Trial Outcomes & Findings for Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors (NCT NCT00960440)
NCT ID: NCT00960440
Last Updated: 2018-12-19
Results Overview
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). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
399 participants
Primary outcome timeframe
Month 3
Results posted on
2018-12-19
Participant Flow
Participant milestones
| Measure |
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 5 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
133
|
134
|
66
|
66
|
|
Overall Study
COMPLETED
|
107
|
103
|
53
|
48
|
|
Overall Study
NOT COMPLETED
|
26
|
31
|
13
|
18
|
Reasons for withdrawal
| Measure |
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 5 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
12
|
12
|
4
|
4
|
|
Overall Study
Lack of Efficacy
|
2
|
5
|
3
|
8
|
|
Overall Study
Protocol Violation
|
2
|
8
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
9
|
5
|
2
|
1
|
|
Overall Study
Other
|
1
|
1
|
1
|
0
|
Baseline Characteristics
Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors
Baseline characteristics by cohort
| Measure |
CP-690,550 5 mg
n=133 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=134 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 5 mg
n=66 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
n=66 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
Total
n=399 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.4 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
55.1 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
54.3 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
54.5 years
STANDARD_DEVIATION 11.0 • n=4 Participants
|
55.0 years
STANDARD_DEVIATION 11.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
335 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: Full Analysis Set(FAS):all randomized participants who received at least 1 dose of study treatment, had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using Non-Responder Imputation(NRI). 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
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). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
Outcome measures
| Measure |
CP-690,550 5 mg
n=132 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=133 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=131 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3
|
41.67 percentage of participants
|
48.12 percentage of participants
|
24.43 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Baseline, Month 3Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
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;common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
Outcome measures
| Measure |
CP-690,550 5 mg
n=132 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=134 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=132 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3
Change at Month 3 (n=117,125,118)
|
-0.41 Units on a scale
Standard Deviation 0.52
|
-0.41 Units on a scale
Standard Deviation 0.52
|
-0.17 Units on a scale
Standard Deviation 0.41
|
—
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3
Baseline (n=132,134,132)
|
1.60 Units on a scale
Standard Deviation 0.66
|
1.50 Units on a scale
Standard Deviation 0.61
|
1.63 Units on a scale
Standard Deviation 0.66
|
—
|
PRIMARY outcome
Timeframe: Month 3Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR)(millimeter/hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment). Total score range:0-9.4, higher score=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, less than (\<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
Outcome measures
| Measure |
CP-690,550 5 mg
n=119 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=125 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=120 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3
|
6.72 percentage of participants
|
11.20 percentage of participants
|
1.67 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 2, Month 1Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
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.
Outcome measures
| Measure |
CP-690,550 5 mg
n=132 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=133 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=131 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1
Month 1
|
42.42 percentage of participants
|
44.36 percentage of participants
|
27.48 percentage of participants
|
—
|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1
Week 2
|
27.69 percentage of participants
|
32.81 percentage of participants
|
16.67 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Month 4.5, 6Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
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.
Outcome measures
| Measure |
CP-690,550 5 mg
n=132 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=133 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=66 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
n=65 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4.5 and 6
Month 4.5
|
54.55 percentage of participants
|
47.37 percentage of participants
|
50.00 percentage of participants
|
46.15 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4.5 and 6
Month 6
|
51.52 percentage of participants
|
54.89 percentage of participants
|
45.45 percentage of participants
|
40.00 percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, Month 1, 3Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
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.
Outcome measures
| Measure |
CP-690,550 5 mg
n=132 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=133 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=131 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3
Week 2
|
7.69 percentage of participants
|
5.47 percentage of participants
|
1.59 percentage of participants
|
—
|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3
Month 1
|
12.88 percentage of participants
|
17.29 percentage of participants
|
6.11 percentage of participants
|
—
|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3
Month 3
|
26.52 percentage of participants
|
27.82 percentage of participants
|
8.40 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Month 4.5 and 6Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
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.
Outcome measures
| Measure |
CP-690,550 5 mg
n=132 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=133 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=66 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
n=65 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4.5 and 6
Month 4.5
|
28.79 percentage of participants
|
28.57 percentage of participants
|
30.30 percentage of participants
|
20.00 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4.5 and 6
Month 6
|
37.12 percentage of participants
|
30.08 percentage of participants
|
28.79 percentage of participants
|
20.00 percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, Month 1, 3Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
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.
Outcome measures
| Measure |
CP-690,550 5 mg
n=132 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=133 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=131 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3
Week 2
|
2.31 percentage of participants
|
2.34 percentage of participants
|
0.00 percentage of participants
|
—
|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3
Month 1
|
7.58 percentage of participants
|
6.77 percentage of participants
|
0.00 percentage of participants
|
—
|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3
Month 3
|
13.64 percentage of participants
|
10.53 percentage of participants
|
1.53 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Month 4.5, 6Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
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.
Outcome measures
| Measure |
CP-690,550 5 mg
n=132 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=133 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=66 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
n=65 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4.5 and 6
Month 4.5
|
10.61 percentage of participants
|
12.78 percentage of participants
|
12.12 percentage of participants
|
7.69 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4.5 and 6
Month 6
|
15.91 percentage of participants
|
15.79 percentage of participants
|
10.61 percentage of participants
|
9.23 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Month 1, 3Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \<=3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.
Outcome measures
| Measure |
CP-690,550 5 mg
n=133 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=134 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=132 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3
Baseline (n=133,134,132)
|
5.38 units on a scale
Standard Deviation 1.00
|
5.31 units on a scale
Standard Deviation 0.90
|
5.39 units on a scale
Standard Deviation 0.95
|
—
|
|
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3
Week 2 (n=127,125,124)
|
4.46 units on a scale
Standard Deviation 1.23
|
4.13 units on a scale
Standard Deviation 1.04
|
5.10 units on a scale
Standard Deviation 1.13
|
—
|
|
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3
Month 1 (n=123,123,123)
|
4.14 units on a scale
Standard Deviation 1.27
|
3.92 units on a scale
Standard Deviation 1.19
|
4.92 units on a scale
Standard Deviation 1.20
|
—
|
|
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3
Month 3 (n=118,124,118)
|
3.74 units on a scale
Standard Deviation 1.31
|
3.45 units on a scale
Standard Deviation 1.32
|
4.78 units on a scale
Standard Deviation 1.34
|
—
|
SECONDARY outcome
Timeframe: Month 4.5, 6Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.
Outcome measures
| Measure |
CP-690,550 5 mg
n=112 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=113 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=56 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
n=51 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6
Month 4.5 (n=112,113,56,51)
|
3.43 units on a scale
Standard Deviation 1.25
|
3.30 units on a scale
Standard Deviation 1.37
|
3.57 units on a scale
Standard Deviation 1.15
|
3.69 units on a scale
Standard Deviation 1.15
|
|
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6
Month 6 (n=100,102,51,48)
|
3.36 units on a scale
Standard Deviation 1.24
|
3.07 units on a scale
Standard Deviation 1.18
|
3.46 units on a scale
Standard Deviation 1.13
|
3.68 units on a scale
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission.
Outcome measures
| Measure |
CP-690,550 5 mg
n=126 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=128 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=130 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3
Baseline (n=126,128,130)
|
6.48 units on a scale
Standard Deviation 1.03
|
6.40 units on a scale
Standard Deviation 0.89
|
6.47 units on a scale
Standard Deviation 0.98
|
—
|
|
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3
Month 3 (n=112,121,110)
|
4.58 units on a scale
Standard Deviation 1.39
|
4.26 units on a scale
Standard Deviation 1.48
|
5.56 units on a scale
Standard Deviation 1.45
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission.
Outcome measures
| Measure |
CP-690,550 5 mg
n=100 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=100 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=49 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
n=47 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6
|
3.99 units on a scale
Standard Deviation 1.41
|
3.70 units on a scale
Standard Deviation 1.25
|
4.07 units on a scale
Standard Deviation 1.26
|
4.39 units on a scale
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: Week 2, Month 1, 3Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
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; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty.
Outcome measures
| Measure |
CP-690,550 5 mg
n=130 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=128 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=125 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3
Week 2 (n=130,128,125)
|
1.38 units on a scale
Standard Deviation 0.71
|
1.28 units on a scale
Standard Deviation 0.58
|
1.49 units on a scale
Standard Deviation 0.63
|
—
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3
Month 1 (n=123,123,123)
|
1.37 units on a scale
Standard Deviation 0.68
|
1.19 units on a scale
Standard Deviation 0.65
|
1.38 units on a scale
Standard Deviation 0.72
|
—
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3
Month 3 (n=118,125,118)
|
1.20 units on a scale
Standard Deviation 0.72
|
1.10 units on a scale
Standard Deviation 0.66
|
1.44 units on a scale
Standard Deviation 0.72
|
—
|
SECONDARY outcome
Timeframe: Month 4.5, 6Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
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; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty.
