Three Dose Levels of CP-690,550 Monotherapy Versus Placebo, Administered Orally Twice Daily (BID) for 6 Weeks
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00147498
Collaborator
(none)
264
60
4
17
4.4
0.3
Study Details
Study Description
Brief Summary
The study's objective is to compare the efficacy of 3 dose levels of oral CP-690,550 monotherapy (5 mg, 15 mg, and 30 mg twice daily [BID]) versus placebo administered over 6 weeks for the treatment of the signs and symptoms of subjects with active rheumatoid arthritis (RA).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
264 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Compare 3 Dose Levels Of CP-690,550 Versus Placebo, Administered Orally Twice Daily (BID) For 6 Weeks, In The Treatment Of The Signs And Symptoms Of Subjects With Active Rheumatoid Arthritis
Study Start Date
:
Jan 1, 2005
Actual Primary Completion Date
:
Jun 1, 2006
Actual Study Completion Date
:
Jun 1, 2006
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 5 mg BID CP 690,550 5 mg BID |
Drug: CP-690,550
Oral tablets administered at a dose of 5 mg BID for 6 weeks
|
| Experimental: 15 mg BID CP 690,550 15 mg BID |
Drug: CP-690,550
Oral tablets administered at a dose of 15 mg BID for 6 weeks
|
| Experimental: 30 mg BID Oral tablets administered at a dose of 30 mg BID for 6 weeks |
Drug: CP-690,550
30 mg BID for 6 weeks
|
| Placebo Comparator: Placebo Placebo |
Other: Placebo
Placebo tablets
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6 [Week 6]
ACR20 response: greater than or equal to (>=) 20 percent (%) 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
- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response [Week 1, 2, 4, and 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.
- Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response [Week 1, 2, 4, 6, and 8]
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.
- Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response [Week 1, 2, 4, 6, and 8]
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.
- Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve [Baseline up to Week 6]
ACR-n: calculated 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 AUC of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.
- Tender Joints Count (TJC) [Baseline, Week 1, 2, 4, 6, and 8]
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.
- Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8 [Baseline, Week 1, 2, 4, 6, and 8]
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 indicated an improvement.
- Swollen Joints Count (SJC) [Baseline, Week 1, 2, 4, 6, and 8]
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.
- Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8 [Baseline, Week 1, 2, 4, 6, and 8]
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.
- Patient Global Assessment (PtGA) of Arthritis [Baseline, Week 1, 2, 4, 6, and 8]
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 millimeter (mm) Visual Analog Scale (VAS) where 0 mm = very well and 100 mm = very poorly.
- Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8 [Baseline, Week 1, 2, 4, 6, and 8]
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.
- Physician Global Assessment of Arthritis [Baseline, Week 1, 2, 4, 6, and 8]
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
- Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8 [Baseline, Week 1, 2, 4, 6, and 8]
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
- Patient Assessment of Arthritis Pain [Baseline, Week 1, 2, 4, 6, and 8]
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.
- Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8 [Baseline, Week 1, 2, 4, 6, and 8]
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.
- Health Assessment Questionnaire-Disability Index (HAQ-DI) [Baseline, Week 1, 2, 4, 6, and 8]
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.
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8 [Baseline, Week 1, 2, 4, 6, and 8]
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.
- C-Reactive Protein (CRP) [Baseline, Week 1, 2, 4, 6, and 8]
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 100 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
- Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8 [Baseline, Week 1, 2, 4, 6, and 8]
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 mg/L to 100 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
- Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) [Baseline, Week 1, 2, 4, 6, and 8]
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score ranging 0 to 9.4; higher scores indicated greater affectation due to disease activity. DAS 28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and less than (<) 2.6 = remission.
- Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8 [Baseline, Week 1, 2, 4, 6, and 8]
