)
0.63
(0.20)
NA
(NA)
0.59
(0.30)
NA
(NA)
0.62
(0.26)
0.65
(0.23)
0.63
(0.27)
0.64
(0.25)
NA
(NA)
0.55
(0.31)
NA
(NA)
Week 24 (n=40,20,44,13,55,63,60,52,12,36,17)
0.66
(0.23)
0.46
(0.42)
0.67
(0.26)
0.64
(0.25)
0.70
(0.23)
0.68
(0.23)
0.65
(0.25)
0.71
(0.27)
0.56
(0.32)
0.65
(0.22)
0.58
(0.32)
27. Secondary Outcome
Title Change From Baseline in Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility at Week 12 and 24/ET
Description EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame Baseline, Week 12, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 63 20 59 13 64 65 64 70 12 61 17
Week 12 (n=63,0,59,0,64,65,64,70,0,61,0)
0.15
(0.26)
NA
(NA)
0.16
(0.37)
NA
(NA)
0.11
(0.32)
0.17
(0.27)
0.18
(0.29)
0.16
(0.29)
NA
(NA)
0.05
(0.35)
NA
(NA)
Week 24 (n=40,20,44,13,55,63,60,52,12,36,17)
0.20
(0.30)
0.00
(0.30)
0.23
(0.33)
0.23
(0.37)
0.19
(0.30)
0.20
(0.31)
0.18
(0.29)
0.17
(0.32)
0.20
(0.45)
0.13
(0.30)
0.03
(0.29)
28. Secondary Outcome
Title Medical Outcome Study- Sleep Scale (MOS-SS)
Description Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0)and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time Frame Baseline, Week 2, 12, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 70 21 68 13 71 74 75 80 12 69 17
Baseline: SPS (n=70,0,68,0,71,74,74,80,0,69,0)
40.62
(18.87)
NA
(NA)
44.46
(21.58)
NA
(NA)
38.12
(18.93)
36.94
(18.49)
40.90
(22.41)
38.46
(21.21)
NA
(NA)
38.26
(19.58)
NA
(NA)
Baseline: OSP (n=70,0,68,0,71,74,74,79,0,69,0)
41.94
(18.04)
NA
(NA)
45.65
(20.86)
NA
(NA)
40.22
(19.00)
39.05
(18.56)
42.87
(20.62)
40.49
(21.33)
NA
(NA)
38.86
(19.24)
NA
(NA)
Baseline: Ade (n=70,0,68,0,71,74,74,80,0,69,0)
48.14
(25.50)
NA
(NA)
43.82
(26.99)
NA
(NA)
46.20
(27.95)
50.27
(26.84)
49.19
(28.13)
51.00
(30.55)
NA
(NA)
51.45
(28.45)
NA
(NA)
Baseline: ASOB (n=70,0,68,0,71,74,75,80,0,69,0)
20.00
(24.55)
NA
(NA)
22.94
(24.50)
NA
(NA)
17.75
(22.82)
17.30
(22.29)
21.87
(25.93)
20.50
(27.55)
NA
(NA)
22.61
(25.88)
NA
(NA)
Baseline: SD (n=70,0,68,0,71,74,75,80,0,69,0)
44.43
(23.13)
NA
(NA)
49.10
(27.47)
NA
(NA)
42.61
(25.40)
41.17
(25.36)
48.37
(25.66)
44.42
(27.37)
NA
(NA)
40.34
(26.04)
NA
(NA)
Baseline: Opt (n=70,0,68,0,71,74,75,80,0,69,0)
0.51
(0.50)
NA
(NA)
0.44
(0.50)
NA
(NA)
0.46
(0.50)
0.45
(0.50)
0.47
(0.50)
0.50
(0.50)
NA
(NA)
0.52
(0.50)
NA
(NA)
Baseline: Qua (n=70,0,67,0,71,74,75,78,0,69,0)
6.87
(1.73)
NA
(NA)
6.72
(1.60)
NA
(NA)
7.32
(7.65)
7.28
(3.54)
6.64
(1.61)
6.90
(1.52)
NA
(NA)
6.71
(1.47)
NA
(NA)
Baseline: Sno (n=69,0,68,0,71,74,74,80,0,69,0)
31.59
(30.76)
NA
(NA)
35.29
(32.07)
NA
(NA)
44.51
(33.16)
39.73
(33.19)
36.00
(34.01)
35.25
(32.49)
NA
(NA)
35.94
(33.88)
NA
(NA)
Baseline: Som (n=70,0,68,0,71,74,75,78,0,69,0)
35.14
(20.30)
NA
(NA)
38.63
(23.51)
NA
(NA)
32.86
(19.17)
34.50
(19.03)
35.91
(22.08)
35.04
(22.93)
NA
(NA)
33.04
(20.69)
NA
(NA)
Week 2: SPS (n=67,0,68,0,68,73,73,79,0,65,0)
39.65
(21.00)
NA
(NA)
37.89
(22.17)
NA
(NA)
34.22
(21.10)
35.25
(19.10)
32.97
(21.75)
35.78
(20.40)
NA
(NA)
34.34
(20.21)
NA
(NA)
Week 2: OSP (n=68,0,68,0,68,73,73,79,0,66,0)
39.04
(19.70)
NA
(NA)
37.88
(21.48)
NA
(NA)
34.74
(20.11)
35.65
(19.37)
35.27
(20.56)
36.22
(19.65)
NA
(NA)
35.67
(18.79)
NA
(NA)
Week 2: Ade (n=68,0,68,0,68,73,73,79,0,66,0)
45.15
(27.62)
NA
(NA)
49.56
(28.31)
NA
(NA)
53.24
(31.64)
53.42
(25.40)
57.53
(28.81)
50.51
(27.68)
NA
(NA)
54.24
(29.87)
NA
(NA)
Week 2: ASOB (n=68,0,68,0,68,73,73,79,0,65,0)
20.29
(25.04)
NA
(NA)
17.65
(22.27)
NA
(NA)
17.94
(22.70)
22.74
(24.11)
15.34
(21.74)
20.25
(26.11)
NA
(NA)
17.88
(23.57)
NA
(NA)
Week 2: SD (n=68,0,68,0,68,73,73,79,0,66,0)
39.15
(22.53)
NA
(NA)
39.21
(27.05)
NA
(NA)
35.00
(23.80)
34.93
(24.83)
38.73
(26.23)
35.87
(24.33)
NA
(NA)
37.33
(25.29)
NA
(NA)
Week 2: Opt (n=68,0,68,0,68,73,73,79,0,66,0)
0.41
(0.50)
NA
(NA)
0.43
(0.50)
NA
(NA)
0.53
(0.50)
0.52
(0.50)
0.52
(0.50)
0.44
(0.50)
NA
(NA)
0.59
(0.50)
NA
(NA)
Week 2: Qua (n=68,0,68,0,68,73,73,79,0,66,0)
6.75
(1.73)
NA
(NA)
6.76
(1.40)
NA
(NA)
6.72
(1.26)
7.05
(1.30)
7.10
(1.70)
6.78
(1.65)
NA
(NA)
7.08
(1.53)
NA
(NA)
Week 2: Sno (n=68,0,67,0,68,73,73,79,0,66,0)
32.94
(29.88)
NA
(NA)
35.59
(32.94)
NA
(NA)
37.01
(31.38)
35.62
(33.21)
30.96
(33.01)
30.63
(30.18)
NA
(NA)
35.76
(35.17)
NA
(NA)
Week 2: Som (n=67,0,68,0,68,73,73,79,0,66,0)
32.34
(21.03)
NA
(NA)
33.63
(24.25)
NA
(NA)
31.08
(21.66)
33.79
(20.97)
32.69
(21.26)
31.73
(22.32)
NA
(NA)
30.51
(20.56)
NA
(NA)
Week 12: SPS (n=62,0,59,0,63,65,64,70,0,61,0)
35.05
(16.56)
NA
(NA)
33.62
(22.04)
NA
(NA)
33.39
(20.64)
34.92
(18.85)
35.00
(19.41)
32.81
(21.22)
NA
(NA)
34.26
(22.07)
NA
(NA)
Week 12: OSP (n=62,0,59,0,63,65,64,70,0,61,0)
34.78
(16.37)
NA
(NA)
34.23
(20.63)
NA
(NA)
33.61
(19.83)
35.26
(19.48)
36.33
(19.86)
33.44
(21.57)
NA
(NA)
34.50
(20.96)
NA
(NA)
Week 12: Ade (n=62,0,59,0,63,65,64,70,0,61,0)
49.35
(24.69)
NA
(NA)
54.92
(32.24)
NA
(NA)
53.17
(29.99)
54.00
(26.74)
56.09
(28.21)
58.43
(27.59)
NA
(NA)
54.59
(27.72)
NA
(NA)
Week 12: ASOB (n=62,0,59,0,63,65,64,70,0,61,0)