Outcome measures
| Measure |
CP-690,550 5 mg
n=112 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=114 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=57 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
n=53 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6
Month 4.5 (n=112,114,57,53)
|
1.19 units on a scale
Standard Deviation 0.69
|
1.10 units on a scale
Standard Deviation 0.70
|
1.08 units on a scale
Standard Deviation 0.60
|
1.26 units on a scale
Standard Deviation 0.75
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6
Month 6 (n=104,103,51,49)
|
1.10 units on a scale
Standard Deviation 0.70
|
1.02 units on a scale
Standard Deviation 0.65
|
1.00 units on a scale
Standard Deviation 0.59
|
1.29 units on a scale
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Month 1, 3Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Outcome measures
| Measure |
CP-690,550 5 mg
n=130 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=128 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=131 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3
Baseline (n=127,128,131)
|
65.73 units on a scale
Standard Deviation 22.79
|
60.10 units on a scale
Standard Deviation 23.16
|
60.74 units on a scale
Standard Deviation 23.50
|
—
|
|
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3
Week 2 (n=130,128,125)
|
49.79 units on a scale
Standard Deviation 26.60
|
42.35 units on a scale
Standard Deviation 22.11
|
55.88 units on a scale
Standard Deviation 23.85
|
—
|
|
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3
Month 1 (n=124,122,123)
|
45.59 units on a scale
Standard Deviation 26.02
|
39.09 units on a scale
Standard Deviation 24.05
|
52.29 units on a scale
Standard Deviation 25.65
|
—
|
|
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3
Month 3 (n=119,124,116)
|
38.91 units on a scale
Standard Deviation 27.11
|
37.72 units on a scale
Standard Deviation 26.99
|
53.40 units on a scale
Standard Deviation 26.52
|
—
|
SECONDARY outcome
Timeframe: Month 4.5, 6Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
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.
Outcome measures
| Measure |
CP-690,550 5 mg
n=112 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=115 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=56 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
n=53 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Patient Assessment of Arthritis Pain at Month 4.5 and 6
Month 4.5 (n=112,115,56,53)
|
38.93 units on a scale
Standard Deviation 26.40
|
35.01 units on a scale
Standard Deviation 24.60
|
33.11 units on a scale
Standard Deviation 23.44
|
40.62 units on a scale
Standard Deviation 26.67
|
|
Patient Assessment of Arthritis Pain at Month 4.5 and 6
Month 6 (n=104,103,51,49)
|
34.38 units on a scale
Standard Deviation 25.33
|
29.56 units on a scale
Standard Deviation 22.77
|
31.37 units on a scale
Standard Deviation 24.76
|
40.71 units on a scale
Standard Deviation 25.88
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Month 1, 3Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
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.
Outcome measures
| Measure |
CP-690,550 5 mg
n=130 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=128 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=131 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3
Baseline (n=127,128,131)
|
64.69 units on a scale
Standard Deviation 23.22
|
58.79 units on a scale
Standard Deviation 23.59
|
61.87 units on a scale
Standard Deviation 22.92
|
—
|
|
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3
Week 2 (n=130,128,124)
|
48.24 units on a scale
Standard Deviation 25.54
|
41.75 units on a scale
Standard Deviation 21.79
|
57.70 units on a scale
Standard Deviation 23.77
|
—
|
|
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3
Month 1 (n=124,123,123)
|
44.86 units on a scale
Standard Deviation 25.62
|
38.35 units on a scale
Standard Deviation 23.38
|
51.39 units on a scale
Standard Deviation 26.01
|
—
|
|
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3
Month 3 (n=119,125,118)
|
41.23 units on a scale
Standard Deviation 27.06
|
37.23 units on a scale
Standard Deviation 25.65
|
52.85 units on a scale
Standard Deviation 25.64
|
—
|
SECONDARY outcome
Timeframe: Month 4.5, 6Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
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.
Outcome measures
| Measure |
CP-690,550 5 mg
n=112 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=115 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=56 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
n=53 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6
Month 6 (n=104,103,51,49)
|
34.59 units on a scale
Standard Deviation 24.82
|
31.25 units on a scale
Standard Deviation 23.25
|
34.88 units on a scale
Standard Deviation 23.84
|
38.61 units on a scale
Standard Deviation 22.27
|
|
Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6
Month 4.5 (n=112,115,56,53)
|
37.40 units on a scale
Standard Deviation 24.65
|
36.01 units on a scale
Standard Deviation 25.46
|
34.38 units on a scale
Standard Deviation 23.47
|
38.79 units on a scale
Standard Deviation 26.17
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Month 1, 3Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Outcome measures
| Measure |
CP-690,550 5 mg
n=129 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=128 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=131 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3
Baseline (n=126,128,131)
|
65.38 units on a scale
Standard Deviation 18.21
|
58.68 units on a scale
Standard Deviation 19.42
|
64.36 units on a scale
Standard Deviation 16.70
|
—
|
|
Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3
Week 2 (n=129,128,123)
|
46.51 units on a scale
Standard Deviation 23.38
|
41.29 units on a scale
Standard Deviation 20.58
|
51.36 units on a scale
Standard Deviation 21.87
|
—
|
|
Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3
Month 1 (n=123,122,123)
|
39.88 units on a scale
Standard Deviation 22.19
|
36.28 units on a scale
Standard Deviation 21.52
|
47.67 units on a scale
Standard Deviation 20.84
|
—
|
|
Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3
Month 3 (n=117,124,116)
|
34.94 units on a scale
Standard Deviation 25.22
|
30.64 units on a scale
Standard Deviation 22.20
|
44.08 units on a scale
Standard Deviation 23.53
|
—
|
SECONDARY outcome
Timeframe: Month 4.5, 6Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Outcome measures
| Measure |
CP-690,550 5 mg
n=110 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=114 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=55 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
n=53 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Physician Global Assessment of Arthritis at Month 4.5 and 6
Month 4.5 (n=110,114,55,53)
|
27.50 units on a scale
Standard Deviation 18.87
|
26.12 units on a scale
Standard Deviation 22.28
|
28.67 units on a scale
Standard Deviation 19.77
|
28.17 units on a scale
Standard Deviation 21.50
|
|
Physician Global Assessment of Arthritis at Month 4.5 and 6
Month 6 (n=101,101,51,48)
|
24.17 units on a scale
Standard Deviation 18.55
|
19.65 units on a scale
Standard Deviation 17.15
|
23.55 units on a scale
Standard Deviation 18.30
|
23.75 units on a scale
Standard Deviation 16.20
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Month 1, 3Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) 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).
Outcome measures
| Measure |
CP-690,550 5 mg
n=133 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=134 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=132 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Baseline:Physical Functioning (n=133,134,132)
|
30.54 units on a scale
Standard Deviation 10.76
|
31.61 units on a scale
Standard Deviation 8.58
|
28.32 units on a scale
Standard Deviation 9.30
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Baseline:Role Physical (n=133,134,132)
|
33.66 units on a scale
Standard Deviation 10.21
|
34.08 units on a scale
Standard Deviation 9.67
|
32.53 units on a scale
Standard Deviation 9.66
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Baseline:Bodily Pain (n=133,134,132)
|
31.09 units on a scale
Standard Deviation 8.13
|
32.55 units on a scale
Standard Deviation 7.45
|
31.95 units on a scale
Standard Deviation 7.70
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Baseline:General Health (n=133,134,132)
|
35.84 units on a scale
Standard Deviation 9.50
|
37.73 units on a scale
Standard Deviation 9.18
|
34.82 units on a scale
Standard Deviation 8.67
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Baseline:Vitality (n=133,134,132)
|
39.71 units on a scale
Standard Deviation 9.87
|
40.11 units on a scale
Standard Deviation 10.26
|
38.41 units on a scale
Standard Deviation 10.77
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Baseline:Social Functioning (n=133,134,132)
|
37.40 units on a scale
Standard Deviation 13.10
|
39.47 units on a scale
Standard Deviation 12.11
|
35.95 units on a scale
Standard Deviation 12.39
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Baseline:Role Emotional (n=133,134,132)
|
37.58 units on a scale
Standard Deviation 14.08
|
36.75 units on a scale
Standard Deviation 13.58
|
35.52 units on a scale
Standard Deviation 14.22
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Baseline:Mental Health (n=133,134,132)
|
40.66 units on a scale
Standard Deviation 11.63
|
41.91 units on a scale
Standard Deviation 11.99
|
39.69 units on a scale
Standard Deviation 12.66
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Baseline:Physical Component Score(n=133,134,132)
|
30.72 units on a scale
Standard Deviation 9.29
|
32.13 units on a scale
Standard Deviation 7.58
|
29.98 units on a scale
Standard Deviation 7.99
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Baseline: Mental Component Score (n=133,134,132)
|
42.82 units on a scale
Standard Deviation 12.69
|
43.24 units on a scale
Standard Deviation 12.81
|
41.34 units on a scale
Standard Deviation 13.25
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Week 2:Physical Functioning (n=130,128,125)
|
33.28 units on a scale
Standard Deviation 11.06
|
34.25 units on a scale
Standard Deviation 9.30
|
30.25 units on a scale
Standard Deviation 10.30