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score ranging 0 to 9.4; higher scores indicated greater affectation due to disease activity. DAS 28-3 (CRP) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and <2.6 = remission.
- Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) [Baseline, Week 1, 2, 4, 6, and 8]
Disease improvement was classified as good, moderate, and no change 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 improvement. Scores of good and moderate were considered to have therapeutic response.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- The subject has a history of inadequate response to at least 1, but no more than 4, of the following DMARDs: sulfasalazine, injectable gold, methotrexate, leflunomide, cyclosporine, or a thiopurine derivative (azathioprine or 6-mercaptopurine)
Exclusion Criteria:
- Current Therapy With Any DMARD Or Biologic
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Upland | California | United States | 91786 |
| 2 | Pfizer Investigational Site | Clearwater | Florida | United States | 33765 |
| 3 | Pfizer Investigational Site | Miami | Florida | United States | 33173 |
| 4 | Pfizer Investigational Site | New Port Richey | Florida | United States | 34652 |
| 5 | Pfizer Investigational Site | Ocala | Florida | United States | 34474-7455 |
| 6 | Pfizer Investigational Site | Orlando | Florida | United States | 32804 |
| 7 | Pfizer Investigational Site | Port Richey | Florida | United States | 34668 |
| 8 | Pfizer Investigational Site | Tampa | Florida | United States | 33614 |
| 9 | Pfizer Investigational Site | Dubuque | Iowa | United States | 52001-7313 |
| 10 | Pfizer Investigational Site | Dubuque | Iowa | United States | 52002 |
| 11 | Pfizer Investigational Site | Concord | New Hampshire | United States | 03301 |
| 12 | Pfizer Investigational Site | Plainview | New York | United States | 11803 |
| 13 | Pfizer Investigational Site | Charlotte | North Carolina | United States | 28210 |
| 14 | Pfizer Investigational Site | Hickory | North Carolina | United States | 28601 |
| 15 | Pfizer Investigational Site | Hickory | North Carolina | United States | 28602 |
| 16 | Pfizer Investigational Site | Dayton | Ohio | United States | 45402 |
| 17 | Pfizer Investigational Site | Ducansville | Pennsylvania | United States | 16635 |
| 18 | Pfizer Investigational Site | Johnstown | Pennsylvania | United States | 15904 |
| 19 | Pfizer Investigational Site | Charleston | South Carolina | United States | 29406 |
| 20 | Pfizer Investigational Site | Columbia | South Carolina | United States | 29204 |
| 21 | Pfizer Investigational Site | Nashville | Tennessee | United States | 37203 |
| 22 | Pfizer Investigational Site | Dallas | Texas | United States | 75231-4496 |
| 23 | Pfizer Investigational Site | Everett | Washington | United States | 98201 |
| 24 | Pfizer Investigational Site | Tacoma | Washington | United States | 98405 |
| 25 | Pfizer Investigational Site | Gent | Belgium | 9000 | |
| 26 | Pfizer Investigational Site | Goiânia | GO | Brazil | 74043-110 |
| 27 | Pfizer Investigational Site | Goiânia | GO | Brazil | 74110-120 |
| 28 | Pfizer Investigational Site | Curitiba | PR | Brazil | 80060-240 |
| 29 | Pfizer Investigational Site | São Paulo | SP | Brazil | 04230-000 |
| 30 | Pfizer Investigational Site | São Paulo | SP | Brazil | 05001-000 |
| 31 | Pfizer Investigational Site | Edmonton | Alberta | Canada | T5M 0H4 |
| 32 | Pfizer Investigational Site | Victoria | British Columbia | Canada | V8P 5P6 |
| 33 | Pfizer Investigational Site | Saint John's | Newfoundland and Labrador | Canada | A1C 5B8 |
| 34 | Pfizer Investigational Site | London | Ontario | Canada | N6A 4V2 |
| 35 | Pfizer Investigational Site | Toronto | Ontario | Canada | M5T 2S8 |
| 36 | Pfizer Investigational Site | Berlin | Germany | 10098 | |
| 37 | Pfizer Investigational Site | Dresden | Germany | 01067 | |
| 38 | Pfizer Investigational Site | Hamburg | Germany | 22081 | |
| 39 | Pfizer Investigational Site | Hildesheim | Germany | 31134 | |
| 40 | Pfizer Investigational Site | Leipzig | Germany | 04103 | |
| 41 | Pfizer Investigational Site | Muenchen | Germany | 80639 | |
| 42 | Pfizer Investigational Site | Neubrandenburg | Germany | 17033 | |
| 43 | Pfizer Investigational Site | Wiesbaden | Germany | 65191 | |
| 44 | Pfizer Investigational Site | Firenze | Italy | 50139 | |
| 45 | Pfizer Investigational Site | Genova | Italy | 16132 | |
| 46 | Pfizer Investigational Site | Pavia | Italy | 27100 | |
| 47 | Pfizer Investigational Site | México | D.f. | Mexico | 06726 |
| 48 | Pfizer Investigational Site | Tlalpan Seccion 16 | DF | Mexico | 14000 |
| 49 | Pfizer Investigational Site | Guadalajara | Jalisco | Mexico | 44690 |
| 50 | Pfizer Investigational Site | Aguascalientes | Mexico | 20230 | |
