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Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis in Japan

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00603512
Collaborator
(none)
140
Enrollment
18
Locations
5
Arms
8
Duration (Months)
7.8
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effectiveness and safety, over 3 months, of 4 dose regimens of CP-690,550, combined with methotrexate, for the treatment with active rheumatoid arthritis.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Confirm Dose Responsiveness Following 12 Weeks of the Administration of CP-690,550 (4 Doses) or Placebo in Subjects With Active Rheumatoid Arthritis Inadequately Controlled With Methotrexate Alone
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: CP-690,550, 0mg

Drug: Placebo
0 mg BID, 3 blinded tablets administered BID for 12 weeks
Experimental: CP-690,550, 10mg

Drug: CP-690,550
10 mg BID, 3 blinded tablets administered BID for 12 weeks
Experimental: CP-690,550, 1mg

Drug: CP-690,550
1 mg BID, 3 blinded tablets administered BID for 12 weeks
Experimental: CP-690,550, 3mg

Drug: CP-690,550
3 mg BID, 3 blinded tablets administered BID for 12 weeks
Experimental: CP-690,550, 5mg

Drug: CP-690,550
5 mg BID, 3 blinded tablets administered BID for 12 weeks

Outcome Measures

Primary Outcome Measures

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

    ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint 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 1, 2, 4, 8]

    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 1, 2, 4, 8, 12/End of Treatment (EOT)]

    ACR50 response: >= 50% improvement in tender or swollen joint counts 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 1, 2, 4, 8, 12/EOT]

    ACR70 response: >= 70% improvement in tender or swollen joint counts 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. Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response [Week 1, 2, 4, 8, 12/EOT]

    ACR90 response: >= 90% improvement in tender or swollen joint counts and 90% 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.

  5. Tender Joint Count (TJC) [Baseline, Week 1, 2, 4, 8, 12/EOT]

    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 Joint Count (TJC) at Week 1, 2, 4, 8 and 12/EOT [Baseline, Week 1, 2, 4, 8, 12/EOT]

    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 Joint Count (SJC) [Baseline, Week 1, 2, 4, 8, 12/EOT]

    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 Joint Count (SJC) at Week 1, 2, 4, 8 and 12/EOT [Baseline, Week 1, 2, 4, 8, 12/EOT]

    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 1, 2, 4, 8, 12/EOT]

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

  10. Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12/EOT [Baseline, Week 1, 2, 4, 8, 12/EOT]

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

  11. Patient Global Assessment (PtGA) of Arthritis [Baseline, Week 1, 2, 4, 8, 12/EOT]

    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 = very well and 100 = very poorly.

  12. Change From Baseline in Patient Global Assessment of Arthritis (PtGA) at Week 1, 2, 4, 8 and 12/EOT [Baseline, Week 1, 2, 4, 8, 12/EOT]

    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 = very well and 100 = very poorly.

  13. Physician Global Assessment (PGA) of Arthritis [Baseline, Week 1, 2, 4, 8, 12/EOT]

    Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 = very good and 100 = very bad.

  14. Change From Baseline in Physician Global Assessment of Arthritis (PGA) at Week 1, 2, 4, 8 and 12/EOT [Baseline, Week 1, 2, 4, 8, 12/EOT]

    Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 = very good and 100 = very bad.

  15. Health Assessment Questionnaire-Disability Index (HAQ-DI) [Baseline, Week 1, 2, 4, 8, 12/EOT]

    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 1, 2, 4, 8 and 12/EOT [Baseline, Week 1, 2, 4, 8, 12/EOT]

    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.

  17. C-Reactive Protein (CRP) [Baseline, Week 1, 2, 4, 8, 12/EOT]

    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 liter (mg/L) to 10 mg/L. 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 1, 2, 4, 8 and 12/EOT [Baseline, Week 1, 2, 4, 8, 12/EOT]

    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 liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

  19. Numeric Index of American College of Rheumatology Response (ACR-n) [Week 1, 2, 4, 8, 12/EOT]

    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.

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

    ACR-n = calculated for each participant by taking lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of remaining 5 components of 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 AUC for ACR-n is measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute AUC.

  21. Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) [Baseline, Week 1, 2, 4, 8, 12/EOT]

    DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint 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, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.

  22. Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) [Baseline, Week 1, 2, 4, 8, 12/EOT]

    DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission.

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

    SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

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

    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, selfcare, 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.

  25. Medical Outcome Study- Sleep Scale (MOS-SS) [Baseline, Week 2, 12/EOT]

    Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales:sleep disturbance(SD),snoring(Sno),awakened short of breath(ASOB),sleep adequacy(Ade),somnolence(Som)(range:0-100);sleep quantity(Qua)(range:0-24),optimal(Opt) sleep(yes:1,no:0),9 item index measures of sleep disturbance provide composite scores:sleep problem summary(SPS),overall SP(OSP).Except Ade,Opt,Qua,higher scores=more impairment.Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.

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

    FACIT-F 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-Fatigue 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:
20 Years to 70 Years
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 Hitachi-shi Ibaraki Japan
2 Pfizer Investigational Site Sagamihara Kanagawa Japan
3 Pfizer Investigational Site Yahatanishi-ku Kitakyusyu Japan
4 Pfizer Investigational Site Koushi Kumamoto Japan
5 Pfizer Investigational Site Sendai Miyagi Japan
6 Pfizer Investigational Site Kawachinagano Osaka Japan
7 Pfizer Investigational Site Kawagoe-shi Saitama Japan
8 Pfizer Investigational Site Kitamoto Saitama Japan
9 Pfizer Investigational Site Bunkyo-ku Tokyo Japan
10 Pfizer Investigational Site Bunkyo-k Tokyo Japan
11 Pfizer Investigational Site Chiyoda-ku Tokyo Japan
12 Pfizer Investigational Site Koto-ku Tokyo Japan
13 Pfizer Investigational Site Meguro-ku Tokyo Japan
14 Pfizer Investigational Site Musashimurayama-shi Tokyo Japan
15 Pfizer Investigational Site Shinjyuku-ku Tokyo Japan
16 Pfizer Investigational Site Chiba Japan
17 Pfizer Investigational Site Fukuoka Japan
18 Pfizer Investigational Site Niigata Japan