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Week 2:Role Physical (n=130,128,125)
|
36.71 units on a scale
Standard Deviation 10.23
|
38.45 units on a scale
Standard Deviation 9.04
|
36.05 units on a scale
Standard Deviation 10.48
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Week 2:Bodily Pain (n=130,128,125)
|
37.01 units on a scale
Standard Deviation 9.34
|
38.42 units on a scale
Standard Deviation 7.70
|
33.77 units on a scale
Standard Deviation 7.80
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Week 2:General Health (n=130,128,125)
|
37.38 units on a scale
Standard Deviation 8.52
|
38.57 units on a scale
Standard Deviation 8.61
|
35.85 units on a scale
Standard Deviation 8.76
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Week 2:Vitality (n=130,128,125)
|
43.02 units on a scale
Standard Deviation 10.18
|
43.89 units on a scale
Standard Deviation 10.71
|
41.11 units on a scale
Standard Deviation 10.62
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Week 2:Social Functioning (n=130,128,125)
|
41.18 units on a scale
Standard Deviation 12.79
|
42.29 units on a scale
Standard Deviation 11.29
|
38.08 units on a scale
Standard Deviation 12.18
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Week 2:Role Emotional (n=130,128,125)
|
40.54 units on a scale
Standard Deviation 12.94
|
40.62 units on a scale
Standard Deviation 11.99
|
37.69 units on a scale
Standard Deviation 13.49
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Week 2:Mental Health (n=130,128,125)
|
43.72 units on a scale
Standard Deviation 11.48
|
44.25 units on a scale
Standard Deviation 11.19
|
42.07 units on a scale
Standard Deviation 12.31
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Week 2:Physical Component Score (n=130,128,125)
|
34.04 units on a scale
Standard Deviation 9.51
|
35.69 units on a scale
Standard Deviation 7.74
|
31.99 units on a scale
Standard Deviation 8.58
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Week 2:Mental Component Score (n=130,128,125)
|
45.77 units on a scale
Standard Deviation 11.93
|
45.98 units on a scale
Standard Deviation 11.95
|
43.57 units on a scale
Standard Deviation 12.74
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Month 1:Physical Functioning (n=124,123,123)
|
33.56 units on a scale
Standard Deviation 11.14
|
35.64 units on a scale
Standard Deviation 10.06
|
31.01 units on a scale
Standard Deviation 10.15
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Month 1: Role Physical (n=124,123,123)
|
38.25 units on a scale
Standard Deviation 10.06
|
39.59 units on a scale
Standard Deviation 9.98
|
36.33 units on a scale
Standard Deviation 10.56
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Month 1:General Health (n=124,123,123)
|
38.09 units on a scale
Standard Deviation 9.32
|
39.82 units on a scale
Standard Deviation 9.25
|
36.64 units on a scale
Standard Deviation 8.75
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Month 1:Social Functioning (n=124,123,123)
|
40.96 units on a scale
Standard Deviation 11.62
|
44.12 units on a scale
Standard Deviation 11.65
|
39.00 units on a scale
Standard Deviation 12.49
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Month 1:Role Emotional (n=124,123,123)
|
41.05 units on a scale
Standard Deviation 13.23
|
40.84 units on a scale
Standard Deviation 12.86
|
38.87 units on a scale
Standard Deviation 12.84
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Month 1:Mental Health (n=124,123,123)
|
44.13 units on a scale
Standard Deviation 11.68
|
46.18 units on a scale
Standard Deviation 11.64
|
42.89 units on a scale
Standard Deviation 11.92
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Month 1:Physical Component Score (n=124,123,123)
|
34.88 units on a scale
Standard Deviation 9.24
|
37.07 units on a scale
Standard Deviation 8.40
|
32.72 units on a scale
Standard Deviation 9.18
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Month 1:Mental Component Score (n=124,123,123)
|
46.13 units on a scale
Standard Deviation 11.94
|
47.28 units on a scale
Standard Deviation 12.47
|
44.53 units on a scale
Standard Deviation 12.42
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Month 3:Physical Functioning (n=118,125,117)
|
34.78 units on a scale
Standard Deviation 11.43
|
36.70 units on a scale
Standard Deviation 10.56
|
30.54 units on a scale
Standard Deviation 10.67
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Month 3: Role Physical (n=118,125,117)
|
38.40 units on a scale
Standard Deviation 10.49
|
40.19 units on a scale
Standard Deviation 10.95
|
35.09 units on a scale
Standard Deviation 10.66
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Month 3:Bodily Pain (n=118,125,117)
|
39.25 units on a scale
Standard Deviation 9.78
|
40.93 units on a scale
Standard Deviation 9.67
|
34.26 units on a scale
Standard Deviation 9.62
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Month 3:General Health (n=118,125,117)
|
39.22 units on a scale
Standard Deviation 9.78
|
40.21 units on a scale
Standard Deviation 9.46
|
35.30 units on a scale
Standard Deviation 9.30
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Month 3:Vitality (n=118,125,117)
|
45.23 units on a scale
Standard Deviation 10.89
|
46.23 units on a scale
Standard Deviation 11.73
|
40.30 units on a scale
Standard Deviation 11.71
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Month 3:Mental Health (n=118,125,117)
|
44.58 units on a scale
Standard Deviation 11.95
|
45.83 units on a scale
Standard Deviation 11.59
|
40.89 units on a scale
Standard Deviation 12.46
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Month 3:Mental Component Score (n=118,125,116)
|
46.40 units on a scale
Standard Deviation 11.87
|
47.37 units on a scale
Standard Deviation 12.01
|
41.91 units on a scale
Standard Deviation 12.85
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Month 1:Bodily Pain(n=124,123,123)
|
37.50 units on a scale
Standard Deviation 9.45
|
40.02 units on a scale
Standard Deviation 8.42
|
35.35 units on a scale
Standard Deviation 8.77
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Month 1:Vitality (n=124,123,123)
|
44.33 units on a scale
Standard Deviation 9.35
|
45.65 units on a scale
Standard Deviation 11.47
|
41.85 units on a scale
Standard Deviation 11.50
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Month 3:Social Functioning (n=118,125,117)
|
41.91 units on a scale
Standard Deviation 12.37
|
44.49 units on a scale
Standard Deviation 11.21
|
37.74 units on a scale
Standard Deviation 12.12
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Month 3:Role Emotional (n=118,125,116)
|
41.21 units on a scale
Standard Deviation 12.57
|
41.84 units on a scale
Standard Deviation 12.67
|
36.16 units on a scale
Standard Deviation 14.50
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Month 3:Physical Component Score (n=118,125,116)
|
36.18 units on a scale
Standard Deviation 9.96
|
38.01 units on a scale
Standard Deviation 9.35
|
32.38 units on a scale
Standard Deviation 9.35
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) 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).
Outcome measures
| Measure |
CP-690,550 5 mg
n=104 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=103 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=51 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
n=49 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
36-Item Short-Form Health Survey (SF-36) at Month 6
Month 6:Physical Functioning
|
35.62 units on a scale
Standard Deviation 11.63
|
38.47 units on a scale
Standard Deviation 10.14
|
35.00 units on a scale
Standard Deviation 10.31
|
33.97 units on a scale
Standard Deviation 10.58
|
|
36-Item Short-Form Health Survey (SF-36) at Month 6
Month 6: Role Physical
|
40.72 units on a scale
Standard Deviation 9.95
|
43.51 units on a scale
Standard Deviation 11.21
|
39.54 units on a scale
Standard Deviation 10.55
|
38.02 units on a scale
Standard Deviation 9.81
|
|
36-Item Short-Form Health Survey (SF-36) at Month 6
Month 6:Bodily Pain
|
41.53 units on a scale
Standard Deviation 9.61
|
43.63 units on a scale
Standard Deviation 9.27
|
42.40 units on a scale
Standard Deviation 10.22
|
39.60 units on a scale
Standard Deviation 9.01
|
|
36-Item Short-Form Health Survey (SF-36) at Month 6
Month 6:Vitality
|
46.49 units on a scale
Standard Deviation 9.82
|
47.59 units on a scale
Standard Deviation 10.93
|
45.09 units on a scale
Standard Deviation 12.26
|
44.26 units on a scale
Standard Deviation 8.73
|
|
36-Item Short-Form Health Survey (SF-36) at Month 6
Month 6:Social Functioning
|
44.05 units on a scale
Standard Deviation 10.93
|
44.66 units on a scale
Standard Deviation 11.92
|
43.33 units on a scale
Standard Deviation 12.27
|
40.38 units on a scale
Standard Deviation 11.11
|
|
36-Item Short-Form Health Survey (SF-36) at Month 6
Month 6:Role Emotional
|
42.36 units on a scale
Standard Deviation 13.34
|
45.06 units on a scale
Standard Deviation 12.27
|
41.07 units on a scale
Standard Deviation 13.18
|
39.53 units on a scale
Standard Deviation 12.93
|
|
36-Item Short-Form Health Survey (SF-36) at Month 6
Month 6:General Health
|
39.49 units on a scale
Standard Deviation 9.54
|
41.68 units on a scale
Standard Deviation 10.35
|
38.95 units on a scale
Standard Deviation 9.51
|
37.89 units on a scale
Standard Deviation 8.45
|
|
36-Item Short-Form Health Survey (SF-36) at Month 6
Month 6:Mental Health
|
45.29 units on a scale
Standard Deviation 12.12
|
47.48 units on a scale
Standard Deviation 11.61
|
44.85 units on a scale
Standard Deviation 14.61
|
46.19 units on a scale
Standard Deviation 9.65
|
|
36-Item Short-Form Health Survey (SF-36) at Month 6
Month 6:Physical Component Score
|
37.78 units on a scale
Standard Deviation 9.20
|
40.21 units on a scale
Standard Deviation 9.24
|
37.84 units on a scale
Standard Deviation 9.59
|
35.43 units on a scale
Standard Deviation 8.69
|
|
36-Item Short-Form Health Survey (SF-36) at Month 6
Month 6:Mental Component Score
|
47.41 units on a scale
Standard Deviation 12.32
|
48.83 units on a scale
Standard Deviation 12.65
|
46.17 units on a scale
Standard Deviation 15.06
|
46.03 units on a scale
Standard Deviation 11.52
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Month 1, 3Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem.Except adequacy,optimal sleep and quantity,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.