15.16
(22.52)
NA
(NA)
13.90
(19.39)
NA
(NA)
20.32
(27.24)
20.00
(23.72)
18.75
(22.50)
21.43
(26.00)
NA
(NA)
20.98
(28.85)
NA
(NA)
Week 12: SD (n=62,0,59,0,63,65,64,70,0,61,0)
34.94
(20.00)
NA
(NA)
35.66
(26.03)
NA
(NA)
32.52
(23.96)
34.27
(25.00)
39.16
(25.16)
34.18
(27.10)
NA
(NA)
35.41
(26.22)
NA
(NA)
Week 12: Opt (n=63,0,59,0,64,65,65,70,0,61,0)
0.52
(0.50)
NA
(NA)
0.53
(0.50)
NA
(NA)
0.48
(0.50)
0.54
(0.50)
0.45
(0.50)
0.51
(0.50)
NA
(NA)
0.48
(0.50)
NA
(NA)
Week 12: Qua (n=62,0,58,0,63,65,64,70,0,61,0)
7.08
(1.41)
NA
(NA)
7.05
(1.53)
NA
(NA)
6.71
(1.49)
6.85
(1.33)
6.98
(1.74)
7.60
(5.37)
NA
(NA)
8.10
(9.47)
NA
(NA)
Week 12: Sno (n=61,0,59,0,63,65,64,70,0,61,0)
29.18
(26.97)
NA
(NA)
34.92
(32.71)
NA
(NA)
41.59
(32.19)
35.69
(32.11)
34.69
(32.71)
33.43
(29.63)
NA
(NA)
30.82
(31.53)
NA
(NA)
Week 12: Som (n=62,0,59,0,63,65,64,70,0,61,0)
28.82
(18.61)
NA
(NA)
32.20
(21.52)
NA
(NA)
31.01
(23.10)
34.36
(23.22)
32.29
(20.62)
30.57
(25.16)
NA
(NA)
28.96
(18.77)
NA
(NA)
Week 24: SPS (n=40,20,44,13,55,64,59,52,12,34,17)
32.17
(17.35)
43.67
(20.23)
30.68
(21.02)
38.21
(17.46)
32.55
(22.35)
32.50
(18.22)
29.89
(18.91)
25.45
(17.75)
44.44
(27.09)
29.51
(19.04)
32.55
(22.31)
Week 24: OSP (n=40,20,44,13,55,64,59,52,12,34,17)
31.64
(16.38)
42.86
(19.06)
31.46
(19.54)
38.80
(18.07)
32.18
(21.24)
32.95
(18.88)
31.18
(19.77)
26.76
(17.75)
47.27
(27.08)
30.41
(18.52)
33.04
(21.93)
Week 24: Ade (n=40,20,44,13,55,64,59,52,12,34,17)
57.00
(25.74)
39.50
(27.81)
58.41
(28.69)
46.15
(18.05)
55.64
(31.61)
57.34
(26.32)
57.46
(26.43)
66.92
(28.60)
44.17
(34.50)
57.65
(27.64)
55.29
(33.56)
Week 24: ASOB (n=40,20,44,13,55,64,59,52,12,34,17
14.00
(17.66)
20.00
(26.75)
12.73
(18.85)
18.46
(17.25)
14.18
(20.61)
17.19
(23.33)
11.53
(19.72)
11.15
(18.33)
25.00
(32.05)
13.53
(15.35)
14.12
(25.26)
Week 24: SD (n=40,20,44,13,55,64,59,52,12,34,17)
32.31
(19.05)
40.19
(21.76)
30.80
(24.04)
38.08
(28.62)
32.77
(25.76)
32.73
(26.78)
32.61
(26.23)
28.49
(23.70)
52.19
(29.21)
30.33
(24.00)
36.40
(27.29)
Week 24: Opt (n=40,20,44,13,55,64,60,53,12,36,17)
0.53
(0.51)
0.50
(0.51)
0.55
(0.50)
0.38
(0.51)
0.45
(0.50)
0.55
(0.50)
0.45
(0.50)
0.57
(0.50)
0.33
(0.49)
0.58
(0.50)
0.41
(0.51)
Week 24: Qua (n=40,20,44,13,55,64,59,52,12,34,17)
6.88
(1.44)
6.80
(1.40)
7.25
(1.31)
6.69
(1.65)
7.93
(7.26)
6.94
(1.23)
7.05
(1.85)
7.12
(1.20)
9.42
(12.87)
7.43
(1.09)
6.41
(1.42)
Week 24: Sno (n=40,20,44,13,54,64,59,52,12,34,17)
26.50
(23.70)
38.00
(32.38)
35.00
(31.73)
44.62
(32.82)
37.41
(32.05)
38.13
(33.37)
35.25
(30.25)
38.46
(32.62)
35.00
(28.44)
27.06
(32.62)
34.12
(33.74)
Week 24: Som (n=40,20,44,13,55,64,59,52,12,34,17)
29.50
(19.33)
40.67
(20.85)
34.39
(25.39)
31.79
(18.49)
29.94
(20.68)
32.40
(24.05)
28.70
(19.93)
26.03
(21.42)
33.89
(25.34)
27.06
(17.67)
23.14
(18.12)
29. Secondary Outcome
Title Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET
Description Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range: 0-100); sleep quantity (Qua) (range: 0-24), and optimal (Opt) sleep (yes: 1, no: 0) and 9 item index measures of sleep disturbance were constructed to provide 2 composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range*100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time Frame Baseline, Week 2, 12, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 67 20 68 13 68 73 72 79 12 66 17
Week 2: SPS (n=67,0,68,0,68,73,72,79,0,66,0)
-0.95
(11.35)
NA
(NA)
-6.57
(15.20)
NA
(NA)
-3.43
(16.51)
-2.05
(14.11)
-7.45
(11.74)
-2.36
(17.85)
NA
(NA)
-4.29
(13.12)
NA
(NA)
Week 2: OSP (n=67,0,68,0,68,73,72,78,0,65,0)
-2.94
(10.26)
NA
(NA)
-7.76
(14.28)
NA
(NA)
-4.93
(14.92)
-3.75
(12.36)
-7.06
(10.93)
-4.07
(15.98)
NA
(NA)
-3.30
(12.13)
NA
(NA)
Week 2: Ade (n=68,0,68,0,68,73,72,79,0,66,0)
-3.68
(22.72)
NA
(NA)
5.74
(21.04)
NA
(NA)
6.76
(25.06)
3.70
(26.11)
7.64
(16.74)
-0.51
(28.68)
NA
(NA)
3.18
(19.70)
NA
(NA)
Week 2: ASOB (n=68,0,68,0,68,73,73,79,0,66,0)
-0.29
(19.70)
NA
(NA)
-5.29
(20.62)
NA
(NA)
0.29
(25.27)
5.48
(21.15)
-6.03
(21.78)
0.00
(20.51)
NA
(NA)
-5.76
(25.24)
NA
(NA)
Week 2: SD (n=68,0,68,0,68,73,73,79,0,65,0)
-5.64
(13.23)
NA
(NA)
-9.89
(17.97)
NA
(NA)
-6.82
(18.04)
-6.73
(15.61)
-8.77
(15.11)
-7.85
(20.80)
NA
(NA)
-2.81
(17.05)
NA
(NA)
Week 2: Opt (n=68,0,68,0,68,73,73,79,0,66,0)
-0.10
(0.52)
NA
(NA)
-0.01
(0.47)
NA
(NA)
0.04
(0.44)
0.07
(0.56)
0.04
(0.54)
-0.05
(0.53)
NA
(NA)
0.08
(0.36)
NA
(NA)
Week 2: Qua (n=68,0,67,0,68,73,73,77,0,66,0)
-0.13
(1.21)
NA
(NA)
0.03
(1.07)
NA
(NA)
-0.69
(7.75)
-0.21
(3.75)
0.41
(1.21)
-0.09
(1.16)
NA
(NA)
0.36
(0.99)
NA
(NA)
Week 2: Sno (n=67,0,68,0,67,73,73,79,0,66,0)
3.28
(22.99)
NA
(NA)
0.29
(22.26)
NA
(NA)
-7.46
(21.97)
-4.66
(23.46)
-4.11
(21.33)
-4.05
(23.62)
NA
(NA)
0.91
(23.91)
NA
(NA)
Week 2: Som (n=67,0,68,0,68,73,73,77,0,66,0)
-3.18
(18.47)
NA
(NA)
-5.00
(18.33)
NA
(NA)
-1.37
(18.05)
-0.73
(16.20)
-2.74
(15.79)
-3.03
(17.76)
NA
(NA)
-2.22
(18.47)
NA
(NA)
Week 12: SPS (n=62,0,59,0,63,65,63,70,0,61,0)