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:
NCT00603512
Other Study ID Numbers:
  • A3921039
First Posted:
Jan 29, 2008
Last Update Posted:
Jan 25, 2013
Last Verified:
Dec 1, 2012
Keywords provided by Pfizer
Phase II MTX add-on study in Japan
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 Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Period Title: Overall Study
STARTED 28 28 28 28 28
Treated 28 27 27 26 28
COMPLETED 26 23 23 21 23
NOT COMPLETED 2 5 5 7 5

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 Placebo Total
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks. Total of all reporting groups
Overall Participants 28 27 27 26 28 136
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
52.0
(9.4)
53.3
(12.1)
50.0
(9.8)
50.6
(10.0)
50.6
(12.4)
51.3
(10.7)
Sex: Female, Male (Count of Participants)
Female
21
75%
24
88.9%
22
81.5%
25
96.2%
25
89.3%
117
86%
Male
7
25%
3
11.1%
5
18.5%
1
3.8%
3
10.7%
19
14%

Outcome Measures

1. Primary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Description ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint 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 medication. Missing values were imputed using Last observation carried forward (LOCF) method.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Number [Percentage of Participants]
64.3
229.6%
77.8
288.1%
96.3
356.7%
80.8
310.8%
14.3
51.1%
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 1, 2, 4, 8

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Week 1
28.57
102%
14.81
54.9%
29.63
109.7%
38.46
147.9%
3.57
12.8%
Week 2
32.14
114.8%
40.74
150.9%
62.96
233.2%
50.00
192.3%
10.71
38.3%
Week 4
50.00
178.6%
55.56
205.8%
88.89
329.2%
76.92
295.8%
10.71
38.3%
Week 8
67.86
242.4%
66.67
246.9%
96.30
356.7%
80.77
310.7%
21.43
76.5%
3. Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Description ACR50 response: >= 50% improvement in tender or swollen joint counts 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 1, 2, 4, 8, 12/End of Treatment (EOT)

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Week 1
7.14
25.5%
3.70
13.7%
0.00
0%
7.69
29.6%
0.00
0%
Week 2
7.14
25.5%
7.41
27.4%
25.93
96%
26.92
103.5%
0.00
0%
Week 4
10.71
38.3%
22.22
82.3%
29.63
109.7%
34.62
133.2%
3.57
12.8%
Week 8
28.57
102%
29.63
109.7%
70.37
260.6%
50.00
192.3%
7.14
25.5%
Week 12
32.14
114.8%
44.44
164.6%
81.48
301.8%
57.69
221.9%
14.29
51%
4. Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Description ACR70 response: >= 70% improvement in tender or swollen joint counts 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 1, 2, 4, 8, 12/EOT

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Week 1
0.00
0%
0.00
0%
0.00
0%
3.85
14.8%
0.00
0%
Week 2
0.00
0%
3.70
13.7%
11.11
41.1%
3.85
14.8%
0.00
0%
Week 4
3.57
12.8%
7.41
27.4%
14.81
54.9%
7.69
29.6%
0.00
0%
Week 8
3.57
12.8%
7.41
27.4%
33.33
123.4%
26.92
103.5%
3.57
12.8%
Week 12
7.14
25.5%
14.81
54.9%
33.33
123.4%
34.62
133.2%
3.57
12.8%
5. Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response
Description ACR90 response: >= 90% improvement in tender or swollen joint counts and 90% 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 1, 2, 4, 8, 12/EOT

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Week 1
0.00
0%
0.00
0%
0.00
0%
0.00
0%
0.00
0%
Week 2
0.00
0%
0.00
0%
0.00
0%
3.85
14.8%
0.00
0%
Week 4
0.00
0%
0.00
0%
3.70
13.7%
0.00
0%
0.00
0%
Week 8
0.00
0%
3.70
13.7%
7.41
27.4%
3.85
14.8%
0.00
0%
Week 12
0.00
0%
11.11
41.1%
3.70
13.7%
11.54
44.4%
0.00
0%
6. Secondary Outcome
Title Tender Joint 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 1, 2, 4, 8, 12/EOT

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Baseline (n=28,27,27,26,28)
16.36
(7.56)
16.22
(8.50)
17.81
(12.32)
15.42
(9.77)
16.36
(9.08)
Week 1 (n=28,26,27,26,28)
11.89
(7.06)
12.04
(10.95)
13.22
(14.04)
10.96
(11.89)
12.86
(9.03)
Week 2 (n=27,27,27,25,26)
11.63
(8.72)
9.63
(8.72)
9.52
(13.12)
8.20
(10.91)
11.62
(9.43)
Week 4 (n=27,26,27,24,25)
10.04
(7.64)
7.00
(7.61)
8.22
(10.48)
5.58
(6.35)
13.76
(11.30)
Week 8 (n=26,25,26,23,24)
6.73
(6.80)
5.40
(7.64)
5.15
(6.49)
3.35
(4.71)
11.04
(8.38)
Week 12 (n=26,24,24,21,24)
5.92
(6.73)
6.38
(9.60)
3.63
(4.39)
2.71
(4.33)
9.96
(7.85)
7. Secondary Outcome
Title Change From Baseline in Tender Joint Count (TJC) at Week 1, 2, 4, 8 and 12/EOT
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 1, 2, 4, 8, 12/EOT

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Week 1 (n=28,26,27,26,28)
-4.46
(4.80)
-4.19
(6.92)
-4.59
(5.76)
-4.46
(7.61)
-3.50
(5.68)
Week 2 (n=27,27,27,25,26)
-4.70
(7.37)
-6.59
(7.31)
-8.30
(6.36)
-6.88
(6.09)
-4.54
(5.48)
Week 4 (n=27,26,27,24,25)
-6.30
(8.78)
-9.00
(8.94)
-9.59
(7.00)
-9.88
(7.50)
-2.28
(8.38)
Week 8 (n=26,25,26,23,24)
-9.42
(8.90)
-10.84
(9.00)
-12.88
(10.77)
-12.09
(8.23)
-4.04
(7.17)
Week 12 (n=26,24,24,21,24)
-10.23
(8.84)
-9.96
(10.79)
-14.42
(10.43)
-12.71
(8.01)
-5.13
(7.27)
8. Secondary Outcome
Title Swollen Joint 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 1, 2, 4, 8, 12/EOT