Outcome measures
| Measure |
CP-690,550 5 mg
n=133 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=133 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=130 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Week 2: Sleep Adequacy (n=129,127,125)
|
48.06 units on a scale
Standard Deviation 28.70
|
44.17 units on a scale
Standard Deviation 28.35
|
42.72 units on a scale
Standard Deviation 26.77
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Baseline: Overall Sleep Problem (n=133,132,129)
|
43.10 units on a scale
Standard Deviation 21.00
|
41.57 units on a scale
Standard Deviation 17.88
|
46.08 units on a scale
Standard Deviation 20.73
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Baseline: Sleep Adequacy (n=133,133,129)
|
46.39 units on a scale
Standard Deviation 27.89
|
43.16 units on a scale
Standard Deviation 25.89
|
39.53 units on a scale
Standard Deviation 27.95
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Baseline: Sleep Disturbance (n=133,133,129)
|
47.43 units on a scale
Standard Deviation 28.39
|
43.20 units on a scale
Standard Deviation 24.83
|
47.98 units on a scale
Standard Deviation 27.00
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Baseline: Snoring (n=131,131,127)
|
42.14 units on a scale
Standard Deviation 31.89
|
37.10 units on a scale
Standard Deviation 33.75
|
40.00 units on a scale
Standard Deviation 33.62
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Week 2: Overall Sleep Problem (n=129,127,124)
|
38.04 units on a scale
Standard Deviation 20.78
|
37.69 units on a scale
Standard Deviation 18.83
|
41.47 units on a scale
Standard Deviation 20.01
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Week 2: Awakened Short of Breath (n=129,127,125)
|
17.83 units on a scale
Standard Deviation 25.28
|
17.32 units on a scale
Standard Deviation 21.58
|
18.72 units on a scale
Standard Deviation 25.75
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Week 2: Sleep Disturbance (n=129,127,125)
|
39.59 units on a scale
Standard Deviation 28.24
|
36.41 units on a scale
Standard Deviation 22.89
|
42.28 units on a scale
Standard Deviation 26.45
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Week 2: Sleep Quantity (n=129,127,124)
|
6.40 units on a scale
Standard Deviation 1.57
|
6.68 units on a scale
Standard Deviation 1.41
|
6.48 units on a scale
Standard Deviation 1.75
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Week 2: Snoring (n=128,125,122)
|
36.25 units on a scale
Standard Deviation 34.21
|
35.84 units on a scale
Standard Deviation 34.48
|
40.49 units on a scale
Standard Deviation 32.67
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Month 1: Sleep Problem Summary (n=124,123,123)
|
36.21 units on a scale
Standard Deviation 20.69
|
34.53 units on a scale
Standard Deviation 20.08
|
37.37 units on a scale
Standard Deviation 20.42
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Month 1: Overall Sleep Problem (n=124,123,123)
|
37.23 units on a scale
Standard Deviation 20.70
|
35.40 units on a scale
Standard Deviation 19.94
|
38.79 units on a scale
Standard Deviation 20.58
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Month 1: Awakened Short of Breath (n=124,123,123)
|
15.81 units on a scale
Standard Deviation 21.53
|
15.45 units on a scale
Standard Deviation 23.16
|
19.84 units on a scale
Standard Deviation 26.30
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Month 1: Sleep Disturbance (n=124,123,123)
|
39.12 units on a scale
Standard Deviation 28.16
|
34.82 units on a scale
Standard Deviation 25.12
|
39.64 units on a scale
Standard Deviation 26.26
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Month 1: Sleep Quantity (n=124,123,123)
|
6.59 units on a scale
Standard Deviation 1.34
|
6.80 units on a scale
Standard Deviation 1.43
|
6.43 units on a scale
Standard Deviation 1.42
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Month 1: Snoring (n=124,122,120)
|
36.13 units on a scale
Standard Deviation 33.42
|
34.10 units on a scale
Standard Deviation 32.80
|
41.50 units on a scale
Standard Deviation 33.12
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Month 1: Somnolence (n=124,123,123)
|
30.91 units on a scale
Standard Deviation 22.30
|
30.84 units on a scale
Standard Deviation 23.97
|
34.91 units on a scale
Standard Deviation 23.67
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Month 3: Sleep Problem Summary (n=117,125,117)
|
36.81 units on a scale
Standard Deviation 21.10
|
35.68 units on a scale
Standard Deviation 19.36
|
40.14 units on a scale
Standard Deviation 20.20
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Month 3: Overall Sleep Problem (n=117,125,117)
|
37.23 units on a scale
Standard Deviation 20.72
|
36.08 units on a scale
Standard Deviation 19.40
|
42.00 units on a scale
Standard Deviation 20.41
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Month 3: Sleep Adequacy (n=118,125,117)
|
48.64 units on a scale
Standard Deviation 30.32
|
48.56 units on a scale
Standard Deviation 29.04
|
43.68 units on a scale
Standard Deviation 27.47
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Month 3: Awakened Short of Breath (n=118,125,117)
|
18.14 units on a scale
Standard Deviation 23.68
|
19.68 units on a scale
Standard Deviation 24.09
|
17.95 units on a scale
Standard Deviation 24.27
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Month 3: Sleep Disturbance (n=118,125,117)
|
38.44 units on a scale
Standard Deviation 28.37
|
34.61 units on a scale
Standard Deviation 23.21
|
43.27 units on a scale
Standard Deviation 26.45
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Month 3: Sleep Quantity (n=117,124,117)
|
6.58 units on a scale
Standard Deviation 1.50
|
6.71 units on a scale
Standard Deviation 1.42
|
6.27 units on a scale
Standard Deviation 1.49
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Month 3: Snoring (n=118,123,117)
|
36.44 units on a scale
Standard Deviation 32.83
|
36.26 units on a scale
Standard Deviation 32.63
|
41.37 units on a scale
Standard Deviation 31.92
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Month 3: Somnolence (n=117,125,117)
|
30.14 units on a scale
Standard Deviation 23.53
|
31.31 units on a scale
Standard Deviation 23.68
|
36.47 units on a scale
Standard Deviation 23.10
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Baseline: Sleep Problem Summary (n=133,132,129)
|
40.55 units on a scale
Standard Deviation 21.13
|
39.87 units on a scale
Standard Deviation 18.03
|
44.65 units on a scale
Standard Deviation 20.56
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Baseline: Awakened Short of Breath (n=133,133,130)
|
16.99 units on a scale
Standard Deviation 24.56
|
19.10 units on a scale
Standard Deviation 24.10
|
21.54 units on a scale
Standard Deviation 26.19
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Baseline: Sleep Quantity (n=132,131,129)
|
6.47 units on a scale
Standard Deviation 1.55
|
6.44 units on a scale
Standard Deviation 1.35
|
6.33 units on a scale
Standard Deviation 1.46
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Baseline: Somnolence (n=133,132,129)
|
36.39 units on a scale
Standard Deviation 22.47
|
34.19 units on a scale
Standard Deviation 22.83
|
38.55 units on a scale
Standard Deviation 23.60
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Week 2: Sleep Problem Summary (n=129,127,125)
|
36.87 units on a scale
Standard Deviation 20.84
|
37.03 units on a scale
Standard Deviation 18.97
|
40.35 units on a scale
Standard Deviation 20.10
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Week 2: Somnolence (n=129,127,124)
|
31.78 units on a scale
Standard Deviation 21.85
|
32.18 units on a scale
Standard Deviation 23.47
|
36.45 units on a scale
Standard Deviation 23.18
|
—
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Month 1: Sleep Adequacy (n=124,123,123)
|
49.84 units on a scale
Standard Deviation 28.31
|
48.13 units on a scale
Standard Deviation 29.35
|
49.11 units on a scale
Standard Deviation 28.86
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem.Except adequacy,optimal sleep and quantity,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.