-5.54
(12.21)
NA
(NA)
-10.51
(20.72)
NA
(NA)
-3.97
(18.57)
-2.00
(19.98)
-5.19
(19.19)
-4.62
(17.24)
NA
(NA)
-2.95
(18.20)
NA
(NA)
Week 12: OSP (n=62,0,59,0,63,65,63,69,0,61,0)
-7.27
(11.71)
NA
(NA)
-11.21
(18.59)
NA
(NA)
-5.59
(18.71)
-3.64
(18.32)
-5.63
(17.18)
-6.42
(15.31)
NA
(NA)
-3.03
(17.70)
NA
(NA)
Week 12: Ade (n=62,0,59,0,63,65,63,70,0,61,0)
1.45
(22.39)
NA
(NA)
11.19
(27.55)
NA
(NA)
5.87
(27.51)
4.77
(29.32)
6.51
(25.15)
6.57
(32.16)
NA
(NA)
0.82
(23.47)
NA
(NA)
Week 12: ASOB (n=62,0,59,0,63,65,64,70,0,61,0)
-3.87
(24.52)
NA
(NA)
-7.46
(24.89)
NA
(NA)
3.81
(28.70)
2.46
(26.10)
-2.81
(23.87)
1.43
(24.15)
NA
(NA)
-1.97
(25.22)
NA
(NA)
Week 12: SD (n=62,0,59,0,63,65,64,70,0,61,0)
-9.74
(16.98)
NA
(NA)
-13.43
(22.93)
NA
(NA)
-9.25
(23.07)
-6.73
(22.54)
-8.22
(20.59)
-8.45
(18.59)
NA
(NA)
-2.97
(21.46)
NA
(NA)
Week 12: Opt (n=63,0,59,0,64,65,65,70,0,61,0)
0.00
(0.54)
NA
(NA)
0.07
(0.61)
NA
(NA)
0.03
(0.64)
0.08
(0.62)
-0.05
(0.57)
0.01
(0.58)
NA
(NA)
-0.08
(0.53)
NA
(NA)
Week 12: Qua (n=62,0,57,0,63,65,64,68,0,61,0)
0.16
(1.43)
NA
(NA)
0.40
(1.32)
NA
(NA)
-0.73
(8.24)
-0.42
(3.80)
0.28
(1.52)
0.74
(5.57)
NA
(NA)
1.33
(9.25)
NA
(NA)
Week 12: Sno (n=61,0,59,0,63,65,64,70,0,61,0)
0.66
(22.20)
NA
(NA)
-0.34
(27.67)
NA
(NA)
-2.54
(28.85)
-2.15
(26.25)
1.56
(24.25)
-1.14
(22.04)
NA
(NA)
-3.28
(19.38)
NA
(NA)
Week 12: Som (n=62,0,59,0,63,65,64,68,0,61,0)
-6.56
(18.60)
NA
(NA)
-6.33
(19.08)
NA
(NA)
-1.06
(19.20)
1.54
(23.06)
-2.81
(20.33)
-4.90
(20.72)
NA
(NA)
-4.37
(21.56)
NA
(NA)
Week 24: SPS (n=40,20,44,13,55,64,58,52,12,34,17)
-8.25
(15.47)
-0.50
(15.83)
-11.97
(19.23)
-6.92
(18.13)
-4.12
(20.03)
-3.33
(16.38)
-8.62
(18.34)
-7.82
(18.23)
-3.33
(20.84)
-6.27
(19.96)
-2.16
(16.71)
Week 24: OSP (n=40,20,44,13,55,64,58,51,12,34,17)
-10.18
(14.38)
-2.81
(14.39)
-12.16
(17.87)
-8.50
(16.00)
-6.04
(19.83)
-4.83
(16.17)
-9.82
(16.06)
-9.24
(18.00)
-3.38
(18.83)
-6.01
(18.67)
-1.96
(18.70)
Week 24: Ade (n=40,20,44,13,55,64,58,52,12,34,17)
7.75
(26.36)
-6.00
(25.42)
11.59
(24.30)
9.23
(23.97)
8.00
(28.11)
6.72
(29.33)
5.52
(26.70)
11.92
(32.36)
-1.67
(39.73)
-1.18
(29.72)
8.82
(19.00)
Week 24: ASOB (n=40,20,44,13,55,64,59,52,12,34,17)
-3.50
(20.20)
-7.00
(29.22)
-11.36
(27.42)
-1.54
(26.41)
-3.27
(24.27)
0.63
(24.94)
-10.17
(25.56)
-5.38
(19.45)
-6.67
(21.46)
-11.18
(21.57)
3.53
(26.68)
Week 24: SD (n=40,20,44,13,55,64,59,52,12,34,17)
-13.66
(18.64)
-6.31
(17.76)
-15.88
(24.63)
-13.75
(21.22)
-6.59
(25.51)
-6.64
(22.53)
-13.98
(18.70)
-8.94
(22.39)
-7.19
(18.41)
-7.06
(23.78)
-1.18
(27.63)
Week 24: Opt (n=40,20,44,13,55,64,60,53,12,36,17)
0.00
(0.51)
0.00
(0.65)
0.07
(0.62)
-0.08
(0.64)
0.02
(0.62)
0.08
(0.65)
-0.05
(0.53)
0.02
(0.54)
0.00
(0.74)
-0.08
(0.60)
-0.06
(0.56)
Week 24: Qua (n=40,20,43,13,55,64,59,51,11,35,17)
-0.10
(1.26)
0.00
(1.65)
0.35
(1.56)
0.38
(1.66)
0.33
(2.13)
-0.42
(3.97)
0.31
(1.44)
0.08
(1.04)
3.36
(13.89)
0.29
(1.45)
0.24
(1.25)
Week 24: Sno (n=40,19,44,13,54,64,59,52,12,34,17)
3.50
(25.17)
-1.05
(23.55)
2.73
(28.48)
6.15
(18.95)
-7.04
(24.92)
0.31
(28.84)
2.37
(22.92)
1.54
(28.79)
5.00
(30.90)
-6.47
(26.84)
-1.18
(11.11)
Week 24: Som (n=40,20,44,13,55,64,59,51,11,34,17)
-5.33
(21.94)
0.67
(18.34)
-2.58
(20.29)
-4.10
(15.04)
-2.18
(21.08)
-1.04
(20.03)
-6.55
(20.02)
-6.80
(21.19)
-4.24
(18.68)
-7.06
(17.36)
-2.35
(15.45)
30. Secondary Outcome
Title Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale
Description FACIT-Fatigue scale (FS) is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Time Frame Baseline, Week 2, 12, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 70 21 68 13 71 73 75 79 12 69 17
Baseline (n=70,0,68,0,71,73,75,79,0,69,0)
28.17
(10.50)
NA
(NA)
29.92
(11.98)
NA
(NA)
28.76
(10.42)
30.06
(10.85)
29.48
(10.19)
29.76
(11.02)
NA
(NA)
32.23
(11.13)
NA
(NA)
Week 2 (n=68,0,68,0,68,73,73,78,0,66,0)
30.41
(12.01)
NA
(NA)
32.65
(10.64)
NA
(NA)
32.46
(11.78)
32.51
(10.58)
33.41
(10.10)
33.36
(10.93)
NA
(NA)
33.88
(8.90)
NA
(NA)
Week 12 (n=61,0,59,0,63,65,64,69,0,61,0)
33.25
(10.80)
NA
(NA)
35.44
(11.16)
NA
(NA)
34.30
(10.87)
33.17
(9.43)
35.05
(10.17)
33.99
(11.61)
NA
(NA)
35.42
(10.04)
NA
(NA)
Week 24 (n=39,20,44,13,55,64,59,51,12,35,17)
36.69
(10.42)
28.08
(11.07)
35.48
(11.66)
34.92
(9.40)
36.78
(10.75)
35.36
(10.01)
36.80
(9.85)
38.24
(9.46)
29.50
(12.27)
37.17
(10.12)
37.47
(9.87)
31. Secondary Outcome
Title Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET
Description FACIT-FS is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Time Frame Baseline, Week 2, 12, 24/ET

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 5 mg tablet orally twice daily for 24 weeks. CP-690,550 10 mg tablet orally twice daily for 24 weeks. CP-690,550 15 mg tablet orally twice daily for 24 weeks. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks. Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Measure Participants 68 21 68 13 68 72 73 78 12 66 17
Week 2 (n=68,0,68,0,68,72,73,78,0,66,0)