| 51 | Pfizer Investigational Site | San Luis Potosí | Mexico | 78240 | |
| 52 | Pfizer Investigational Site | Kosice | Slovakia | 040 11 | |
| 53 | Pfizer Investigational Site | Piestany | Slovakia | 921 01 | |
| 54 | Pfizer Investigational Site | Zilina | Slovakia | 012 07 | |
| 55 | Pfizer Investigational Site | L´hospitalet de Llobregat | Barcelona | Spain | 08907 |
| 56 | Pfizer Investigational Site | Santiago de Compostela | La Coruña | Spain | 15706 |
| 57 | Pfizer Investigational Site | Barcelona | Spain | 08003 | |
| 58 | Pfizer Investigational Site | Guadalajara | Spain | 19002 | |
| 59 | Pfizer Investigational Site | Madrid | Spain | 28046 | |
| 60 | Pfizer Investigational Site | Sevilla | Spain | 41014 |
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:
NCT00147498
Other Study ID Numbers:
- A3921019
First Posted:
Sep 7, 2005
Last Update Posted:
Jan 30, 2013
Last Verified:
Dec 1, 2012
Keywords provided by Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. |
| Period Title: Overall Study | ||||
| STARTED | 61 | 69 | 69 | 65 |
| COMPLETED | 58 | 60 | 52 | 48 |
| NOT COMPLETED | 3 | 9 | 17 | 17 |
Baseline Characteristics
| Arm/Group Title | CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo | Total |
|---|---|---|---|---|---|
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. | Total of all reporting groups |
| Overall Participants | 61 | 69 | 69 | 65 | 264 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
47.9
(10.8)
|
51.8
(13.0)
|
51.1
(10.6)
|
51.3
(12.1)
|
50.6
(11.7)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
53
86.9%
|
58
84.1%
|
60
87%
|
55
84.6%
|
226
85.6%
|
| Male |
8
13.1%
|
11
15.9%
|
9
13%
|
10
15.4%
|
38
14.4%
|
Outcome Measures
| Title | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6 |
|---|---|
| Description | ACR20 response: greater than or equal to (>=) 20 percent (%) 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 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study treatment. |
| Arm/Group Title | CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. |
| Measure Participants | 61 | 69 | 69 | 65 |
| Number [percentage of participants] |
70.49
115.6%
|
81.16
117.6%
|
76.81
111.3%
|
29.23
45%
|
| 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, and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS included all randomized participants who received at least 1 dose of study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF) at Week 1, 2, and 4. Here 'n' is number of participants evaluable at specific time points for each arm group, respectively. |
| Arm/Group Title | CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. |
| Measure Participants | 61 | 69 | 69 | 65 |
| Week 1 (n=61,69,69,65) |
27.87
45.7%
|
43.48
63%
|
56.52
81.9%
|
12.31
18.9%
|
| Week 2 (n=61,69,69,65) |
50.82
83.3%
|
71.01
102.9%
|
68.12
98.7%
|
20.00
30.8%
|
| Week 4 (n=61,69,69,65) |
63.93
104.8%
|
75.36
109.2%
|
75.36
109.2%
|
30.77
47.3%
|
| Week 8 (n=56,56,51,45) |
50.00
82%
|
66.07
95.8%
|
70.59
102.3%
|
28.89
44.4%
|
| 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 1, 2, 4, 6, and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS included all randomized participants who received at least 1 dose of study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF) at Week 1, 2, 4, and 6. Here 'n' is number of participants evaluable at specific time points for each arm group, respectively. |
| Arm/Group Title | CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. |
| Measure Participants | 61 | 69 | 69 | 65 |
| Week 1 (n= 61,69,69,65) |
6.56
10.8%
|
8.70
12.6%
|
18.84
27.3%
|
3.08
4.7%
|
| Week 2 (n= 61,69,69,65) |
9.84
16.1%
|
23.19
33.6%
|
28.99
42%
|
3.08
4.7%
|
| Week 4 (n= 61,69,69,65) |
32.79
53.8%
|
42.03
60.9%
|
42.03
60.9%
|
6.15
9.5%
|
| Week 6 (n= 61,69,69,65) |
32.79
53.8%
|
53.62
77.7%
|
50.72
73.5%
|
6.15
9.5%
|
| Week 8 (n=56,56,51,45) |
17.86
29.3%
|
30.36
44%
|
45.10
65.4%
|
13.33
20.5%
|
| 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 1, 2, 4, 6, and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS included all randomized participants who received at least 1 dose of study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF) at Week 1, 2, 4, and 6. Here 'n' is number of participants evaluable at specific time points for each arm group, respectively. |
| Arm/Group Title | CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. |
| Measure Participants | 61 | 69 | 69 | 65 |
| Week 1 (n= 61,69,69,65) |
1.64
2.7%
|
4.35
6.3%
|
4.35
6.3%
|
0.00
0%
|
| Week 2 (n= 61,69,69,65) |
4.92
8.1%
|
4.35
6.3%
|
10.14
14.7%
|
1.54
2.4%
|
| Week 4 (n= 61,69,69,65) |
9.84
16.1%
|
17.39
25.2%
|
21.74
31.5%
|
1.54
2.4%
|
| Week 6 (n= 61,69,69,65) |
13.11
21.5%
|
21.74
31.5%
|
27.54
39.9%
|
3.08
4.7%
|
| Week 8 (n=56,56,51,45) |