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Baseline (n=28,27,27,26,28)
13.18
(5.63)
15.11
(7.92)
15.59
(12.41)
15.12
(9.96)
13.82
(6.27)
Week 1 (n=28,26,27,26,28)
10.07
(5.87)
12.62
(9.21)
12.70
(12.66)
9.73
(10.98)
13.18
(7.45)
Week 2 (n=27,27,27,25,26)
8.26
(4.81)
9.67
(6.23)
9.41
(11.52)
8.04
(11.36)
12.04
(6.95)
Week 4 (n=27,26,27,24,25)
7.85
(6.00)
8.19
(6.50)
7.41
(9.28)
6.63
(7.83)
11.80
(7.88)
Week 8 (n=26,25,26,23,24)
5.92
(4.86)
6.12
(5.40)
4.62
(4.99)
5.17
(6.31)
11.08
(8.10)
Week 12 (n=26,24,24,21,24)
5.19
(5.87)
5.29
(5.43)
3.83
(4.24)
4.05
(5.98)
11.13
(7.12)
9. Secondary Outcome
Title Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12/EOT
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 1, 2, 4, 8, 12/EOT

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Week 1 (n=28,26,27,26,28)
-3.11
(5.26)
-2.54
(6.11)
-2.89
(2.81)
-5.38
(5.08)
-0.64
(3.71)
Week 2 (n=27,27,27,25,26)
-4.74
(5.45)
-5.44
(6.57)
-6.19
(5.02)
-6.84
(4.87)
-1.69
(3.48)
Week 4 (n=27,26,27,24,25)
-5.15
(7.25)
-6.69
(7.07)
-8.19
(5.94)
-8.50
(5.16)
-1.68
(4.59)
Week 8 (n=26,25,26,23,24)
-6.92
(6.56)
-8.96
(8.25)
-11.35
(8.91)
-10.09
(6.08)
-2.08
(6.55)
Week 12 (n=26,24,24,21,24)
-7.65
(7.53)
-9.71
(8.16)
-12.58
(10.06)
-11.71
(6.68)
-2.04
(5.77)
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 = no pain and 100 = most severe pain.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Baseline (n=28,26,27,26,28)
54.18
(23.48)
57.59
(20.18)
53.22
(25.94)
52.19
(24.97)
53.32
(23.63)
Week 1 (n=28,26,27,26,28)
45.36
(20.32)
43.50
(20.69)
40.19
(24.03)
37.08
(23.38)
49.36
(24.42)
Week 2 (n=27,27,27,25,26)
45.11
(20.11)
40.52
(24.32)
33.19
(24.63)
31.40
(20.92)
48.58
(25.56)
Week 4 (n=27,26,27,25,26)
42.44
(20.98)
34.88
(22.45)
25.19
(20.67)
30.46
(23.60)
49.72
(24.46)
Week 8 (n=26,25,27,23,24)
32.65
(17.84)
30.04
(23.37)
22.59
(21.45)
19.43
(18.64)
48.88
(23.01)
Week 12 (n=26,24,24,21,24)
32.19
(17.69)
27.17
(21.40)
17.58
(17.27)
16.90
(20.29)
44.96
(25.41)
11. Secondary Outcome
Title Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12/EOT
Description Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 = no pain and 100 = most severe pain.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Week 1 (n=28,26,27,26,28)
-8.82
(18.21)
-14.35
(16.99)
-13.04
(18.78)
-15.12
(19.89)
-3.96
(14.90)
Week 2 n=27,27,27,25,26)
-10.41
(20.16)
-17.07
(25.47)
-20.04
(22.04)
-22.44
(27.77)
-3.69
(10.60)
Week 4 (n=27,26,27,24,25)
-13.07
(23.22)
-23.35
(22.89)
-28.04
(23.74)
-24.29
(26.28)
-1.00
(14.27)
Week 8 (n=26,25,27,23,24)
-22.54
(26.84)
-28.92
(23.46)
-30.63
(25.40)
-34.26
(26.19)
-2.04
(22.66)
Week 12 (n=26,24,24,21,24)
-23.00
(25.13)
-32.50
(22.75)
-31.38
(22.67)
-38.43
(28.38)
-5.96
(22.61)
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 = very well and 100 = very poorly.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Baseline (n=28,27,27,26,28)
58.00
(18.27)
60.26
(21.79)
58.67
(23.63)
52.04
(26.27)
53.50
(24.04)
Week 1 (n=28,26,27,26,28)
45.89
(21.08)
44.27
(19.25)
42.56
(24.48)
34.73
(21.41)
46.54
(23.49)
Week 2 (n=27,27,27,25,26)
46.07
(22.39)
42.63
(23.82)
33.78
(25.04)
30.44
(20.57)
48.42
(25.65)
Week 4 (n=27,26,27,24,25)
44.59
(22.89)
34.23
(21.81)
28.93
(21.61)
30.04
(22.62)
49.16
(25.09)
Week 8 (n=26,25,27,23,24)
35.12
(17.80)
30.68
(24.36)
21.81
(22.22)
20.39
(20.85)
49.17
(22.00)
Week 12 (n=26,24,24,21,24)
31.42
(17.08)
24.21
(19.82)
17.13
(16.00)
16.48
(18.62)
43.75
(24.60)
13. Secondary Outcome
Title Change From Baseline in Patient Global Assessment of Arthritis (PtGA) at Week 1, 2, 4, 8 and 12/EOT
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 = very well and 100 = very poorly.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Week 1 (n=28,26,27,26,28)
-12.11
(17.07)
-16.92
(17.48)
-16.11
(20.72)
-17.31
(20.45)
-6.96
(15.78)
Week 2 (n=27,27,27,25,26)
-12.19
(18.44)
-17.63
(25.30)
-24.89
(21.03)
-23.40
(28.28)
-3.69
(12.29)
Week 4 (n=27,26,27,24,25)
-13.67
(20.21)
-27.50
(21.80)
-29.74
(21.90)
-24.50
(26.24)
-1.40
(14.92)
Week 8 (n=26,25,27,23,24)
-22.85
(25.79)
-32.04
(22.17)
-36.85
(22.07)
-33.09
(27.70)
-1.46
(23.75)
Week 12 (n=26,24,24,21,24)
-26.54
(24.18)
-38.00
(21.09)
-37.46
(19.91)
-38.33
(29.46)
-6.88
(21.45)
14. Secondary Outcome
Title Physician Global Assessment (PGA) of Arthritis
Description Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 = very good and 100 = very bad.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Baseline (n=28,27,27,26,28)
66.00
(16.32)
61.44
(19.18)
59.37
(17.67)
59.04
(18.00)
59.39
(19.88)
Week 1 (n=28,26,27,26,28)
49.96
(17.44)
47.96
(19.95)
45.26
(21.43)
36.12
(19.45)
50.64
(22.39)
Week 2 (n=27,27,27,25,26)
44.04
(18.74)
42.52
(23.78)
34.59
(22.64)
28.84
(18.90)
44.62
(22.26)
Week 4 (n=27,26,27,24,25)
41.30
(20.94)
33.04
(18.66)
24.67
(17.67)
23.92
(16.60)
47.96
(23.20)
Week 8 (n=26,25,26,23,24)
29.65
(15.94)
26.08
(18.70)
17.46
(14.83)
16.57
(13.62)
40.21
(21.40)
Week 12 (n=26,24,24,21,24)
26.31
(20.39)
23.38
(17.00)
13.71
(10.58)
14.86
(12.28)
40.92
(21.69)
15. Secondary Outcome
Title Change From Baseline in Physician Global Assessment of Arthritis (PGA) at Week 1, 2, 4, 8 and 12/EOT
Description Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 = very good and 100 = very bad.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Week 1 (n=28,26,27,26,28)
-16.04
(15.29)
-14.12
(13.11)
-14.11
(12.67)
-22.92
(21.00)
-8.75
(15.39)
Week 2 (n=27,27,27,25,26)
-22.33
(18.70)
-18.93
(18.12)
-24.78
(16.65)
-30.16
(20.74)
-13.69
(18.05)
Week 4 (n=27,26,27,24,25)
-25.07
(25.23)
-28.23
(17.91)
-34.70
(18.49)
-34.83
(19.77)
-9.36
(20.67)
Week 8 (n=26,25,26,23,24)
-35.88
(23.06)
-35.72
(15.68)
-41.46
(17.19)
-42.17
(19.26)
-16.63
(23.24)
Week 12 (n=26,24,24,21,24)
-39.23
(27.72)
-36.92
(17.53)
-44.71
(15.94)
-45.05
(20.37)
-15.92
(24.95)
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 1, 2, 4, 8, 12/EOT