1.96
(7.99)
NA
(NA)
2.74
(7.80)
NA
(NA)
3.54
(7.71)
2.80
(7.40)
3.68
(7.24)
3.37
(6.56)
NA
(NA)
1.61
(6.21)
NA
(NA)
Week 12 (n=61,0,59,0,63,65,64,69,0,61,0)
4.82
(8.53)
NA
(NA)
5.79
(10.95)
NA
(NA)
4.90
(8.98)
2.18
(9.25)
5.41
(9.02)
4.51
(9.27)
NA
(NA)
2.71
(9.94)
NA
(NA)
Week 24 (n=39,20,44,13,55,64,59,50,12,35,17)
6.23
(9.66)
3.73
(10.35)
5.33
(9.42)
5.62
(11.57)
7.18
(9.08)
4.49
(9.43)
6.54
(8.90)
6.88
(9.28)
4.75
(10.84)
3.23
(12.13)
4.18
(6.09)

Adverse Events

Time Frame
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Arm/Group Description CP-690,550 1 mg tablet orally twice daily up to Week 24. CP-690,550 1 mg tablet orally twice daily up to Week 12 followed by CP-690,550 5 mg tablet orally twice up to Week 24. CP-690,550 3 mg tablet orally twice daily up to Week 24. CP-690,550 3 mg tablet orally twice daily up to Week 12 followed by CP-690,550 5 mg tablet orally twice up to Week 24. CP-690,550 5 mg tablet orally twice daily up to Week 24. CP-690,550 10 mg tablet orally twice daily up to Week 24. CP-690,550 15 mg tablet orally twice daily up to Week 24. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose up to Week 24. CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose up to Week 12 followed by CP-690,550 5 mg tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily up to Week 24. Matching placebo tablet orally twice daily up to Week 12 followed by CP-690,550 5 mg tablet orally twice up to Week 24.
All Cause Mortality
CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/49 (2%) 1/21 (4.8%) 4/55 (7.3%) 0/13 (0%) 4/71 (5.6%) 1/74 (1.4%) 6/75 (8%) 4/67 (6%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Cardiac disorders
Atrial fibrillation 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 1/67 (1.5%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Cardiac failure 0/49 (0%) 0/21 (0%) 1/55 (1.8%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Cardiac failure congestive 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 1/71 (1.4%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Eye disorders
Blindness 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 1/71 (1.4%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Gastrointestinal disorders
Food poisoning 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 1/67 (1.5%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Gastric ulcer 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Gastrooesophageal reflux disease 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 1/67 (1.5%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Stomatitis 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
General disorders
Chest discomfort 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Chest pain 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Pyrexia 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 1/67 (1.5%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Infections and infestations
Lower respiratory tract infection 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 1/74 (1.4%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Pneumonia 0/49 (0%) 0/21 (0%) 1/55 (1.8%) 0/13 (0%) 1/71 (1.4%) 0/74 (0%) 0/75 (0%) 1/67 (1.5%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Urinary tract infection 0/49 (0%) 0/21 (0%) 1/55 (1.8%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Injury, poisoning and procedural complications
Ankle fracture 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia 0/49 (0%) 0/21 (0%) 1/55 (1.8%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 1/71 (1.4%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Nervous system disorders
Migraine 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 1/71 (1.4%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Psychiatric disorders
Dissociative disorder 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Reproductive system and breast disorders
Uterine haemorrhage 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Respiratory, thoracic and mediastinal disorders
Respiratory failure 0/49 (0%) 0/21 (0%) 1/55 (1.8%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Surgical and medical procedures
Implantable defibrillator insertion 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 1/71 (1.4%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Vascular disorders
Circulatory collapse 0/49 (0%) 0/21 (0%) 1/55 (1.8%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Other (Not Including Serious) Adverse Events
CP-690,550 1 mg CP-690,550 1 mg to CP-690,550 5 mg (R) CP-690,550 3 mg CP-690,550 3 mg to CP-690,550 5 mg (R) CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg CP-690,550 20 mg CP-690,550 20 mg to CP-690,550 5 mg (R) Placebo Placebo to CP-690,550 5 mg (R)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 28/49 (57.1%) 14/21 (66.7%) 30/55 (54.5%) 10/13 (76.9%) 40/71 (56.3%) 45/74 (60.8%) 46/75 (61.3%) 37/67 (55.2%) 6/13 (46.2%) 29/51 (56.9%) 12/18 (66.7%)