8.93
14.6%
|
14.29
20.7%
|
27.45
39.8%
|
8.89
13.7%
|
| Title | Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve |
|---|---|
| Description | ACR-n: calculated 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 AUC of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC. |
| Time Frame | Baseline up to Week 6 |
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 who were evaluable for this measure. |
| Arm/Group Title | CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. |
| Measure Participants | 59 | 69 | 66 | 62 |
| Mean (Standard Deviation) [units on a scale*weeks] |
857.50
(1151.36)
|
1086.90
(1664.77)
|
1211.93
(2107.65)
|
-546.41
(1721.78)
|
| 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 1, 2, 4, 6, and 8 |
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 who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively. |
| Arm/Group Title | CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. |
| Measure Participants | 61 | 69 | 68 | 65 |
| Baseline (n=61,69,68,65) |
32.37
(1.588)
|
26.98
(1.485)
|
29.52
(1.499)
|
30.61
(1.529)
|
| Week 1 (n=60,68,66,59) |
23.49
(1.597)
|
16.62
(1.492)
|
15.75
(1.511)
|
27.39
(1.576)
|
| Week 2 (n=57,66,65,60) |
18.90
(1.622)
|
12.72
(1.505)
|
13.51
(1.519)
|
24.71
(1.572)
|
| Week 4 (n=56,58,59,49) |
15.33
(1.628)
|
9.97
(1.562)
|
10.17
(1.562)
|
19.78
(1.670)
|
| Week 6 (n=56,59,53,50) |
12.21
(1.630)
|
8.58
(1.556)
|
7.41
(1.612)
|
19.81
(1.661)
|
| Week 8 (n=57,56,52,45) |
16.32
(1.62)
|
11.50
(1.58)
|
11.21
(1.62)
|
20.37
(1.71)
|
| Title | Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8 |
|---|---|
| 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 indicated an improvement. |
| Time Frame | Baseline, Week 1, 2, 4, 6, and 8 |
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 who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively. |
| Arm/Group Title | CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. |
| Measure Participants | 60 | 68 | 65 | 59 |
| Change at Week 1 (n=60,68,65,59) |
-7.06
(1.435)
|
-11.70
(1.338)
|
-14.14
(1.362)
|
-2.74
(1.417)
|
| Change at Week 2 (n=57,66,65,60) |
-11.68
(1.459)
|
-15.66
(1.350)
|
-15.78
(1.365)
|
-5.13
(1.416)
|
| Change at Week 4 (n=56,58,58,49) |
-15.23
(1.465)
|
-18.33
(1.403)
|
-18.66
(1.413)
|
-10.09
(1.508)
|
| Change at Week 6 (n=56,59,52,50) |
-18.35
(1.466)
|
-19.81
(1.398)
|
-21.37
(1.461)
|
-9.69
(1.500)
|
| Change at Week 8 (n=57,56,52,45) |
-14.26
(1.46)
|
-16.89
(1.42)
|
-17.78
(1.46)
|
-9.34
(1.55)
|
| 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 1, 2, 4, 6, and 8 |
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 who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively. |
| Arm/Group Title | CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. |
| Measure Participants | 61 | 69 | 68 | 65 |
| Baseline (n=61,69,68,65) |
21.33
(1.052)
|
16.42
(0.984)
|
19.53
(0.993)
|
19.97
(1.013)
|
| Week 1 (n=60,68,66,59) |
14.77
(1.058)
|
9.90
(0.989)
|
10.18
(1.001)
|
16.46
(1.044)
|
| Week 2 (n=57,66,65,60) |
12.04
(1.074)
|
6.84
(0.997)
|
7.99
(1.006)
|
14.30
(1.041)
|
| Week 4 (n=56,58,59,49) |
8.83
(1.079)
|
5.95
(1.035)
|
6.42
(1.035)
|
11.78
(1.107)
|
| Week 6 (n=56,59,53,50) |
7.74
(1.080)
|
4.93
(1.031)
|
4.95
(1.069)
|
11.15
(1.101)
|
| Week 8 (n=57,56,52,45) |
10.31
(1.07)
|
6.02
(1.05)
|
6.77
(1.08)
|
12.36
(1.14)
|
| Title | Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8 |
|---|---|
| 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, 6, and 8 |
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 who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively. |
| Arm/Group Title | CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. |
| Measure Participants | 60 | 68 | 65 | 60 |
| Change at Week 1 (n=60,68,65,59) |
-5.02
(0.913)
|
-8.20
(0.855)
|
-9.00
(0.866)
|
-3.19
(0.900)
|
| Change at Week 2 (n=57,66,65,60) |
-7.83
(0.927)
|
-11.33
(0.863)
|
-11.11
(0.868)
|
-5.23
(0.900)
|
| Change at Week 4 (n=56,58,58,49) |
-11.03
(0.930)
|
-12.10
(0.894)
|
-12.58
(0.897)
|
-7.73
(0.954)
|
| Change at Week 6 (n=56,59,52,50) |
-12.10
(0.931)
|
-13.13
(0.891)
|
-13.91
(0.925)
|
-8.06
(0.950)
|
| Change at Week 8 (n=57,56,52,45) |
-9.54
(0.93)
|
-12.02
(0.90)
|
-12.14
(0.93)
|
-7.00
(0.98)
|
| 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 millimeter (mm) Visual Analog Scale (VAS) where 0 mm = very well and 100 mm = very poorly. |
| Time Frame | Baseline, Week 1, 2, 4, 6, and 8 |
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 who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively. |
| Arm/Group Title | CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. |
| Measure Participants | 58 | 67 | 65 | 63 |
| Baseline (n=57,67,65,63) |
71.03
(3.126)
|
69.37
(2.887)
|
63.99
(2.941)
|
65.73
(2.985)
|
| Week 1 (n=58,67,64,58) |