Outcome measures
| Measure |
CP-690,550 5 mg
n=104 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=102 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=49 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
n=49 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6
Month 6: Sleep Problem Summary
|
35.32 units on a scale
Standard Deviation 21.46
|
32.03 units on a scale
Standard Deviation 18.42
|
38.78 units on a scale
Standard Deviation 20.81
|
35.35 units on a scale
Standard Deviation 19.05
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6
Month 6: Overall Sleep Problem
|
35.75 units on a scale
Standard Deviation 20.68
|
32.92 units on a scale
Standard Deviation 18.33
|
39.73 units on a scale
Standard Deviation 20.85
|
36.02 units on a scale
Standard Deviation 18.45
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6
Month 6: Sleep Adequacy
|
50.48 units on a scale
Standard Deviation 30.64
|
52.75 units on a scale
Standard Deviation 28.46
|
43.47 units on a scale
Standard Deviation 30.99
|
50.42 units on a scale
Standard Deviation 26.89
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6
Month 6: Awakened Short of Breath
|
16.73 units on a scale
Standard Deviation 24.15
|
14.12 units on a scale
Standard Deviation 22.62
|
18.37 units on a scale
Standard Deviation 21.54
|
17.92 units on a scale
Standard Deviation 21.13
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6
Month 6: Sleep Disturbance
|
36.84 units on a scale
Standard Deviation 26.19
|
33.88 units on a scale
Standard Deviation 23.51
|
40.92 units on a scale
Standard Deviation 26.89
|
35.10 units on a scale
Standard Deviation 25.26
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6
Month 6: Somnolence
|
29.74 units on a scale
Standard Deviation 22.24
|
26.14 units on a scale
Standard Deviation 19.40
|
30.61 units on a scale
Standard Deviation 22.56
|
33.19 units on a scale
Standard Deviation 20.09
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6
Month 6: Sleep Quantity
|
6.56 units on a scale
Standard Deviation 1.45
|
6.93 units on a scale
Standard Deviation 1.29
|
6.27 units on a scale
Standard Deviation 1.29
|
6.80 units on a scale
Standard Deviation 1.26
|
|
Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6
Month 6: Snoring
|
34.62 units on a scale
Standard Deviation 31.80
|
35.84 units on a scale
Standard Deviation 31.79
|
37.96 units on a scale
Standard Deviation 31.95
|
38.75 units on a scale
Standard Deviation 32.59
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Month 1, 3Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. Number of participants with optimal sleep is reported.
Outcome measures
| Measure |
CP-690,550 5 mg
n=133 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=134 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=132 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3
Month 3 (n= 118, 125, 118)
|
53 participants
|
56 participants
|
47 participants
|
—
|
|
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3
Baseline (n= 133, 134, 132)
|
53 participants
|
59 participants
|
48 participants
|
—
|
|
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3
Week 2 (n= 130, 128, 126)
|
52 participants
|
62 participants
|
50 participants
|
—
|
|
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3
Month 1 (n= 124, 123, 124)
|
59 participants
|
58 participants
|
53 participants
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. Number of participants with optimal sleep is reported.
Outcome measures
| Measure |
CP-690,550 5 mg
n=104 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=103 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=51 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
n=49 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6
|
50 participants
|
57 participants
|
21 participants
|
24 participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
FACIT-Fatigue Scale (FS):13-item questionnaire, participant scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS 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.
Outcome measures
| Measure |
CP-690,550 5 mg
n=132 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=134 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=129 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3
Baseline (n=132,134,129)
|
27.84 units on a scale
Standard Deviation 11.12
|
29.48 units on a scale
Standard Deviation 11.39
|
26.98 units on a scale
Standard Deviation 11.52
|
—
|
|
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3
Month 3 (n=118,125,117)
|
33.30 units on a scale
Standard Deviation 11.72
|
33.66 units on a scale
Standard Deviation 12.27
|
27.93 units on a scale
Standard Deviation 12.36
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
FACIT-FS:13-item questionnaire, participant scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS 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.
Outcome measures
| Measure |
CP-690,550 5 mg
n=104 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=102 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=51 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
n=49 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6
|
34.69 units on a scale
Standard Deviation 10.81
|
35.98 units on a scale
Standard Deviation 11.55
|
33.57 units on a scale
Standard Deviation 12.21
|
31.63 units on a scale
Standard Deviation 10.16
|
SECONDARY outcome
Timeframe: Baseline, Month 1, 3Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
CP-690,550 5 mg
n=131 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=134 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=129 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3
Baseline (n=131,134,129)
|
0.38 units on a scale
Standard Deviation 0.34
|
0.47 units on a scale
Standard Deviation 0.32
|
0.38 units on a scale
Standard Deviation 0.33
|
—
|
|
Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3
Month 1 (n=122,121,120)
|
0.56 units on a scale
Standard Deviation 0.28
|
0.63 units on a scale
Standard Deviation 0.24
|
0.49 units on a scale
Standard Deviation 0.30
|
—
|
|
Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3
Month 3 (n=117,123,117)
|
0.55 units on a scale
Standard Deviation 0.30
|
0.62 units on a scale
Standard Deviation 0.25
|
0.43 units on a scale
Standard Deviation 0.35
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
CP-690,550 5 mg
n=104 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=101 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=51 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
n=49 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Euro Quality of Life - 5 Dimensions (EQ-5D) - Health State Profile Utility Score at Month 6
|
0.62 units on a scale
Standard Deviation 0.28
|
0.68 units on a scale
Standard Deviation 0.24
|
0.60 units on a scale
Standard Deviation 0.24
|
0.55 units on a scale
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.
Outcome measures
| Measure |
CP-690,550 5 mg
n=133 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=134 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=130 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Baseline: Work disabled due to RA (n=83,77,79)
|
1.46 units on a scale
Standard Deviation 0.50
|
1.55 units on a scale
Standard Deviation 0.50
|
1.48 units on a scale
Standard Deviation 0.50
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Baseline: Sick leave due to RA (n=104,109,100)
|
1.83 units on a scale
Standard Deviation 0.38
|
1.80 units on a scale
Standard Deviation 0.40
|
1.71 units on a scale
Standard Deviation 0.46
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Baseline: Seen any doctor (n=133,133,130)
|
1.11 units on a scale
Standard Deviation 0.31
|
1.09 units on a scale
Standard Deviation 0.29
|
1.15 units on a scale
Standard Deviation 0.35
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Baseline: Treated in ER (n=133,134,130)
|
1.89 units on a scale
Standard Deviation 0.32
|
1.96 units on a scale
Standard Deviation 0.19
|
1.93 units on a scale
Standard Deviation 0.25
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Baseline: Admitted for overnight stay (n=16,6,9)
|
0.19 units on a scale
Standard Deviation 0.54
|
0.17 units on a scale
Standard Deviation 0.41
|
0.33 units on a scale
Standard Deviation 0.71
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Baseline: Hospitalization (n=133,134,130)
|
1.97 units on a scale
Standard Deviation 0.17
|
1.97 units on a scale
Standard Deviation 0.17
|
1.95 units on a scale
Standard Deviation 0.23
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Baseline: Had outpatient surgeries (n=133,134,130)
|
1.95 units on a scale
Standard Deviation 0.21
|
1.97 units on a scale
Standard Deviation 0.17
|
1.93 units on a scale
Standard Deviation 0.25
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Baseline:Non-study diagnostic tests(n=133,134,130)
|
1.74 units on a scale
Standard Deviation 0.44
|
1.75 units on a scale
Standard Deviation 0.43
|
1.74 units on a scale
Standard Deviation 0.44
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Baseline: In nursing home (n=133,134,130)
|
1.99 units on a scale
Standard Deviation 0.09
|
1.99 units on a scale
Standard Deviation 0.09
|
1.99 units on a scale
Standard Deviation 0.09
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Baseline: Home HC services (n=133,134,130)
|
1.98 units on a scale
Standard Deviation 0.12
|
1.99 units on a scale
Standard Deviation 0.09
|
1.96 units on a scale
Standard Deviation 0.19
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Baseline: Home healthcare services (n=2,2,5)
|
1.50 units on a scale
Standard Deviation 0.71
|
0.50 units on a scale
Standard Deviation 0.71
|
0.80 units on a scale
Standard Deviation 0.84
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Baseline:Required aids/devices (n=133,134,130)
|
1.77 units on a scale
Standard Deviation 0.42
|
1.86 units on a scale
Standard Deviation 0.35
|
1.82 units on a scale
Standard Deviation 0.39
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Baseline: Seen NM practitioner (n=133,134,130)
|
1.97 units on a scale
Standard Deviation 0.17
|
1.96 units on a scale
Standard Deviation 0.21
|
1.96 units on a scale
Standard Deviation 0.19