Blood and lymphatic system disorders
Anaemia 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 2/74 (2.7%) 1/75 (1.3%) 1/67 (1.5%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Lymphadenitis 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Neutropenia 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 1/71 (1.4%) 0/74 (0%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Cardiac disorders
Bradycardia 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Extrasystoles 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Palpitations 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 1/71 (1.4%) 0/74 (0%) 0/75 (0%) 1/67 (1.5%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Supraventricular extrasystoles 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 1/18 (5.6%)
Tachycardia 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 1/74 (1.4%) 0/75 (0%) 1/67 (1.5%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Ear and labyrinth disorders
Tinnitus 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 1/71 (1.4%) 2/74 (2.7%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Vertigo 2/49 (4.1%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 1/71 (1.4%) 0/74 (0%) 1/75 (1.3%) 1/67 (1.5%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Eye disorders
Cataract 0/49 (0%) 0/21 (0%) 1/55 (1.8%) 0/13 (0%) 0/71 (0%) 1/74 (1.4%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Conjunctivitis 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 2/71 (2.8%) 1/74 (1.4%) 0/75 (0%) 1/67 (1.5%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Vision blurred 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Visual disturbance 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Xerophthalmia 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 1/74 (1.4%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Gastrointestinal disorders
Abdominal discomfort 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 2/71 (2.8%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Abdominal distension 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Abdominal pain 0/49 (0%) 0/21 (0%) 1/55 (1.8%) 0/13 (0%) 0/71 (0%) 1/74 (1.4%) 1/75 (1.3%) 2/67 (3%) 0/13 (0%) 2/51 (3.9%) 0/18 (0%)
Abdominal pain upper 2/49 (4.1%) 1/21 (4.8%) 2/55 (3.6%) 0/13 (0%) 1/71 (1.4%) 2/74 (2.7%) 1/75 (1.3%) 0/67 (0%) 1/13 (7.7%) 3/51 (5.9%) 1/18 (5.6%)
Abdominal tenderness 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 1/67 (1.5%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Breath odour 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 1/18 (5.6%)
Constipation 0/49 (0%) 1/21 (4.8%) 1/55 (1.8%) 0/13 (0%) 1/71 (1.4%) 2/74 (2.7%) 1/75 (1.3%) 0/67 (0%) 1/13 (7.7%) 1/51 (2%) 0/18 (0%)
Diarrhoea 7/49 (14.3%) 1/21 (4.8%) 1/55 (1.8%) 1/13 (7.7%) 9/71 (12.7%) 1/74 (1.4%) 3/75 (4%) 1/67 (1.5%) 1/13 (7.7%) 2/51 (3.9%) 0/18 (0%)
Dry mouth 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 1/18 (5.6%)
Dyspepsia 1/49 (2%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 3/74 (4.1%) 2/75 (2.7%) 1/67 (1.5%) 0/13 (0%) 1/51 (2%) 2/18 (11.1%)
Flatulence 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 2/74 (2.7%) 0/75 (0%) 0/67 (0%) 1/13 (7.7%) 1/51 (2%) 0/18 (0%)
Gastritis 0/49 (0%) 2/21 (9.5%) 2/55 (3.6%) 0/13 (0%) 1/71 (1.4%) 3/74 (4.1%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 1/18 (5.6%)
Gastrooesophageal reflux disease 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 1/71 (1.4%) 0/74 (0%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Nausea 2/49 (4.1%) 1/21 (4.8%) 3/55 (5.5%) 1/13 (7.7%) 3/71 (4.2%) 5/74 (6.8%) 4/75 (5.3%) 2/67 (3%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Rectal haemorrhage 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 1/67 (1.5%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Stomach discomfort 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 1/71 (1.4%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Toothache 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 1/13 (7.7%) 0/51 (0%) 0/18 (0%)
Vomiting 0/49 (0%) 1/21 (4.8%) 2/55 (3.6%) 1/13 (7.7%) 3/71 (4.2%) 1/74 (1.4%) 2/75 (2.7%) 4/67 (6%) 0/13 (0%) 2/51 (3.9%) 0/18 (0%)
General disorders
Chest discomfort 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Chest pain 0/49 (0%) 0/21 (0%) 2/55 (3.6%) 1/13 (7.7%) 0/71 (0%) 1/74 (1.4%) 1/75 (1.3%) 1/67 (1.5%) 1/13 (7.7%) 0/51 (0%) 0/18 (0%)
Fatigue 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 1/13 (7.7%) 1/71 (1.4%) 2/74 (2.7%) 0/75 (0%) 2/67 (3%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Irritability 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Mucosal inflammation 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Oedema peripheral 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 2/74 (2.7%) 0/75 (0%) 1/67 (1.5%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Pyrexia 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 3/71 (4.2%) 1/74 (1.4%) 0/75 (0%) 2/67 (3%) 0/13 (0%) 1/51 (2%) 1/18 (5.6%)