49.89
(3.111)
|
45.36
(2.889)
|
39.79
(2.958)
|
61.48
(3.076)
|
| Week 2 (n=55,65,62,60) |
46.18
(3.171)
|
41.09
(2.917)
|
32.09
(2.992)
|
58.02
(3.046)
|
| Week 4 (n=56,58,58,48) |
38.67
(3.146)
|
29.53
(3.033)
|
26.16
(3.062)
|
52.55
(3.294)
|
| Week 6 (n=55,59,52,49) |
37.11
(3.165)
|
28.82
(3.018)
|
24.52
(3.180)
|
50.04
(3.273)
|
| Week 8 (n=57,57,50,45) |
40.29
(3.13)
|
37.56
(3.05)
|
30.63
(3.23)
|
50.76
(3.37)
|
| Title | Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8 |
|---|---|
| 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 1, 2, 4, 6, and 8 |
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 who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively. |
| Arm/Group Title | CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. |
| Measure Participants | 56 | 66 | 62 | 59 |
| Change at Week 1 (n=56,66,62,57) |
-17.98
(3.121)
|
-21.56
(2.859)
|
-26.16
(2.948)
|
-5.18
(3.022)
|
| Change at Week 2 (n=53,63,60,59) |
-22.06
(3.184)
|
-25.71
(2.900)
|
-33.33
(2.984)
|
-8.14
(2.998)
|
| Change at Week 4 (n=53,57,55,47) |
-30.23
(3.176)
|
-37.35
(3.001)
|
-38.71
(3.072)
|
-13.17
(3.238)
|
| Change at Week 6 (n=52,57,49,48) |
-31.64
(3.203)
|
-37.78
(3.005)
|
-40.50
(3.191)
|
-15.06
(3.219)
|
| Change at Week 8 (n=53,55,48,45) |
-27.83
(3.18)
|
-28.79
(3.04)
|
-34.30
(3.21)
|
-14.96
(3.28)
|
| 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 1, 2, 4, 6, and 8 |
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 who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively. |
| Arm/Group Title | CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. |
| Measure Participants | 60 | 69 | 66 | 64 |
| Baseline (n=60,69,66,64) |
69.39
(2.566)
|
64.11
(2.388)
|
66.65
(2.436)
|
67.75
(2.471)
|
| Week 1 (n=60,67,64,58) |
49.85
(2.568)
|
37.80
(2.417)
|
36.30
(2.464)
|
55.54
(2.575)
|
| Week 2 (n=57,66,65,60) |
41.65
(2.618)
|
29.54
(2.430)
|
32.24
(2.453)
|
52.76
(2.546)
|
| Week 4 (n=56,58,59,49) |
34.18
(2.631)
|
27.45
(2.547)
|
23.91
(2.540)
|
46.01
(2.746)
|
| Week 6 (n=55,58,53,50) |
31.42
(2.651)
|
22.22
(2.549)
|
19.26
(2.643)
|
46.52
(2.727)
|
| Week 8 (n=57,57,52,45) |
39.10
(2.62)
|
30.78
(2.57)
|
26.24
(2.66)
|
42.04
(2.84)
|
| Title | Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8 |
|---|---|
| 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 1, 2, 4, 6, and 8 |
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 who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively. |
| Arm/Group Title | CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. |
| Measure Participants | 59 | 67 | 63 | 59 |
| Change at Week 1 (n=59,67,62,57) |
-17.13
(2.626)
|
-28.25
(2.445)
|
-30.89
(2.534)
|
-12.25
(2.636)
|
| Change at Week 2 (n=56,66,63,59) |
-25.43
(2.675)
|
-36.60
(2.456)
|
-34.56
(2.525)
|
-14.29
(2.611)
|
| Change at Week 4 (n=55,58,56,48) |
-33.29
(2.686)
|
-38.44
(2.563)
|
-42.65
(2.627)
|
-20.91
(2.803)
|
| Change at Week 6 (n=55,58,50,49) |
-35.97
(2.690)
|
-43.69
(2.566)
|
-46.70
(2.730)
|
-19.87
(2.786)
|
| Change at Week 8 (n=56,57,50,45) |
-29.19
(2.67)
|
-35.11
(2.58)
|
-39.81
(2.73)
|
-24.78
(2.87)
|
| Title | Patient Assessment of Arthritis Pain |
|---|---|
| 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 1, 2, 4, 6, and 8 |
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 who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively. |
| Arm/Group Title | CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. |
| Measure Participants | 59 | 68 | 66 | 64 |
| Baseline (n=59,68,66,64) |
69.46
(3.112)
|
67.47
(2.894)
|
68.13
(2.936)
|
64.17
(2.980)
|
| Week 1 (n=59,68,65,59) |
51.76
(3.114)
|
46.11
(2.897)
|
37.71
(2.953)
|
62.51
(3.072)
|
| Week 2 (n=57,65,65,60) |
45.59
(3.154)
|
40.14
(2.940)
|
30.83
(2.956)
|
60.65
(3.062)
|
| Week 4 (n=57,58,59,49) |
37.77
(3.150)
|
30.42
(3.057)
|
26.76
(3.053)
|
56.96
(3.287)
|
| Week 6 (n=55,59,53,50) |
35.57
(3.191)
|
28.35
(3.043)
|
23.39
(3.169)
|
52.75
(3.266)
|
| Week 8 (n=57,57,52,45) |
42.44
(3.15)
|
37.62
(3.08)
|
31.12
(3.19)
|
49.06
(3.39)
|
| Title | Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8 |
|---|---|
| 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 1, 2, 4, 6, and 8 |
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 who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively. |
| Arm/Group Title | CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. |
| Measure Participants | 57 | 67 | 63 | 59 |
| Change at Week 1 (n=57,67,63,58) |
-15.01
(3.102)
|
-19.74
(2.843)
|
-29.66
(2.932)
|
-3.30
(3.027)
|
| Change at Week 2 (n=55,65,63,59) |
-21.44
(3.142)
|
-26.10
(2.870)
|
-35.85
(2.936)
|
-4.79
(3.027)
|
| Change at Week 4 (n=55,57,56,48) |
-29.27
(3.137)
|
-35.47
(2.996)
|
-40.10
(3.050)
|
-8.40
(3.242)
|
| Change at Week 6 (n=54,58,51,49) |
-31.42
(3.159)
|
-37.67
(2.983)
|
-42.89