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Baseline: Currently employed (n=132,134,130)
|
1.70 units on a scale
Standard Deviation 0.46
|
1.66 units on a scale
Standard Deviation 0.48
|
1.68 units on a scale
Standard Deviation 0.47
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Baseline: Feel well enough to work (n=84,78,83)
|
1.85 units on a scale
Standard Deviation 0.36
|
1.82 units on a scale
Standard Deviation 0.39
|
1.82 units on a scale
Standard Deviation 0.39
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Baseline: Retired (n=85,80,86)
|
1.49 units on a scale
Standard Deviation 0.50
|
1.43 units on a scale
Standard Deviation 0.50
|
1.49 units on a scale
Standard Deviation 0.50
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Baseline: Lost job/retired early (n=83,77,80)
|
1.58 units on a scale
Standard Deviation 0.50
|
1.69 units on a scale
Standard Deviation 0.47
|
1.55 units on a scale
Standard Deviation 0.50
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Baseline: Unable to work due to RA (n=84,77,83)
|
1.36 units on a scale
Standard Deviation 0.48
|
1.48 units on a scale
Standard Deviation 0.50
|
1.40 units on a scale
Standard Deviation 0.49
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Baseline: Performed part time work (n=103,108,100)
|
1.94 units on a scale
Standard Deviation 0.24
|
1.94 units on a scale
Standard Deviation 0.25
|
1.88 units on a scale
Standard Deviation 0.33
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Baseline: Performed paid work (n=102,109,98)
|
1.65 units on a scale
Standard Deviation 0.48
|
1.63 units on a scale
Standard Deviation 0.48
|
1.65 units on a scale
Standard Deviation 0.48
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Baseline: Unable to do chores (n=130,130,126)
|
1.37 units on a scale
Standard Deviation 0.48
|
1.42 units on a scale
Standard Deviation 0.49
|
1.27 units on a scale
Standard Deviation 0.45
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Baseline: Chores by housekeeper (n=130,134,130)
|
1.85 units on a scale
Standard Deviation 0.36
|
1.86 units on a scale
Standard Deviation 0.35
|
1.82 units on a scale
Standard Deviation 0.39
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Baseline: Chores by family/friends (n=131,134,130)
|
1.44 units on a scale
Standard Deviation 0.50
|
1.49 units on a scale
Standard Deviation 0.50
|
1.48 units on a scale
Standard Deviation 0.50
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Month 3: Seen any doctor (n=117,125,117)
|
1.23 units on a scale
Standard Deviation 0.42
|
1.21 units on a scale
Standard Deviation 0.41
|
1.21 units on a scale
Standard Deviation 0.41
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Month 3: Treated in ER (n=116,125,117)
|
1.94 units on a scale
Standard Deviation 0.24
|
1.94 units on a scale
Standard Deviation 0.25
|
1.93 units on a scale
Standard Deviation 0.25
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Month 3: Admitted for overnight stay (n=7,8,8)
|
0.29 units on a scale
Standard Deviation 0.76
|
0.00 units on a scale
Standard Deviation 0.00
|
0.13 units on a scale
Standard Deviation 0.35
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Month 3: Hospitalization (n=116,124,117)
|
1.99 units on a scale
Standard Deviation 0.09
|
2.00 units on a scale
Standard Deviation 0.00
|
1.98 units on a scale
Standard Deviation 0.13
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Month 3: Had outpatient surgeries (n=116,125,117)
|
1.94 units on a scale
Standard Deviation 0.24
|
1.98 units on a scale
Standard Deviation 0.15
|
1.97 units on a scale
Standard Deviation 0.18
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Month 3:Non study diagnostic tests (n=116,125,117)
|
1.80 units on a scale
Standard Deviation 0.40
|
1.82 units on a scale
Standard Deviation 0.38
|
1.77 units on a scale
Standard Deviation 0.42
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Month 3: Required aids/devices (n=116,125,117)
|
1.81 units on a scale
Standard Deviation 0.39
|
1.91 units on a scale
Standard Deviation 0.28
|
1.76 units on a scale
Standard Deviation 0.43
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Month 3: Seen NM practitioner (n=116,125,117)
|
1.97 units on a scale
Standard Deviation 0.18
|
1.97 units on a scale
Standard Deviation 0.18
|
1.97 units on a scale
Standard Deviation 0.18
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Month 3: Currently employed (n=115,125,117)
|
1.70 units on a scale
Standard Deviation 0.46
|
1.62 units on a scale
Standard Deviation 0.49
|
1.68 units on a scale
Standard Deviation 0.47
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Month 3: Feel well enough to work (n=68,67,70)
|
1.82 units on a scale
Standard Deviation 0.38
|
1.78 units on a scale
Standard Deviation 0.42
|
1.83 units on a scale
Standard Deviation 0.38
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Month 3: Retired (n=68,66,72)
|
1.56 units on a scale
Standard Deviation 0.50
|
1.36 units on a scale
Standard Deviation 0.48
|
1.53 units on a scale
Standard Deviation 0.50
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Month 3: Lost job/retired early (n=67,68,69)
|
1.70 units on a scale
Standard Deviation 0.46
|
1.69 units on a scale
Standard Deviation 0.47
|
1.59 units on a scale
Standard Deviation 0.49
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Month 3: Unable to work due to RA (n=68,66,71)
|
1.41 units on a scale
Standard Deviation 0.50
|
1.53 units on a scale
Standard Deviation 0.50
|
1.44 units on a scale
Standard Deviation 0.50
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Month 3: Work disabled due to RA (n=67,67,69)
|
1.48 units on a scale
Standard Deviation 0.50
|
1.57 units on a scale
Standard Deviation 0.50
|
1.54 units on a scale
Standard Deviation 0.50
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Month 3: Sick leave due to RA (n=95,100,97)
|
1.88 units on a scale
Standard Deviation 0.32
|
1.86 units on a scale
Standard Deviation 0.35
|
1.82 units on a scale
Standard Deviation 0.38
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Month 3: Performed part time work (n=96,100,96)
|
1.96 units on a scale
Standard Deviation 0.20
|
1.94 units on a scale
Standard Deviation 0.24
|
1.94 units on a scale
Standard Deviation 0.24
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Month 3: Performed paid work (n=96,99,97)
|
1.78 units on a scale
Standard Deviation 0.42
|
1.69 units on a scale
Standard Deviation 0.47
|
1.67 units on a scale
Standard Deviation 0.47
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Month 3: Unable to do chores (n=112,120,113)
|
1.57 units on a scale
Standard Deviation 0.50
|
1.63 units on a scale
Standard Deviation 0.49
|
1.45 units on a scale
Standard Deviation 0.50
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Month 3: Chores by housekeeper (n=116,122,117)
|
1.86 units on a scale
Standard Deviation 0.35
|
1.89 units on a scale
Standard Deviation 0.32
|
1.85 units on a scale
Standard Deviation 0.35
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Month 3: Chores by family/friends (n=116,122,116)
|
1.55 units on a scale
Standard Deviation 0.50
|
1.66 units on a scale
Standard Deviation 0.48
|
1.53 units on a scale
Standard Deviation 0.50
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Month 3: In nursing home (n=116,125,117)
|
1.99 units on a scale
Standard Deviation 0.09
|
1.99 units on a scale
Standard Deviation 0.09
|
1.99 units on a scale
Standard Deviation 0.09
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
Month 3: Home HC services (n=116,123,117)
|
1.97 units on a scale
Standard Deviation 0.16
|
1.99 units on a scale
Standard Deviation 0.09
|
1.97 units on a scale
Standard Deviation 0.16
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Outcome measures
| Measure |
CP-690,550 5 mg
n=103 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=102 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=50 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
n=49 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6: Seen any doctor (n=102,101,50,49)
|
1.29 units on a scale
Standard Deviation 0.46
|
1.22 units on a scale
Standard Deviation 0.41
|
1.20 units on a scale
Standard Deviation 0.40
|
1.27 units on a scale
Standard Deviation 0.45
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6: Treated in ER (n=103,102,50,49)
|
1.96 units on a scale
Standard Deviation 0.19
|
1.93 units on a scale
Standard Deviation 0.25
|
1.94 units on a scale
Standard Deviation 0.24
|
1.98 units on a scale
Standard Deviation 0.14
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6: Admitted for overnight stay (n=5,7,3,1)
|
0.20 units on a scale
Standard Deviation 0.45
|
0.00 units on a scale
Standard Deviation 0.00
|
1.33 units on a scale
Standard Deviation 1.15
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6: Hospitalization (n=102,102,50,49)
|
1.98 units on a scale
Standard Deviation 0.14
|
1.99 units on a scale
Standard Deviation 0.10
|
1.96 units on a scale
Standard Deviation 0.20
|
1.98 units on a scale
Standard Deviation 0.14
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6:Had outpatient surgeries (n=103,102,50,49)
|
2.00 units on a scale
Standard Deviation 0.00
|
1.95 units on a scale
Standard Deviation 0.22
|
1.96 units on a scale
Standard Deviation 0.20
|
1.96 units on a scale
Standard Deviation 0.20
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6:Non-study diagnostic test(n=103,102,50,49)
|
1.85 units on a scale
Standard Deviation 0.35
|
1.84 units on a scale
Standard Deviation 0.37
|
1.74 units on a scale
Standard Deviation 0.44
|
1.86 units on a scale
Standard Deviation 0.35
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6: In nursing home (n=103,102,50,49)
|
1.98 units on a scale
Standard Deviation 0.14
|
2.00 units on a scale
Standard Deviation 0.00
|
2.00 units on a scale
Standard Deviation 0.00
|
1.96 units on a scale
Standard Deviation 0.20
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6: Home HC services (n=101,102,50,49)
|
2.00 units on a scale
Standard Deviation 0.00
|
1.98 units on a scale
Standard Deviation 0.14
|
2.00 units on a scale
Standard Deviation 0.00
|
2.00 units on a scale
Standard Deviation 0.00