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Baseline (n=28,27,27,26,28)
1.14
(0.74)
1.29
(0.64)
1.17
(0.60)
1.16
(0.58)
1.25
(0.70)
Week 1 (n=28,26,27,26,28)
1.05
(0.75)
1.23
(0.66)
1.05
(0.54)
0.85
(0.54)
1.25
(0.74)
Week 2 (n=27,27,27,25,26)
1.04
(0.72)
1.12
(0.66)
0.88
(0.56)
0.79
(0.50)
1.18
(0.76)
Week 4 (n=27,26,27,24,25)
0.94
(0.74)
1.04
(0.75)
0.79
(0.55)
0.77
(0.58)
1.07
(0.70)
Week 8 (n=26,25,27,23,24)
0.80
(0.69)
0.96
(0.78)
0.72
(0.54)
0.64
(0.53)
1.21
(0.80)
Week 12 (n=26,24,24,21,24)
0.78
(0.70)
0.81
(0.73)
0.56
(0.41)
0.59
(0.54)
1.13
(0.79)
17. Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 8 and 12/EOT
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 1, 2, 4, 8, 12/EOT

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Week 1 (n=28,26,27,26,28)
-0.08
(0.29)
-0.11
(0.37)
-0.12
(0.18)
-0.31
(0.39)
-0.00
(0.19)
Week 2 (n=27,27,27,25,26)
-0.13
(0.35)
-0.17
(0.39)
-0.29
(0.32)
-0.39
(0.38)
-0.02
(0.26)
Week 4 (n=27,26,27,24,25)
-0.22
(0.48)
-0.25
(0.47)
-0.38
(0.30)
-0.43
(0.42)
-0.10
(0.26)
Week 8 (n=26,25,27,23,24)
-0.36
(0.58)
-0.32
(0.49)
-0.45
(0.31)
-0.52
(0.44)
0.03
(0.40)
Week 12 (n=26,24,24,21,24)
-0.38
(0.55)
-0.41
(0.46)
-0.49
(0.35)
-0.57
(0.46)
-0.05
(0.43)
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 liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Baseline (n=28,27,27,26,28)
26.71
(31.02)
27.63
(26.00)
16.59
(16.15)
20.03
(21.22)
22.25
(25.05)
Week 1 (n=28,26,27,26,28)
15.45
(21.23)
13.22
(16.89)
4.52
(6.49)
3.29
(4.91)
20.63
(22.24)
Week 2 (n=27,27,27,25,26)
15.79
(20.73)
10.34
(14.03)
3.16
(5.37)
2.15
(3.43)
18.12
(21.97)
Week 4 (n=27,26,27,24,25)
14.33
(21.04)
9.59
(14.22)
2.35
(3.36)
2.40
(5.13)
17.24
(18.87)
Week 8 (n=26,25,27,23,24)
13.82
(22.16)
4.19
(5.31)
4.18
(12.36)
10.72
(23.02)
15.29
(16.50)
Week 12 (n=26,24,24,21,24)
12.04
(21.23)
8.78
(17.44)
2.98
(8.72)
7.00
(16.05)
17.37
(25.30)
19. Secondary Outcome
Title Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12/EOT
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 liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Week 1 (n=28,26,27,26,28)
-11.26
(14.29)
-15.37
(20.41)
-12.07
(11.50)
-16.75
(19.28)
-1.62
(11.47)
Week 2 (n=27,27,27,25,26)
-11.83
(16.03)
-17.29
(20.63)
-13.43
(12.71)
-18.54
(21.03)
-2.38
(16.85)
Week 4 (n=27,26,27,24,25)
-13.29
(20.00)
-18.35
(22.09)
-14.24
(13.90)
-17.31
(21.16)
-3.26
(16.48)
Week 8 (n=26,25,27,23,24)
-14.66
(22.72)
-22.90
(24.20)
-12.41
(16.40)
-9.19
(23.29)
-5.83
(16.73)
Week 12 (n=26,24,24,21,24)
-16.43
(27.15)
-17.89
(28.20)
-10.49
(14.72)
-14.10
(22.34)
-3.75
(19.97)
20. Secondary Outcome
Title Numeric Index of American College of Rheumatology Response (ACR-n)
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.
Time Frame Week 1, 2, 4, 8, 12/EOT