(3.144)
|
-12.26
(3.223)
|
| Change at Week 8 (n=55,56,51,45) |
-24.90
(3.14)
|
-28.70
(3.02)
|
-35.35
(3.15)
|
-16.28
(3.31)
|
| 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, 6, and 8 |
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 who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively. |
| Arm/Group Title | CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. |
| Measure Participants | 60 | 69 | 67 | 62 |
| Baseline (n=60,69,67,62) |
1.75
(0.086)
|
1.66
(0.080)
|
1.61
(0.081)
|
1.71
(0.083)
|
| Week 1 (n=60,68,65,58) |
1.46
(0.086)
|
1.37
(0.080)
|
1.19
(0.082)
|
1.63
(0.084)
|
| Week 2 (n=57,66,64,60) |
1.32
(0.087)
|
1.17
(0.081)
|
1.06
(0.082)
|
1.53
(0.084)
|
| Week 4 (n=57,57,59,47) |
1.17
(0.087)
|
1.07
(0.083)
|
0.92
(0.083)
|
1.54
(0.088)
|
| Week 6 (n=54,59,53,50) |
1.12
(0.088)
|
0.95
(0.082)
|
0.86
(0.084)
|
1.47
(0.087)
|
| Week 8 (n=57,56,52,45) |
1.30
(0.09)
|
1.06
(0.08)
|
0.92
(0.08)
|
1.52
(0.09)
|
| Title | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8 |
|---|---|
| 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, 6, and 8 |
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 who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively. |
| Arm/Group Title | CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. |
| Measure Participants | 59 | 68 | 64 | 57 |
| Change at Week 1 (n=59,68,64,55) |
-0.25
(0.066)
|
-0.30
(0.061)
|
-0.44
(0.063)
|
-0.05
(0.067)
|
| Change at Week 2 (n=56,66,63,57) |
-0.39
(0.067)
|
-0.50
(0.062)
|
-0.56
(0.063)
|
-0.15
(0.067)
|
| Change at Week 4 (n=56,57,57,44) |
-0.55
(0.067)
|
-0.60
(0.064)
|
-0.69
(0.065)
|
-0.13
(0.071)
|
| Change at Week 6 (n=55,59,51,47) |
-0.60
(0.068)
|
-0.72
(0.063)
|
-0.74
(0.067)
|
-0.20
(0.070)
|
| Change at Week 8 (n=56,56,51,43) |
-0.43
(0.07)
|
-0.60
(0.06)
|
-0.70
(0.07)
|
-0.17
(0.07)
|
| 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 100 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. |
| Time Frame | Baseline, Week 1, 2, 4, 6, and 8 |
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 who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively. |
| Arm/Group Title | CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. |
| Measure Participants | 50 | 57 | 58 | 53 |
| Baseline (n=50,57,58,53) |
31.25
(35.00)
|
25.47
(31.06)
|
28.10
(28.43)
|
22.28
(18.52)
|
| Week 1 (n=50,55,55,49) |
15.98
(16.72)
|
7.57
(9.79)
|
7.57
(11.32)
|
25.40
(30.04)
|
| Week 2 (n=46,53,53,48) |
13.18
(12.97)
|
7.25
(11.83)
|
6.50
(14.81)
|
24.41
(21.38)
|
| Week 4 (n=46,49,47,39) |
11.83
(11.10)
|
5.17
(6.72)
|
5.88
(10.98)
|
22.26
(21.07)
|
| Week 6 (n=45,49,41,41) |
12.57
(21.01)
|
6.59
(16.37)
|
6.08
(11.80)
|
22.94
(20.79)
|
| Week 8 (n=45,45,41,37) |
23.37
(22.72)
|
12.06
(12.20)
|
13.95
(14.68)
|
23.64
(29.47)
|
| Title | Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8 |
|---|---|
| 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 mg/L to 100 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. |
| Time Frame | Baseline, Week 1, 2, 4, 6, and 8 |
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 who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively. |
| Arm/Group Title | CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. |
| Measure Participants | 50 | 54 | 55 | 48 |
| Change at Week 1 (n=50,54,55,48) |
-15.28
(26.65)
|
-18.29
(28.98)
|
-21.38
(25.56)
|
-0.24
(15.40)
|
| Change at Week 2 (n=46,52,53,48) |
-16.74
(32.94)
|
-18.89
(31.87)
|
-23.06
(31.49)
|
1.79
(15.56)
|
| Change at Week 4 (n=46,49,47,39) |
-17.76
(33.31)
|
-22.02
(31.29)
|
-20.70
(25.69)
|
-0.67
(19.17)
|
| Change at Week 6 (n=45,49,41,41) |
-17.83
(35.92)
|
-18.08
(25.99)
|
-17.58
(24.76)
|
0.67
(16.81)
|
| Change at Week 8 (n=45,45,41,37) |
-7.06
(35.75)
|
-13.24
(27.69)
|
-11.81
(29.46)
|
1.32
(27.26)
|
| Title | Disease Activity Score Using 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 ranging 0 to 9.4; higher scores indicated greater affectation due to disease activity. DAS 28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and 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, 6, and 8 |
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 who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively. |
| Arm/Group Title | CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. |
| Measure Participants | 50 | 57 | 56 | 51 |
| Baseline (n=50,57,56,51) |
6.17
(0.89)
|
5.69
(0.92)
|
5.91
(0.91)
|
6.00
(0.90)
|
| Week 1 (n=49,54,54,47) |
5.29
(1.08)
|
4.42
(1.12)
|
4.28
(1.21)
|
5.66
(1.10)
|
| Week 2 (n=46,53,51,48) |
4.93
(1.08)
|
3.80
(1.17)
|
3.90
(1.17)
|
5.37
(1.15)
|
| Week 4 (n=46,49,47,39) |
4.44
(1.20)
|
3.56
(1.12)
|
3.46
(1.33)
|
4.91
(1.22)
|
| Week 6 (n=45,49,40,41) |
4.18
(1.29)
|
3.42
(1.16)
|
3.10
(1.17)
|
4.78
(1.05)
|
| Week 8 (n=45,44,41,36) |
4.75
(1.37)
|
4.08
(1.32)