Immune system disorders
Allergy to arthropod bite 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 1/18 (5.6%)
Infections and infestations
Bronchitis 1/49 (2%) 1/21 (4.8%) 2/55 (3.6%) 0/13 (0%) 1/71 (1.4%) 1/74 (1.4%) 2/75 (2.7%) 1/67 (1.5%) 0/13 (0%) 1/51 (2%) 1/18 (5.6%)
Ear infection 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 1/13 (7.7%) 0/51 (0%) 0/18 (0%)
Erysipelas 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Gastroenteritis 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 2/71 (2.8%) 4/74 (5.4%) 2/75 (2.7%) 1/67 (1.5%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Gastroenteritis viral 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 2/71 (2.8%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Herpes simplex 0/49 (0%) 0/21 (0%) 1/55 (1.8%) 1/13 (7.7%) 0/71 (0%) 0/74 (0%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Herpes zoster 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 1/71 (1.4%) 2/74 (2.7%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Influenza 1/49 (2%) 1/21 (4.8%) 0/55 (0%) 1/13 (7.7%) 2/71 (2.8%) 5/74 (6.8%) 3/75 (4%) 1/67 (1.5%) 1/13 (7.7%) 1/51 (2%) 0/18 (0%)
Laryngitis 0/49 (0%) 0/21 (0%) 1/55 (1.8%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Nasopharyngitis 1/49 (2%) 2/21 (9.5%) 2/55 (3.6%) 1/13 (7.7%) 5/71 (7%) 2/74 (2.7%) 6/75 (8%) 4/67 (6%) 1/13 (7.7%) 3/51 (5.9%) 0/18 (0%)
Onychomycosis 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 1/13 (7.7%) 0/51 (0%) 0/18 (0%)
Oral fungal infection 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 2/75 (2.7%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Oral herpes 0/49 (0%) 2/21 (9.5%) 1/55 (1.8%) 1/13 (7.7%) 1/71 (1.4%) 2/74 (2.7%) 1/75 (1.3%) 1/67 (1.5%) 0/13 (0%) 0/51 (0%) 1/18 (5.6%)
Parainfluenzae virus infection 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Pharyngitis 1/49 (2%) 0/21 (0%) 3/55 (5.5%) 1/13 (7.7%) 2/71 (2.8%) 0/74 (0%) 1/75 (1.3%) 2/67 (3%) 1/13 (7.7%) 2/51 (3.9%) 0/18 (0%)
Pharyngitis streptococcal 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Pharyngotonsillitis 1/49 (2%) 0/21 (0%) 1/55 (1.8%) 0/13 (0%) 2/71 (2.8%) 0/74 (0%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 1/18 (5.6%)
Pulpitis dental 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Rhinitis 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Sinusitis 2/49 (4.1%) 0/21 (0%) 1/55 (1.8%) 0/13 (0%) 0/71 (0%) 3/74 (4.1%) 1/75 (1.3%) 0/67 (0%) 1/13 (7.7%) 0/51 (0%) 0/18 (0%)
Sinusitis bacterial 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 1/18 (5.6%)
Tinea cruris 0/49 (0%) 0/21 (0%) 0/55 (0%) 1/13 (7.7%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Tinea pedis 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 1/74 (1.4%) 0/75 (0%) 1/67 (1.5%) 1/13 (7.7%) 0/51 (0%) 0/18 (0%)
Tonsillitis 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 2/71 (2.8%) 1/74 (1.4%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Tracheitis 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Upper respiratory tract infection 1/49 (2%) 0/21 (0%) 0/55 (0%) 3/13 (23.1%) 5/71 (7%) 5/74 (6.8%) 2/75 (2.7%) 4/67 (6%) 2/13 (15.4%) 1/51 (2%) 2/18 (11.1%)
Urinary tract infection 1/49 (2%) 1/21 (4.8%) 2/55 (3.6%) 2/13 (15.4%) 5/71 (7%) 4/74 (5.4%) 5/75 (6.7%) 6/67 (9%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Viral infection 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 2/71 (2.8%) 1/74 (1.4%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Vulvovaginal mycotic infection 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Injury, poisoning and procedural complications
Animal bite 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Excoriation 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 2/74 (2.7%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 1/18 (5.6%)
Fall 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 1/74 (1.4%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Fibula fracture 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Foot fracture 1/49 (2%) 0/21 (0%) 1/55 (1.8%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Injury 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 1/71 (1.4%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Joint sprain 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Muscle strain 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Investigations
Alanine aminotransferase increased 0/49 (0%) 1/21 (4.8%) 1/55 (1.8%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 5/75 (6.7%) 1/67 (1.5%) 1/13 (7.7%) 1/51 (2%) 0/18 (0%)