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Week 1
4.80
(32.73)
6.06
(20.00)
10.60
(19.13)
10.73
(42.87)
-11.08
(21.61)
Week 2
8.74
(28.66)
17.43
(25.30)
30.61
(26.21)
25.15
(28.64)
-8.84
(26.69)
Week 4
14.67
(38.45)
23.83
(32.99)
40.88
(26.07)
37.08
(25.42)
-23.54
(51.98)
Week 8
30.40
(33.10)
31.64
(33.87)
56.76
(24.53)
45.62
(29.46)
-18.74
(62.37)
Week 12
30.26
(35.83)
34.64
(48.37)
60.16
(24.26)
52.08
(32.22)
-11.19
(38.76)
21. 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 lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of remaining 5 components of 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 AUC for ACR-n is measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute AUC.
Time Frame Baseline up to Week 12

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Mean (Standard Deviation) [units on a scale*weeks]
1708.31
(2458.38)
2096.79
(2355.96)
3685.71
(1721.44)
3124.40
(2011.19)
-1346.24
(2995.11)
22. 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 SJC and TJC using 28 joint 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, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Baseline (n=28,27,27,26,28)
5.03
(0.68)
5.13
(0.94)
5.00
(0.96)
4.94
(1.01)
4.90
(0.87)
Week 1 (n=28,26,27,26,28)
4.30
(0.86)
4.30
(1.10)
4.09
(1.28)
3.74
(0.93)
4.61
(1.08)
Week 2 (n=27,27,27,25,26)
4.23
(0.95)
3.95
(1.18)
3.46
(1.25)
3.25
(1.01)
4.43
(1.11)
Week 4 (n=27,26,27,24,25)
3.96
(1.13)
3.63
(1.05)
3.21
(1.27)
2.80
(0.94)
4.56
(1.15)
Week 8 (n=26,25,26,23,24)
3.43
(1.03)
3.03
(1.10)
2.77
(0.97)
2.52
(0.96)
4.31
(1.21)
Week 12 (n=26,24,24,21,24)
3.21
(1.05)
3.14
(1.27)
2.55
(0.90)
2.14
(0.61)
4.15
(1.36)
23. Secondary Outcome
Title Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
Description DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Baseline (n=28,27,27,26,28)
6.11
(0.79)
6.06
(1.04)
6.02
(1.03)
5.86
(0.95)
5.86
(0.96)
Week 1 (n=28,26,27,26,28)
5.42
(0.98)
5.33
(1.22)
5.09
(1.34)
4.88
(1.08)
5.46
(1.11)
Week 2 (n=27,27,27,25,26)
5.29
(1.07)
5.03
(1.36)
4.48
(1.37)
4.28
(1.04)
5.34
(1.24)
Week 4 (n=27,26,27,24,25)
5.00
(1.04)
4.54
(1.29)
4.03
(1.43)
3.72
(1.13)
5.49
(1.29)
Week 8 (n=26,25,26,23,24)
4.37
(1.05)
4.00
(1.34)
3.49
(1.21)
3.13
(1.12)
5.22
(1.42)
Week 12 (n=26,24,24,21,24)
4.07
(0.99)
3.90
(1.36)
3.13
(0.99)
2.83
(0.99)
5.07
(1.47)
24. Secondary Outcome
Title 36-Item Short-Form Health Survey (SF-36)
Description SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. 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/EOT

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Baseline:Physical functioning (n=28,27,27,26,28)
37.87
(9.10)
37.94
(9.37)
38.87
(10.41)
40.93
(9.47)
38.69
(9.80)
Baseline:Role Physical (n=28,27,27,26,28)
39.27
(11.83)
41.43
(13.22)
44.25
(10.25)
45.64
(13.33)
42.77
(11.69)
Baseline:Bodily Pain (n=28,27,27,26,28)
37.27
(7.89)
36.89
(7.53)
38.59
(8.44)
40.58
(7.00)
36.81
(9.61)
Baseline:General Health (n=28,27,27,26,28)
37.54
(6.14)
37.56
(7.53)
37.57
(10.16)
38.87
(8.25)
37.42
(7.00)
Baseline:Vitality (n=28,27,27,26,28)
45.07
(11.58)
46.31
(10.49)
46.19
(11.13)
46.69
(9.86)
46.96
(9.58)
Baseline:Social Functioning (n=28,27,27,26,28)
46.72
(13.5)
42.71
(13.21)
45.54
(10.47)
46.78
(11.82)
45.16
(12.74)
Baseline:Role-Emotional (n=28,27,27,26,28)
40.61
(13.00)
41.05
(13.47)
45.37
(10.33)
45.11
(14.93)
44.91
(13.13)
Baseline:Mental Health (n=28,27,27,26,28)
43.07
(10.15)
44.27
(9.12)
43.65
(10.11)
46.97
(10.98)
45.08
(11.81)
Baseline:Physical Component (n=28,27,27,26,28)
37.16
(7.71)
37.54
(7.92)
38.75
(8.59)
40.39
(7.02)
37.35
(8.56)
Baseline:Mental Component (n=28,27,27,26,28)
46.06
(12.16)
45.81
(11.86)
47.38
(9.60)
48.48
(11.72)
48.36
(12.08)
Week 12:Physical functioning (n=26,24,24,21,24)
42.71
(10.07)
43.27
(9.69)
46.42
(9.00)
47.51
(9.86)
40.72
(9.40)
Week 12:Role Physical (n=26,24,24,21,24)
44.61
(10.39)
46.96
(10.60)
50.73
(7.19)
50.32
(9.37)
44.81
(10.21)
Week 12:Bodily Pain (n=26,24,24,21,24)
42.81
(7.05)
44.58
(8.93)
48.70
(7.20)
49.94
(8.45)
39.77
(7.98)
Week 12:General Health (n=26,24,24,21,24)
42.08
(7.07)
43.14
(8.63)
45.03
(7.76)
45.19
(8.06)
37.78
(8.03)
Week 12:Vitality (n=26,24,24,21,24)
50.53
(10.27)
49.88
(11.52)
53.65
(11.24)
52.24
(11.53)
48.71
(11.20)
Week 12:Social Functioning (n=26,24,24,21,24)
48.46
(10.37)
46.62
(12.49)
51.85
(7.36)
52.43
(8.20)
47.99
(12.12)
Week 12:Role-Emotional (n=26,24,24,21,24)
47.51
(8.64)
46.16
(12.08)
47.78
(10.12)
48.47
(9.83)
44.70
(12.15)
Week 12:Mental Health (n=26,24,24,21,24)
50.22
(7.96)
47.90
(11.87)
51.53
(7.33)
49.07
(12.51)
46.25
(13.81)
Week 12:Physical Component (n=26,24,24,21,24)
41.21
(9.42)
43.87
(7.75)
47.27
(6.61)
48.39
(7.18)
39.77
(6.59)
Week 12:Mental Component (n=26,24,24,21,24)
51.90
(8.68)
48.93
(13.44)
52.07
(8.99)
50.68
(10.10)
49.00
(13.09)
25. Secondary Outcome
Title Euro Quality of Life (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, selfcare, 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/EOT