|
3.93
(1.38)
|
5.02
(1.10)
|
| Title | Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8 |
|---|---|
| Description | DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score ranging 0 to 9.4; higher scores indicated greater affectation due to disease activity. DAS 28-3 (CRP) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and <2.6 = remission. |
| Time Frame | Baseline, Week 1, 2, 4, 6, and 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS included all participants who were randomized to study treatment. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable for a particular time-point for each treatment arm, respectively. |
| Arm/Group Title | CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. |
| Measure Participants | 49 | 53 | 52 | 46 |
| Change at Week 1 (n=49,53,52,45) |
-0.84
(0.74)
|
-1.28
(0.99)
|
-1.65
(0.99)
|
-0.39
(0.86)
|
| Change at Week 2 (n=46,52,50,46) |
-1.19
(0.89)
|
-1.91
(1.23)
|
-2.05
(1.25)
|
-0.59
(0.98)
|
| Change at Week 4 (n=46,49,46,37) |
-1.64
(1.16)
|
-2.18
(1.25)
|
-2.47
(1.39)
|
-1.04
(1.04)
|
| Change at Week 6 (n=45,49,39,39) |
-1.99
(1.28)
|
-2.28
(1.33)
|
-2.73
(1.32)
|
-1.20
(1.17)
|
| Change at Week 8 (n=45,44,41,35) |
-1.36
(1.32)
|
-1.60
(1.32)
|
-1.99
(1.38)
|
-0.89
(1.07)
|
| Title | Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) |
|---|---|
| Description | Disease improvement was classified as good, moderate, and no change 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 improvement. Scores of good and moderate were considered to have therapeutic response. |
| Time Frame | Baseline, Week 1, 2, 4, 6, and 8 |
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 who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively. |
| Arm/Group Title | CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo |
|---|---|---|---|---|
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. |
| Measure Participants | 49 | 53 | 52 | 46 |
| Week 1, No Change (n=49,53,52,45) |
31
50.8%
|
25
36.2%
|
17
24.6%
|
35
53.8%
|
| Week 1, Good (n=49,53,52,45) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 1, Moderate (n=49,53,52,45) |
18
29.5%
|
28
40.6%
|
35
50.7%
|
10
15.4%
|
| Week 2, No Change (n=46,52,50,46) |
20
32.8%
|
13
18.8%
|
12
17.4%
|
33
50.8%
|
| Week 2, Good (n=46,52,50,46) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 2, Moderate (n=46,52,50,46) |
26
42.6%
|
39
56.5%
|
38
55.1%
|
13
20%
|
| Week 4, No Change (n=46,49,46,37) |
14
23%
|
7
10.1%
|
8
11.6%
|
22
33.8%
|
| Week 4, Good (n=46,49,46,37) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 4, Moderate (n=46,49,46,37) |
32
52.5%
|
42
60.9%
|
38
55.1%
|
15
23.1%
|
| Week 6, No Change (n=45,49,39,39) |
11
18%
|
8
11.6%
|
3
4.3%
|
20
30.8%
|
| Week 6, Good (n=45,49,39,39) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 6, Moderate (n=45,49,39,39) |
34
55.7%
|
41
59.4%
|
36
52.2%
|
19
29.2%
|
| Week 8, No Change (n=45,44,41,35) |
21
34.4%
|
16
23.2%
|
11
15.9%
|
24
36.9%
|
| Week 8, Good (n=45,44,41,35) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 8, Moderate (n=45,44,41,35) |
24
39.3%
|
28
40.6%
|
30
43.5%
|
11
16.9%
|
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 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo | ||||
| Arm/Group Description | CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. | CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. | Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. | ||||
All Cause Mortality |
||||||||
| CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/61 (1.6%) | 5/69 (7.2%) | 3/69 (4.3%) | 1/65 (1.5%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Leukopenia | 0/61 (0%) | 1/69 (1.4%) | 0/69 (0%) | 0/65 (0%) | ||||
| Cardiac disorders | ||||||||
| Myocardial ischaemia | 0/61 (0%) | 0/69 (0%) | 1/69 (1.4%) | 0/65 (0%) | ||||
| Infections and infestations | ||||||||
| Gastroenteritis | 0/61 (0%) | 1/69 (1.4%) | 0/69 (0%) | 0/65 (0%) | ||||
| Pneumonia staphylococcal | 0/61 (0%) | 0/69 (0%) | 0/69 (0%) | 1/65 (1.5%) | ||||
| Pyelonephritis acute | 0/61 (0%) | 0/69 (0%) | 1/69 (1.4%) | 0/65 (0%) | ||||
| Whipple's disease | 0/61 (0%) | 0/69 (0%) | 1/69 (1.4%) | 0/65 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Rheumatoid arthritis | 0/61 (0%) | 1/69 (1.4%) | 0/69 (0%) | 0/65 (0%) | ||||
| Nervous system disorders | ||||||||
| Subarachnoid haemorrhage | 1/61 (1.6%) | 0/69 (0%) | 0/69 (0%) | 0/65 (0%) | ||||
| Syncope vasovagal | 0/61 (0%) | 1/69 (1.4%) | 0/69 (0%) | 0/65 (0%) | ||||
| Pregnancy, puerperium and perinatal conditions | ||||||||
| Abortion spontaneous | 0/61 (0%) | 1/69 (1.4%) | 0/69 (0%) | 0/65 (0%) | ||||