Aspartate aminotransferase increased 0/49 (0%) 0/21 (0%) 1/55 (1.8%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 5/75 (6.7%) 2/67 (3%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Blood cholesterol increased 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 1/74 (1.4%) 1/75 (1.3%) 2/67 (3%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Blood creatinine increased 0/49 (0%) 1/21 (4.8%) 1/55 (1.8%) 0/13 (0%) 0/71 (0%) 1/74 (1.4%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Electrocardiogram ST-T change 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Electrocardiogram T wave abnormal 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 1/71 (1.4%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Electrocardiogram abnormal 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 1/13 (7.7%) 0/51 (0%) 0/18 (0%)
Haematocrit decreased 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 1/18 (5.6%)
Haemoglobin decreased 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 1/74 (1.4%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 1/18 (5.6%)
Hepatic enzyme increased 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 2/67 (3%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Transaminases increased 0/49 (0%) 1/21 (4.8%) 1/55 (1.8%) 0/13 (0%) 0/71 (0%) 1/74 (1.4%) 2/75 (2.7%) 2/67 (3%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Weight decreased 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Weight increased 0/49 (0%) 0/21 (0%) 1/55 (1.8%) 1/13 (7.7%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Metabolism and nutrition disorders
Anorexia 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 2/67 (3%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Glucose tolerance impaired 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 1/18 (5.6%)
Hypercholesterolaemia 1/49 (2%) 1/21 (4.8%) 1/55 (1.8%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 4/75 (5.3%) 2/67 (3%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Hyperlipidaemia 1/49 (2%) 0/21 (0%) 1/55 (1.8%) 0/13 (0%) 0/71 (0%) 1/74 (1.4%) 1/75 (1.3%) 1/67 (1.5%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Hypertriglyceridaemia 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 1/71 (1.4%) 1/74 (1.4%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Hyperuricaemia 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 1/18 (5.6%)
Musculoskeletal and connective tissue disorders
Arthralgia 0/49 (0%) 0/21 (0%) 1/55 (1.8%) 2/13 (15.4%) 1/71 (1.4%) 2/74 (2.7%) 2/75 (2.7%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Back pain 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 1/71 (1.4%) 3/74 (4.1%) 1/75 (1.3%) 2/67 (3%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Bone pain 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Fibromyalgia 1/49 (2%) 0/21 (0%) 1/55 (1.8%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Muscle spasms 0/49 (0%) 0/21 (0%) 0/55 (0%) 1/13 (7.7%) 0/71 (0%) 1/74 (1.4%) 0/75 (0%) 1/67 (1.5%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Musculoskeletal chest pain 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 2/71 (2.8%) 0/74 (0%) 0/75 (0%) 1/67 (1.5%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Myalgia 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 1/71 (1.4%) 0/74 (0%) 0/75 (0%) 1/67 (1.5%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Osteochondrosis 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Osteopenia 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 1/18 (5.6%)
Pain in extremity 0/49 (0%) 0/21 (0%) 0/55 (0%) 1/13 (7.7%) 1/71 (1.4%) 0/74 (0%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Rheumatoid arthritis 2/49 (4.1%) 1/21 (4.8%) 0/55 (0%) 1/13 (7.7%) 2/71 (2.8%) 1/74 (1.4%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 1/18 (5.6%)
Synovial cyst 0/49 (0%) 0/21 (0%) 0/55 (0%) 1/13 (7.7%) 1/71 (1.4%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Tendonitis 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 1/71 (1.4%) 0/74 (0%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 1/18 (5.6%)
Nervous system disorders
Burning sensation 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 1/18 (5.6%)
Cluster headache 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Dizziness 0/49 (0%) 0/21 (0%) 1/55 (1.8%) 1/13 (7.7%) 1/71 (1.4%) 3/74 (4.1%) 0/75 (0%) 1/67 (1.5%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Headache 2/49 (4.1%) 1/21 (4.8%) 0/55 (0%) 2/13 (15.4%) 2/71 (2.8%) 3/74 (4.1%) 4/75 (5.3%) 9/67 (13.4%) 3/13 (23.1%) 1/51 (2%) 0/18 (0%)
Hypersomnia 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Hypoaesthesia 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 1/67 (1.5%) 1/13 (7.7%) 0/51 (0%) 0/18 (0%)
Paraesthesia 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 1/74 (1.4%) 0/75 (0%) 0/67 (0%) 1/13 (7.7%) 0/51 (0%) 0/18 (0%)
Sciatica 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 1/71 (1.4%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Sinus headache 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Somnolence 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 2/71 (2.8%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 1/13 (7.7%) 0/51 (0%) 0/18 (0%)