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Baseline (n=28,27,27,26,28)
0.55
(0.26)
0.45
(0.29)
0.58
(0.24)
0.55
(0.32)
0.51
(0.33)
Week 12 (n=26,24,24,21,24)
0.65
(0.23)
0.70
(0.27)
0.79
(0.13)
0.78
(0.28)
0.59
(0.27)
26. Secondary Outcome
Title Medical Outcome Study- Sleep Scale (MOS-SS)
Description Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales:sleep disturbance(SD),snoring(Sno),awakened short of breath(ASOB),sleep adequacy(Ade),somnolence(Som)(range:0-100);sleep quantity(Qua)(range:0-24),optimal(Opt) sleep(yes:1,no:0),9 item index measures of sleep disturbance provide composite scores:sleep problem summary(SPS),overall SP(OSP).Except Ade,Opt,Qua,higher scores=more impairment.Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.
Time Frame Baseline, Week 2, 12/EOT

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Baseline: SPS (n=28,27,27,26,28)
27.38
(11.42)
27.41
(14.36)
29.38
(17.54)
30.51
(18.78)
23.93
(12.57)
Baseline: OSP (n=28,27,27,26,28)
28.00
(10.53)
27.55
(12.40)
31.07
(17.38)
31.28
(18.60)
25.95
(12.89)
Baseline: Ade (n=28,27,27,26,28)
52.86
(24.47)
52.96
(24.93)
49.63
(27.80)
51.54
(26.64)
58.57
(27.98)
Baseline: ASOB (n=28,27,27,26,28)
3.57
(9.51)
4.44
(10.13)
8.15
(22.37)
10.00
(14.14)
3.57
(7.80)
Baseline: SD (n=28,27,27,26,28)
24.06
(17.70)
23.84
(21.10)
25.28
(20.95)
25.77
(21.45)
21.43
(16.66)
Baseline: Opt (n=28,27,27,26,28)
0.61
(0.50)
0.30
(0.47)
0.41
(0.50)
0.42
(0.50)
0.39
(0.50)
Baseline: Qua (n=28,27,27,26,28)
6.61
(1.10)
6.37
(1.45)
6.30
(0.87)
6.38
(1.27)
6.43
(1.29)
Baseline: Sno (n=28,27,27,26,28)
25.00
(27.01)
32.59
(34.26)
31.85
(31.99)
23.08
(29.77)
31.43
(29.53)
Baseline: Som (n=28,27,27,26,28)
29.05
(19.13)
28.64
(17.81)
34.57
(25.22)
32.05
(22.86)
31.90
(19.49)
Week 2: SPS (n=27,27,27,25,26)
27.04
(11.52)
25.19
(12.55)
22.10
(16.28)
27.87
(19.41)
26.67
(16.49)
Week 2: OSP (n=28,27,27,26,28)
27.61
(10.05)
25.62
(12.35)
22.78
(15.29)
27.47
(18.67)
27.74
(15.79)
Week 2: Ade (n=28,27,27,26,28)
53.33
(23.86)
54.81
(22.42)
64.07
(27.49)
51.20
(29.48)
55.38
(25.33)
Week 2: ASOB (n=28,27,27,26,28)
5.93
(16.47)
4.44
(8.47)
8.15
(20.95)
7.20
(12.75)
4.62
(11.74)
Week 2: SD (n=28,27,27,26,28)
22.31
(14.11)
19.68
(19.19)
17.92
(14.88)
21.40
(21.39)
21.44
(18.22)
Week 2: Opt (n=28,27,27,26,28)
0.63
(0.49)
0.44
(0.51)
0.56
(0.51)
0.52
(0.51)
0.38
(0.50)
Week 2: Qua (n=28,27,27,26,28)
6.70
(0.82)
6.52
(1.16)
6.70
(1.14)
6.84
(1.25)
6.50
(1.24)
Week 2: Sno (n=28,27,27,26,28)
25.19
(26.94)
25.19
(22.60)
23.70
(29.89)
17.60
(24.71)
30.00
(34.06)
Week 2: Som (n=28,27,27,26,28)
30.37
(18.05)
29.14
(19.93)
27.90
(23.46)
26.13
(23.88)
35.64
(20.65)
Week 12: SPS (n=26,24,24,21,24)
24.49
(10.83)
24.17
(14.22)
23.89
(11.78)
25.56
(14.47)
28.75
(14.24)
Week 12: OSP (n=26,24,24,21,24)
25.19
(10.33)
24.19
(13.39)
23.08
(10.74)
24.52
(14.29)
29.56
(13.10)
Week 12: Ade (n=26,24,24,21,24)
60.00
(22.63)
58.75
(26.75)
51.67
(24.08)
53.33
(23.94)
54.17
(19.54)
Week 12: ASOB (n=26,24,24,21,24)
6.92
(13.79)
9.17
(14.42)
5.00
(10.63)
3.81
(8.05)
10.00
(20.43)
Week 12: SD (n=26,24,24,21,24)
20.34
(13.42)
19.22
(18.43)
14.43
(10.52)
18.99
(19.05)
21.09
(16.56)
Week 12: Opt (n=26,24,24,21,24)
0.54
(0.51)
0.38
(0.49)
0.38
(0.49)
0.48
(0.51)
0.46
(0.51)
Week 12: Qua (n=26,24,24,21,24)
6.35
(1.20)
6.54
(1.28)
6.38
(0.97)
6.71
(1.38)
6.54
(1.53)
Week 12: Sno (n=26,24,24,21,24)
24.62
(22.13)
21.67
(22.78)
29.17
(32.83)
13.33
(20.33)
33.33
(31.02)
Week 12: Som (n=26,24,24,21,24)
30.26
(18.59)
25.28
(20.99)
25.28
(16.33)
24.13
(23.24)
40.28
(19.51)
27. Secondary Outcome
Title Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale
Description FACIT-F 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-Fatigue 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/EOT