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6: Required aids/devices (n=103,102,50,48)
|
1.82 units on a scale
Standard Deviation 0.39
|
1.91 units on a scale
Standard Deviation 0.29
|
1.90 units on a scale
Standard Deviation 0.30
|
1.83 units on a scale
Standard Deviation 0.38
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6: Seen NM practitioner (n=103,102,50,49)
|
1.99 units on a scale
Standard Deviation 0.10
|
1.96 units on a scale
Standard Deviation 0.20
|
1.98 units on a scale
Standard Deviation 0.14
|
1.96 units on a scale
Standard Deviation 0.20
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6: Currently employed (n=103,102,50,49)
|
1.67 units on a scale
Standard Deviation 0.47
|
1.63 units on a scale
Standard Deviation 0.49
|
1.60 units on a scale
Standard Deviation 0.49
|
1.71 units on a scale
Standard Deviation 0.46
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6: Feel well enough to work (n=62,57,27,32)
|
1.81 units on a scale
Standard Deviation 0.40
|
1.68 units on a scale
Standard Deviation 0.47
|
1.70 units on a scale
Standard Deviation 0.47
|
1.88 units on a scale
Standard Deviation 0.34
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6: Retired (n=62,56,28,31)
|
1.45 units on a scale
Standard Deviation 0.50
|
1.36 units on a scale
Standard Deviation 0.48
|
1.43 units on a scale
Standard Deviation 0.50
|
1.39 units on a scale
Standard Deviation 0.50
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6: Lost job/retired early (n=62,54,27,32)
|
1.71 units on a scale
Standard Deviation 0.46
|
1.74 units on a scale
Standard Deviation 0.44
|
1.59 units on a scale
Standard Deviation 0.50
|
1.44 units on a scale
Standard Deviation 0.50
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6: Unable to work due to RA (n=62,55,27,32)
|
1.48 units on a scale
Standard Deviation 0.50
|
1.67 units on a scale
Standard Deviation 0.47
|
1.56 units on a scale
Standard Deviation 0.51
|
1.41 units on a scale
Standard Deviation 0.50
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6: Work disabled due to RA (n=61,53,27,32)
|
1.57 units on a scale
Standard Deviation 0.50
|
1.70 units on a scale
Standard Deviation 0.46
|
1.56 units on a scale
Standard Deviation 0.51
|
1.50 units on a scale
Standard Deviation 0.51
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6: Sick leave due to RA (n=85,84,41,37)
|
1.92 units on a scale
Standard Deviation 0.28
|
1.88 units on a scale
Standard Deviation 0.33
|
1.88 units on a scale
Standard Deviation 0.33
|
1.86 units on a scale
Standard Deviation 0.35
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6: Performed part time work (n=85,84,40,36)
|
1.96 units on a scale
Standard Deviation 0.19
|
1.95 units on a scale
Standard Deviation 0.21
|
2.00 units on a scale
Standard Deviation 0.00
|
1.92 units on a scale
Standard Deviation 0.28
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6: Performed paid work (n=83,84,40,36)
|
1.71 units on a scale
Standard Deviation 0.46
|
1.75 units on a scale
Standard Deviation 0.44
|
1.65 units on a scale
Standard Deviation 0.48
|
1.64 units on a scale
Standard Deviation 0.49
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6: Unable to do chores (n=101,98,49,48)
|
1.65 units on a scale
Standard Deviation 0.48
|
1.73 units on a scale
Standard Deviation 0.44
|
1.51 units on a scale
Standard Deviation 0.51
|
1.44 units on a scale
Standard Deviation 0.50
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6: Chores by housekeeper (n=103,99,50,49)
|
1.92 units on a scale
Standard Deviation 0.27
|
1.91 units on a scale
Standard Deviation 0.29
|
1.82 units on a scale
Standard Deviation 0.39
|
1.90 units on a scale
Standard Deviation 0.31
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6: Chores by family/friends (n=103,99,50,49)
|
1.69 units on a scale
Standard Deviation 0.47
|
1.77 units on a scale
Standard Deviation 0.42
|
1.62 units on a scale
Standard Deviation 0.49
|
1.55 units on a scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Outcome measures
| Measure |
CP-690,550 5 mg
n=119 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=121 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=111 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Baseline: Doctor visit (n=119,121,111)
|
5.07 number of events
Standard Deviation 5.00
|
5.09 number of events
Standard Deviation 5.10
|
4.58 number of events
Standard Deviation 3.82
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Baseline: NM practitioner visits (n=4,6,5)
|
5.75 number of events
Standard Deviation 4.35
|
4.83 number of events
Standard Deviation 3.25
|
21.40 number of events
Standard Deviation 29.75
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Baseline: Hospital ER visit (n=14,5,9)
|
1.79 number of events
Standard Deviation 1.53
|
2.00 number of events
Standard Deviation 1.73
|
1.22 number of events
Standard Deviation 0.44
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Baseline: Hospitalization (n=4,4,7)
|
1.25 number of events
Standard Deviation 0.50
|
1.00 number of events
Standard Deviation 0.00
|
1.14 number of events
Standard Deviation 0.38
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Baseline: Outpatient surgery (n=6,4,8)
|
1.17 number of events
Standard Deviation 0.41
|
1.00 number of events
Standard Deviation 0.00
|
1.00 number of events
Standard Deviation 0.00
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Baseline: Non-study diagnostic tests (n=34,32,32)
|
1.85 number of events
Standard Deviation 1.02
|
2.06 number of events
Standard Deviation 1.72
|
1.69 number of events
Standard Deviation 0.97
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Baseline: RA related doctor visit (n=117,120,111)
|
1.46 number of events
Standard Deviation 0.91
|
1.18 number of events
Standard Deviation 0.84
|
1.44 number of events
Standard Deviation 0.93
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Baseline: RA related ER visit (n=15,6,9)
|
0.67 number of events
Standard Deviation 0.90
|
0.67 number of events
Standard Deviation 0.82
|
0.89 number of events
Standard Deviation 0.93
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Baseline: RA related diagnostic test (n=35,33,34)
|
0.71 number of events
Standard Deviation 0.83
|
0.79 number of events
Standard Deviation 1.14
|
0.82 number of events
Standard Deviation 0.76
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Baseline: RA related hospitalization (n=4,5,7)
|
0.75 number of events
Standard Deviation 0.96
|
0.80 number of events
Standard Deviation 1.10
|
0.86 number of events
Standard Deviation 0.69
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Baseline: RA related outpatient surgery (n=6,5,9)
|
0.33 number of events
Standard Deviation 0.82
|
0.80 number of events
Standard Deviation 0.84
|
0.89 number of events
Standard Deviation 0.93
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Baselin:RA related NM visit (n=4,7,5)
|
1.25 number of events
Standard Deviation 0.96
|
0.57 number of events
Standard Deviation 0.53
|
1.00 number of events
Standard Deviation 1.00
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Month 3: Doctor visit (n=89,99,93)
|
3.30 number of events
Standard Deviation 2.91
|
3.69 number of events
Standard Deviation 3.73
|
4.04 number of events
Standard Deviation 4.59
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Month 3: NM practitioners visits (n=4,4,4)
|
36.25 number of events
Standard Deviation 40.25
|
5.00 number of events
Standard Deviation 2.00
|
8.75 number of events
Standard Deviation 10.63
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Month 3: Hospital ER visit (n=7,8,8)
|
1.00 number of events
Standard Deviation 0.00
|
1.38 number of events
Standard Deviation 1.06
|
1.38 number of events
Standard Deviation 0.74
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Month 3: Hospitalization (n=1,0,2)
|
1.00 number of events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
NA number of events
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
1.00 number of events
Standard Deviation 0.00
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Month 3: Outpatient surgery (n=7,3,4)
|
1.14 number of events
Standard Deviation 0.38
|
1.00 number of events
Standard Deviation 0.00
|
1.00 number of events
Standard Deviation 0.00
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Month 3: Non-study diagnostic tests (n=22,22,26)
|
1.82 number of events
Standard Deviation 1.65
|
1.14 number of events
Standard Deviation 0.35
|
1.62 number of events
Standard Deviation 1.27
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Month 3: RA related doctor visit (n=90,98,93)
|
1.16 number of events
Standard Deviation 1.08
|
0.82 number of events
Standard Deviation 0.65
|
1.13 number of events
Standard Deviation 0.92
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Month 3: RA related ER visit (n=7,8,8)
|
0.43 number of events
Standard Deviation 0.79
|
0.00 number of events
Standard Deviation 0.00
|
0.75 number of events
Standard Deviation 1.39
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Month 3: RA related diagnostic test (n=23,22,26)
|
0.30 number of events
Standard Deviation 0.47
|
0.23 number of events
Standard Deviation 0.43
|
0.35 number of events
Standard Deviation 0.56
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Month 3: RA related hospitalization (n=1,0,2)
|
0.00 number of events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
NA number of events
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
0.00 number of events
Standard Deviation 0.00
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Month 3:RA related outpatient surgery (n=7,3,4)
|
0.43 number of events
Standard Deviation 0.79
|
0.67 number of events
Standard Deviation 1.15
|
1.00 number of events
Standard Deviation 1.15
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Month 3:RA related NM visit (n=4,4,4)
|
0.75 number of events
Standard Deviation 0.96
|
1.25 number of events
Standard Deviation 0.96
|
1.25 number of events
Standard Deviation 0.96
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Outcome measures
| Measure |
CP-690,550 5 mg
n=73 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=80 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=40 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