Tension headache 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Psychiatric disorders
Anxiety 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Emotional disorder 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Insomnia 1/49 (2%) 1/21 (4.8%) 1/55 (1.8%) 1/13 (7.7%) 2/71 (2.8%) 2/74 (2.7%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Nervousness 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Nightmare 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Sleep disorder 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Renal and urinary disorders
Leukocyturia 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Nephrolithiasis 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 1/74 (1.4%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Pyuria 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Reproductive system and breast disorders
Genital discharge 0/49 (0%) 0/21 (0%) 0/55 (0%) 1/13 (7.7%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Ovarian cyst 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 1/74 (1.4%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Asthma 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Cough 1/49 (2%) 0/21 (0%) 2/55 (3.6%) 0/13 (0%) 3/71 (4.2%) 6/74 (8.1%) 2/75 (2.7%) 2/67 (3%) 1/13 (7.7%) 0/51 (0%) 0/18 (0%)
Dyspnoea 0/49 (0%) 0/21 (0%) 1/55 (1.8%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Epistaxis 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Nasal congestion 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 1/71 (1.4%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Nasal mucosal disorder 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 1/74 (1.4%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Pharyngeal inflammation 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Pharyngolaryngeal pain 1/49 (2%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 1/71 (1.4%) 0/74 (0%) 0/75 (0%) 1/67 (1.5%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Pulmonary congestion 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 1/74 (1.4%) 0/75 (0%) 2/67 (3%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Respiratory disorder 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 1/75 (1.3%) 1/67 (1.5%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Rhinitis allergic 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Rhinorrhoea 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Sinus congestion 0/49 (0%) 0/21 (0%) 1/55 (1.8%) 1/13 (7.7%) 0/71 (0%) 1/74 (1.4%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Wheezing 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 1/74 (1.4%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 1/18 (5.6%)
Skin and subcutaneous tissue disorders
Acne 0/49 (0%) 0/21 (0%) 0/55 (0%) 1/13 (7.7%) 0/71 (0%) 1/74 (1.4%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Alopecia 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 1/74 (1.4%) 0/75 (0%) 1/67 (1.5%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Angioedema 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Dermatitis 0/49 (0%) 0/21 (0%) 1/55 (1.8%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Ecchymosis 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 1/74 (1.4%) 0/75 (0%) 1/67 (1.5%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Eczema 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 1/71 (1.4%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Erythema 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 1/13 (7.7%) 0/51 (0%) 0/18 (0%)
Intertrigo 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Palpable purpura 0/49 (0%) 1/21 (4.8%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Pruritus 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Rash 1/49 (2%) 0/21 (0%) 2/55 (3.6%) 0/13 (0%) 2/71 (2.8%) 4/74 (5.4%) 2/75 (2.7%) 1/67 (1.5%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Rash generalised 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)
Rash papular 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Urticaria 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Vascular disorders
Hot flush 1/49 (2%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 1/71 (1.4%) 0/74 (0%) 1/75 (1.3%) 0/67 (0%) 0/13 (0%) 0/51 (0%) 0/18 (0%)
Hypertension 2/49 (4.1%) 1/21 (4.8%) 2/55 (3.6%) 0/13 (0%) 1/71 (1.4%) 2/74 (2.7%) 2/75 (2.7%) 2/67 (3%) 0/13 (0%) 0/51 (0%) 1/18 (5.6%)
Venous stasis 0/49 (0%) 0/21 (0%) 0/55 (0%) 0/13 (0%) 0/71 (0%) 0/74 (0%) 0/75 (0%) 0/67 (0%) 0/13 (0%) 1/51 (2%) 0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

Name/Title Pfizer ClinicalTrials.gov Call Center
Organization Pfizer, Inc.
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00413660
Other Study ID Numbers:
  • A3921025
First Posted:
Dec 20, 2006
Last Update Posted:
Jan 18, 2013
Last Verified:
Jan 1, 2013