Outcome Measure Data

Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Measure Participants 28 27 27 26 28
Baseline (n=28,27,27,26,28)
34.25
(10.45)
33.37
(11.03)
34.48
(9.99)
36.85
(9.43)
37.07
(9.87)
Week 2 (n=27,27,27,25,26)
36.78
(8.64)
36.48
(9.72)
39.30
(10.56)
40.80
(6.87)
37.38
(10.31)
Week 12 (n=26,24,24,21,24)
39.35
(7.47)
37.96
(9.95)
42.79
(8.47)
40.76
(10.65)
36.46
(9.93)

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 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
All Cause Mortality
CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
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)
Serious Adverse Events
CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/28 (3.6%) 1/27 (3.7%) 1/27 (3.7%) 2/26 (7.7%) 0/28 (0%)
Cardiac disorders
Cardiac failure 0/28 (0%) 0/27 (0%) 0/27 (0%) 1/26 (3.8%) 0/28 (0%)
Injury, poisoning and procedural complications
Femur fracture 0/28 (0%) 0/27 (0%) 1/27 (3.7%) 0/26 (0%) 0/28 (0%)
Musculoskeletal and connective tissue disorders
Foot deformity 1/28 (3.6%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Osteoarthritis 0/28 (0%) 1/27 (3.7%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea 0/28 (0%) 0/27 (0%) 0/27 (0%) 1/26 (3.8%) 0/28 (0%)
Other (Not Including Serious) Adverse Events
CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 14/28 (50%) 16/27 (59.3%) 19/27 (70.4%) 19/26 (73.1%) 11/28 (39.3%)
Eye disorders
Cataract 0/28 (0%) 0/27 (0%) 0/27 (0%) 1/26 (3.8%) 0/28 (0%)
Conjunctivitis 0/28 (0%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 1/28 (3.6%)
Dry eye 0/28 (0%) 0/27 (0%) 0/27 (0%) 1/26 (3.8%) 0/28 (0%)
Eyelid pain 0/28 (0%) 0/27 (0%) 1/27 (3.7%) 0/26 (0%) 0/28 (0%)
Vision blurred 0/28 (0%) 0/27 (0%) 0/27 (0%) 1/26 (3.8%) 0/28 (0%)
Gastrointestinal disorders
Abdominal pain 1/28 (3.6%) 0/27 (0%) 1/27 (3.7%) 0/26 (0%) 0/28 (0%)
Constipation 0/28 (0%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 1/28 (3.6%)
Diarrhoea 1/28 (3.6%) 0/27 (0%) 1/27 (3.7%) 1/26 (3.8%) 0/28 (0%)
Gastric mucosal lesion 0/28 (0%) 0/27 (0%) 0/27 (0%) 1/26 (3.8%) 0/28 (0%)
Gastritis 0/28 (0%) 0/27 (0%) 1/27 (3.7%) 0/26 (0%) 0/28 (0%)
Gastrooesophageal reflux disease 0/28 (0%) 0/27 (0%) 1/27 (3.7%) 0/26 (0%) 0/28 (0%)
Haematochezia 0/28 (0%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 1/28 (3.6%)
Nausea 0/28 (0%) 0/27 (0%) 0/27 (0%) 1/26 (3.8%) 0/28 (0%)
Paraesthesia oral 1/28 (3.6%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Stomach discomfort 0/28 (0%) 0/27 (0%) 3/27 (11.1%) 0/26 (0%) 0/28 (0%)
Stomatitis 2/28 (7.1%) 0/27 (0%) 0/27 (0%) 1/26 (3.8%) 0/28 (0%)
General disorders
Chest pain 0/28 (0%) 0/27 (0%) 0/27 (0%) 1/26 (3.8%) 0/28 (0%)
Fatigue 0/28 (0%) 0/27 (0%) 0/27 (0%) 1/26 (3.8%) 0/28 (0%)
Malaise 1/28 (3.6%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 1/28 (3.6%)
Pyrexia 0/28 (0%) 1/27 (3.7%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Infections and infestations
Acute tonsillitis 0/28 (0%) 1/27 (3.7%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Bronchitis 0/28 (0%) 0/27 (0%) 1/27 (3.7%) 0/26 (0%) 0/28 (0%)
Cystitis 0/28 (0%) 0/27 (0%) 1/27 (3.7%) 1/26 (3.8%) 0/28 (0%)
Dermatitis infected 0/28 (0%) 1/27 (3.7%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Enterocolitis viral 0/28 (0%) 1/27 (3.7%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Erysipelas 0/28 (0%) 0/27 (0%) 0/27 (0%) 1/26 (3.8%) 0/28 (0%)
Gastroenteritis 0/28 (0%) 2/27 (7.4%) 0/27 (0%) 1/26 (3.8%) 1/28 (3.6%)
Gastroenteritis viral 0/28 (0%) 0/27 (0%) 0/27 (0%) 1/26 (3.8%) 0/28 (0%)
Localised infection 0/28 (0%) 0/27 (0%) 0/27 (0%) 1/26 (3.8%) 0/28 (0%)
Nasopharyngitis 3/28 (10.7%) 1/27 (3.7%) 1/27 (3.7%) 4/26 (15.4%) 4/28 (14.3%)
Paronychia 0/28 (0%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 1/28 (3.6%)
Pharyngitis 0/28 (0%) 0/27 (0%) 0/27 (0%) 2/26 (7.7%) 0/28 (0%)
Pneumonia 0/28 (0%) 0/27 (0%) 1/27 (3.7%) 1/26 (3.8%) 0/28 (0%)
Tinea pedis 0/28 (0%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 1/28 (3.6%)
Upper respiratory tract infection 0/28 (0%) 1/27 (3.7%) 0/27 (0%) 0/26 (0%) 1/28 (3.6%)
Viral upper respiratory tract infection 0/28 (0%) 0/27 (0%) 0/27 (0%) 1/26 (3.8%) 0/28 (0%)
Vulvovaginal candidiasis 0/28 (0%) 0/27 (0%) 0/27 (0%) 1/26 (3.8%) 0/28 (0%)
Vulvovaginitis trichomonal 0/28 (0%) 1/27 (3.7%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Injury, poisoning and procedural complications
Fall 0/28 (0%) 1/27 (3.7%) 1/27 (3.7%) 1/26 (3.8%) 1/28 (3.6%)
Foot fracture 0/28 (0%) 1/27 (3.7%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Joint sprain 0/28 (0%) 0/27 (0%) 0/27 (0%) 1/26 (3.8%) 0/28 (0%)
Spinal compression fracture 0/28 (0%) 1/27 (3.7%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Thermal burn 0/28 (0%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 1/28 (3.6%)