| Pregnancy | 0/61 (0%) | 1/69 (1.4%) | 0/69 (0%) | 0/65 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| CP 690,550 5 mg | CP-690,550 15 mg | CP-690,550 30 mg | Placebo | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 34/61 (55.7%) | 38/69 (55.1%) | 46/69 (66.7%) | 37/65 (56.9%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 1/61 (1.6%) | 2/69 (2.9%) | 4/69 (5.8%) | 3/65 (4.6%) | ||||
| Leukopenia | 2/61 (3.3%) | 1/69 (1.4%) | 7/69 (10.1%) | 1/65 (1.5%) | ||||
| Lymphopenia | 0/61 (0%) | 0/69 (0%) | 2/69 (2.9%) | 0/65 (0%) | ||||
| Neutropenia | 1/61 (1.6%) | 1/69 (1.4%) | 3/69 (4.3%) | 0/65 (0%) | ||||
| Thrombocytopenia | 0/61 (0%) | 1/69 (1.4%) | 2/69 (2.9%) | 0/65 (0%) | ||||
| Cardiac disorders | ||||||||
| Atrioventricular block first degree | 0/61 (0%) | 2/69 (2.9%) | 0/69 (0%) | 0/65 (0%) | ||||
| Cardiac disorder | 0/61 (0%) | 2/69 (2.9%) | 0/69 (0%) | 0/65 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 0/61 (0%) | 2/69 (2.9%) | 1/69 (1.4%) | 0/65 (0%) | ||||
| Abdominal pain upper | 4/61 (6.6%) | 2/69 (2.9%) | 2/69 (2.9%) | 0/65 (0%) | ||||
| Constipation | 3/61 (4.9%) | 0/69 (0%) | 0/69 (0%) | 2/65 (3.1%) | ||||
| Diarrhoea | 3/61 (4.9%) | 2/69 (2.9%) | 3/69 (4.3%) | 3/65 (4.6%) | ||||
| Dry mouth | 2/61 (3.3%) | 0/69 (0%) | 0/69 (0%) | 0/65 (0%) | ||||
| Dyspepsia | 0/61 (0%) | 2/69 (2.9%) | 2/69 (2.9%) | 1/65 (1.5%) | ||||
| Gastritis | 0/61 (0%) | 0/69 (0%) | 1/69 (1.4%) | 2/65 (3.1%) | ||||
| Nausea | 4/61 (6.6%) | 3/69 (4.3%) | 6/69 (8.7%) | 3/65 (4.6%) | ||||
| Toothache | 0/61 (0%) | 0/69 (0%) | 2/69 (2.9%) | 1/65 (1.5%) | ||||
| Vomiting | 3/61 (4.9%) | 1/69 (1.4%) | 3/69 (4.3%) | 2/65 (3.1%) | ||||
| General disorders | ||||||||
| Asthenia | 0/61 (0%) | 0/69 (0%) | 1/69 (1.4%) | 2/65 (3.1%) | ||||
| Fatigue | 1/61 (1.6%) | 2/69 (2.9%) | 1/69 (1.4%) | 0/65 (0%) | ||||
| Malaise | 0/61 (0%) | 1/69 (1.4%) | 3/69 (4.3%) | 0/65 (0%) | ||||
| Oedema peripheral | 3/61 (4.9%) | 1/69 (1.4%) | 3/69 (4.3%) | 2/65 (3.1%) | ||||
| Infections and infestations | ||||||||
| Gastroenteritis | 2/61 (3.3%) | 2/69 (2.9%) | 1/69 (1.4%) | 1/65 (1.5%) | ||||
| Herpes simplex | 0/61 (0%) | 2/69 (2.9%) | 2/69 (2.9%) | 0/65 (0%) | ||||
| Influenza | 3/61 (4.9%) | 2/69 (2.9%) | 4/69 (5.8%) | 2/65 (3.1%) | ||||
| Nasopharyngitis | 3/61 (4.9%) | 1/69 (1.4%) | 1/69 (1.4%) | 1/65 (1.5%) | ||||
| Sinusitis | 0/61 (0%) | 0/69 (0%) | 0/69 (0%) | 3/65 (4.6%) | ||||
| Tinea pedis | 0/61 (0%) | 3/69 (4.3%) | 1/69 (1.4%) | 0/65 (0%) | ||||
| Tinea versicolour | 2/61 (3.3%) | 0/69 (0%) | 0/69 (0%) | 0/65 (0%) | ||||
| Upper respiratory tract infection | 0/61 (0%) | 3/69 (4.3%) | 1/69 (1.4%) | 4/65 (6.2%) | ||||
| Urinary tract infection | 1/61 (1.6%) | 0/69 (0%) | 5/69 (7.2%) | 2/65 (3.1%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Contusion | 0/61 (0%) | 2/69 (2.9%) | 1/69 (1.4%) | 1/65 (1.5%) | ||||
| Investigations | ||||||||
| Alanine aminotransferase increased | 1/61 (1.6%) | 0/69 (0%) | 0/69 (0%) | 3/65 (4.6%) | ||||
| Blood lactate dehydrogenase increased | 0/61 (0%) | 0/69 (0%) | 0/69 (0%) | 2/65 (3.1%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Hypercholesterolaemia | 2/61 (3.3%) | 4/69 (5.8%) | 0/69 (0%) | 0/65 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 3/61 (4.9%) | 0/69 (0%) | 3/69 (4.3%) | 6/65 (9.2%) | ||||
| Back pain | 1/61 (1.6%) | 3/69 (4.3%) | 1/69 (1.4%) | 3/65 (4.6%) | ||||
| Muscle spasms | 0/61 (0%) | 0/69 (0%) | 0/69 (0%) | 2/65 (3.1%) | ||||
| Pain in extremity | 0/61 (0%) | 3/69 (4.3%) | 1/69 (1.4%) | 0/65 (0%) | ||||
| Rheumatoid arthritis | 1/61 (1.6%) | 3/69 (4.3%) | 2/69 (2.9%) | 4/65 (6.2%) | ||||
| Shoulder pain | 0/61 (0%) | 0/69 (0%) | 2/69 (2.9%) | 1/65 (1.5%) | ||||
| Nervous system disorders | ||||||||
| Dizziness | 0/61 (0%) | 4/69 (5.8%) | 3/69 (4.3%) | 1/65 (1.5%) | ||||
| Headache | 10/61 (16.4%) | 8/69 (11.6%) | 17/69 (24.6%) | 6/65 (9.2%) | ||||
| Somnolence | 0/61 (0%) | 2/69 (2.9%) | 2/69 (2.9%) | 1/65 (1.5%) | ||||
| Renal and urinary disorders | ||||||||
| Leukocyturia | 2/61 (3.3%) | 1/69 (1.4%) | 1/69 (1.4%) | 0/65 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Dyspnoea | 2/61 (3.3%) | 0/69 (0%) | 0/69 (0%) | 0/65 (0%) | ||||
| Pharyngolaryngeal pain | 0/61 (0%) | 3/69 (4.3%) | 3/69 (4.3%) | 1/65 (1.5%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Acne | 0/61 (0%) | 1/69 (1.4%) | 3/69 (4.3%) | 0/65 (0%) | ||||
| Ecchymosis | 0/61 (0%) | 0/69 (0%) | 2/69 (2.9%) | 0/65 (0%) | ||||
| Pruritus | 0/61 (0%) | 1/69 (1.4%) | 0/69 (0%) | 2/65 (3.1%) | ||||
| Rash | 0/61 (0%) | 3/69 (4.3%) | 3/69 (4.3%) | 1/65 (1.5%) | ||||
| Vascular disorders | ||||||||
| Hypertension | 1/61 (1.6%) | 2/69 (2.9%) | 3/69 (4.3%) | 0/65 (0%) | ||||
| Hypotension | 1/61 (1.6%) | 0/69 (0%) | 0/69 (0%) | 2/65 (3.1%) | ||||
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 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00147498
Other Study ID Numbers:
- A3921019
First Posted:
Sep 7, 2005
Last Update Posted:
Jan 30, 2013
Last Verified:
Dec 1, 2012