Investigations
Alanine aminotransferase increased 1/28 (3.6%) 2/27 (7.4%) 6/27 (22.2%) 2/26 (7.7%) 1/28 (3.6%)
Apolipoprotein A-I increased 0/28 (0%) 1/27 (3.7%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Aspartate aminotransferase increased 1/28 (3.6%) 2/27 (7.4%) 4/27 (14.8%) 1/26 (3.8%) 1/28 (3.6%)
Blood alkaline phosphatase increased 0/28 (0%) 1/27 (3.7%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Blood cholesterol increased 0/28 (0%) 3/27 (11.1%) 1/27 (3.7%) 1/26 (3.8%) 0/28 (0%)
Blood creatine phosphokinase MM increased 0/28 (0%) 0/27 (0%) 1/27 (3.7%) 0/26 (0%) 0/28 (0%)
Blood triglycerides increased 1/28 (3.6%) 1/27 (3.7%) 1/27 (3.7%) 2/26 (7.7%) 0/28 (0%)
Epstein-Barr virus test positive 1/28 (3.6%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Haemoglobin decreased 0/28 (0%) 0/27 (0%) 1/27 (3.7%) 0/26 (0%) 0/28 (0%)
Low density lipoprotein increased 0/28 (0%) 2/27 (7.4%) 1/27 (3.7%) 2/26 (7.7%) 0/28 (0%)
Lymphocyte count decreased 0/28 (0%) 1/27 (3.7%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Lymphocyte percentage decreased 0/28 (0%) 1/27 (3.7%) 1/27 (3.7%) 0/26 (0%) 0/28 (0%)
Viral DNA test positive 0/28 (0%) 1/27 (3.7%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
White blood cell count decreased 0/28 (0%) 0/27 (0%) 2/27 (7.4%) 1/26 (3.8%) 0/28 (0%)
Metabolism and nutrition disorders
Hypercholesterolaemia 0/28 (0%) 0/27 (0%) 1/27 (3.7%) 0/26 (0%) 0/28 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia 1/28 (3.6%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Back pain 0/28 (0%) 0/27 (0%) 0/27 (0%) 1/26 (3.8%) 0/28 (0%)
Intervertebral disc protrusion 0/28 (0%) 1/27 (3.7%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Joint swelling 1/28 (3.6%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Monarthritis 0/28 (0%) 1/27 (3.7%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Muscle fatigue 1/28 (3.6%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Muscle tightness 0/28 (0%) 0/27 (0%) 0/27 (0%) 1/26 (3.8%) 0/28 (0%)
Musculoskeletal pain 0/28 (0%) 1/27 (3.7%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Myalgia 0/28 (0%) 0/27 (0%) 0/27 (0%) 1/26 (3.8%) 0/28 (0%)
Synovial cyst 0/28 (0%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 1/28 (3.6%)
Nervous system disorders
Cervical myelopathy 0/28 (0%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 1/28 (3.6%)
Dizziness 1/28 (3.6%) 0/27 (0%) 0/27 (0%) 1/26 (3.8%) 0/28 (0%)
Headache 2/28 (7.1%) 0/27 (0%) 2/27 (7.4%) 0/26 (0%) 1/28 (3.6%)
Hypoaesthesia 1/28 (3.6%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Sciatica 0/28 (0%) 0/27 (0%) 1/27 (3.7%) 0/26 (0%) 0/28 (0%)
Psychiatric disorders
Insomnia 0/28 (0%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 1/28 (3.6%)
Renal and urinary disorders
Calculus ureteric 0/28 (0%) 0/27 (0%) 1/27 (3.7%) 0/26 (0%) 0/28 (0%)
Cystitis-like symptom 0/28 (0%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 1/28 (3.6%)
Enuresis 0/28 (0%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 1/28 (3.6%)
Urinary incontinence 0/28 (0%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 1/28 (3.6%)
Reproductive system and breast disorders
Breast pain 0/28 (0%) 0/27 (0%) 0/27 (0%) 1/26 (3.8%) 0/28 (0%)
Dysmenorrhoea 0/28 (0%) 0/27 (0%) 0/27 (0%) 1/26 (3.8%) 0/28 (0%)
Metrorrhagia 0/28 (0%) 1/27 (3.7%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Respiratory, thoracic and mediastinal disorders
Cough 0/28 (0%) 1/27 (3.7%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Pleural effusion 1/28 (3.6%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Upper respiratory tract inflammation 1/28 (3.6%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Skin and subcutaneous tissue disorders
Dermatitis contact 0/28 (0%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 1/28 (3.6%)
Erythema 1/28 (3.6%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 2/28 (7.1%)
Haemorrhage subcutaneous 0/28 (0%) 0/27 (0%) 0/27 (0%) 1/26 (3.8%) 0/28 (0%)
Hyperhidrosis 0/28 (0%) 0/27 (0%) 1/27 (3.7%) 0/26 (0%) 0/28 (0%)
Pruritus 1/28 (3.6%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 0/28 (0%)
Purpura 0/28 (0%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 1/28 (3.6%)
Rash 0/28 (0%) 0/27 (0%) 0/27 (0%) 2/26 (7.7%) 0/28 (0%)
Skin ulcer 0/28 (0%) 0/27 (0%) 0/27 (0%) 0/26 (0%) 1/28 (3.6%)
Vascular disorders
Peritonsillitis 0/28 (0%) 0/27 (0%) 0/27 (0%) 1/26 (3.8%) 0/28 (0%)
Hypertension 0/28 (0%) 0/27 (0%) 1/27 (3.7%) 0/26 (0%) 0/28 (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:
NCT00603512
Other Study ID Numbers:
  • A3921039
First Posted:
Jan 29, 2008
Last Update Posted:
Jan 25, 2013
Last Verified:
Dec 1, 2012