n=36 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
Month 6: NM practitioner visit (n=1,4,1,2)
|
5.00 number of events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
15.50 number of events
Standard Deviation 10.63
|
20.00 number of events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
4.00 number of events
Standard Deviation 0.00
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
Month 6: Outpatient surgery (n=0,5,2,2)
|
NA number of events
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
1.00 number of events
Standard Deviation 0.00
|
2.50 number of events
Standard Deviation 0.71
|
1.50 number of events
Standard Deviation 0.71
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
Month 6: Non-study diagnostic test (n=15,16,13,7)
|
2.07 number of events
Standard Deviation 2.02
|
1.19 number of events
Standard Deviation 0.54
|
1.85 number of events
Standard Deviation 0.99
|
1.14 number of events
Standard Deviation 0.38
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
Month 6: RA related doctor visit (n=73,80,40,36)
|
1.10 number of events
Standard Deviation 0.87
|
0.86 number of events
Standard Deviation 0.76
|
0.85 number of events
Standard Deviation 0.83
|
1.00 number of events
Standard Deviation 0.96
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
Month 6: RA related ER visit (n=4,7,3,1)
|
0.00 number of events
Standard Deviation 0.00
|
0.00 number of events
Standard Deviation 0.00
|
0.00 number of events
Standard Deviation 0.00
|
0.00 number of events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
Month 6: RA related diagnostic test (n=16,16,13,7)
|
0.44 number of events
Standard Deviation 0.73
|
0.00 number of events
Standard Deviation 0.00
|
0.31 number of events
Standard Deviation 0.85
|
0.29 number of events
Standard Deviation 0.49
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
Month 6: Doctor visit (n=73,80,39,36)
|
3.26 number of events
Standard Deviation 2.83
|
3.84 number of events
Standard Deviation 4.25
|
3.64 number of events
Standard Deviation 4.03
|
4.97 number of events
Standard Deviation 6.73
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
Month 6: Hospital ER visit (n=4,7,3,1)
|
1.25 number of events
Standard Deviation 0.50
|
1.43 number of events
Standard Deviation 0.79
|
1.67 number of events
Standard Deviation 1.15
|
1.00 number of events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
Month 6: Hospitalization (n=2,1,2,1)
|
2.00 number of events
Standard Deviation 0.00
|
1.00 number of events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
1.00 number of events
Standard Deviation 0.00
|
1.00 number of events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
Month 6: RA related hospitalization (n=2,1,2,1)
|
0.00 number of events
Standard Deviation 0.00
|
0.00 number of events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
0.00 number of events
Standard Deviation 0.00
|
2.00 number of events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
Month 6:RA related outpatient surgery (n=5,2,0,2)
|
0.00 number of events
Standard Deviation 0.00
|
2.00 number of events
Standard Deviation 0.00
|
NA number of events
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
0.00 number of events
Standard Deviation 0.00
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
Month6:RA related NM practitioner visit(n=1,4,1,2)
|
1.00 number of events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
2.00 number of events
Standard Deviation 1.63
|
0.00 number of events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
1.00 number of events
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends were reported.
Outcome measures
| Measure |
CP-690,550 5 mg
n=71 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=65 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=66 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Baseline: Hospital length of stay (n=4,4,7)
|
1.75 days
Standard Deviation 0.96
|
7.00 days
Standard Deviation 7.57
|
5.43 days
Standard Deviation 3.78
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Baseline: Days of work per week (n=39,46,41)
|
4.67 days
Standard Deviation 1.24
|
4.83 days
Standard Deviation 1.29
|
4.90 days
Standard Deviation 1.18
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Baseline: Chores by housekeeper (n=20,18,24)
|
13.35 days
Standard Deviation 20.32
|
20.56 days
Standard Deviation 32.53
|
15.88 days
Standard Deviation 23.45
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Baseline: Chores by family/friend (n=71,65,66)
|
27.55 days
Standard Deviation 31.88
|
26.31 days
Standard Deviation 32.27
|
27.38 days
Standard Deviation 30.75
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Baseline: Days on sick leave (n=17,22,28)
|
19.76 days
Standard Deviation 25.59
|
13.09 days
Standard Deviation 16.15
|
23.71 days
Standard Deviation 31.28
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Baseline: Days of part time work (n=6,6,11)
|
41.33 days
Standard Deviation 40.41
|
6.83 days
Standard Deviation 4.96
|
12.36 days
Standard Deviation 16.20
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Baseline: Paid work, bothered by RA (n=36,40,32)
|
50.72 days
Standard Deviation 63.36
|
39.75 days
Standard Deviation 32.85
|
31.00 days
Standard Deviation 30.79
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Baseline: RA related devices/aids used (31,20,24)
|
2.06 days
Standard Deviation 1.59
|
1.75 days
Standard Deviation 1.48
|
1.79 days
Standard Deviation 0.88
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Month 3: Hospital length of stay (n=1,0,2)
|
12.00 days
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
NA days
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
11.00 days
Standard Deviation 12.73
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Month 3: Chores by housekeeper (n=15,14,17)
|
13.00 days
Standard Deviation 16.76
|
16.93 days
Standard Deviation 31.22
|
10.12 days
Standard Deviation 12.84
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Month 3: Chores by family/friend (n=50,41,52)
|
27.30 days
Standard Deviation 31.13
|
24.24 days
Standard Deviation 32.54
|
25.19 days
Standard Deviation 36.03
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Month 3: Days on sick leave (n=11,13,16)
|
22.09 days
Standard Deviation 28.51
|
6.62 days
Standard Deviation 4.94
|
13.69 days
Standard Deviation 20.16
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Month 3: Days of part time work (n=4,4,5)
|
8.25 days
Standard Deviation 9.46
|
9.25 days
Standard Deviation 7.89
|
8.20 days
Standard Deviation 11.12
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Month 3: RA related devices/aids used (22,11,27)
|
2.09 days
Standard Deviation 1.31
|
3.00 days
Standard Deviation 4.45
|
2.04 days
Standard Deviation 1.26
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Baseline: Days in nursing home (n=1,1,1)
|
2.00 days
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
28.00 days
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
28.00 days
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Baseline: Days devices/aids used (n=31,18,24)
|
122.94 days
Standard Deviation 139.56
|
100.28 days
Standard Deviation 122.82
|
94.63 days
Standard Deviation 86.62
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Month 3: Days in nursing home (n=1,1,1)
|
9.00 days
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
21.00 days
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
21.00 days
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Month 3: Days devices/aids used (n=21,10,26)
|
113.24 days
Standard Deviation 102.65
|
264.10 days
Standard Deviation 429.48
|
73.85 days
Standard Deviation 70.60
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Month 3: Days of work per week (n=33,47,37)
|
4.94 days
Standard Deviation 1.09
|
4.89 days
Standard Deviation 1.09
|
4.65 days
Standard Deviation 1.06
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Month 3: Paid work, bothered by RA (n=19,29,28)
|
26.58 days
Standard Deviation 30.30
|
17.76 days
Standard Deviation 23.98
|
30.54 days
Standard Deviation 30.39
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends were reported.
Outcome measures
| Measure |
CP-690,550 5 mg
n=83 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=84 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=40 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
n=36 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Number of Days as Assessed Using RA-HCRU at Month 6
Month 6: Days in nursing home (n=2,0,0,2)
|
21.50 days
Standard Deviation 0.71
|
NA days
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
NA days
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
13.50 days
Standard Deviation 2.12
|
|
Number of Days as Assessed Using RA-HCRU at Month 6
Month 6: Days devices/aids used (n=18,7,5,8)
|
141.28 days
Standard Deviation 105.31
|
68.43 days
Standard Deviation 30.12
|
182.40 days
Standard Deviation 87.11
|
75.00 days
Standard Deviation 79.33
|
|
Number of Days as Assessed Using RA-HCRU at Month 6
Month 6: Hospital length of stay (n=2,1,2,1)
|
32.00 days
Standard Deviation 33.94
|
3.00 days
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
25.00 days
Standard Deviation 21.21
|
24.00 days
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Number of Days as Assessed Using RA-HCRU at Month 6
Month 6: Days of work per week (n=34,36,20,14)
|
4.62 days
Standard Deviation 1.33
|
4.97 days
Standard Deviation 1.00
|
4.85 days
Standard Deviation 0.99
|
4.71 days
Standard Deviation 1.49
|
|
Number of Days as Assessed Using RA-HCRU at Month 6
Month 6: Chores by housekeeper (n=8,9,9,5)
|
12.75 days
Standard Deviation 13.21
|
24.89 days
Standard Deviation 36.09
|
9.22 days
Standard Deviation 10.73
|
7.80 days
Standard Deviation 4.55
|
|
Number of Days as Assessed Using RA-HCRU at Month 6
Month 6: Chores by family/friend (n=32,23,18,19)
|
28.91 days
Standard Deviation 32.10
|
18.83 days
Standard Deviation 26.97
|
19.33 days
Standard Deviation 24.14
|
17.63 days
Standard Deviation 26.46
|
|
Number of Days as Assessed Using RA-HCRU at Month 6
Month 6: Days on sick leave (n=7,10,5,5)
|
21.00 days
Standard Deviation 31.86
|
10.40 days
Standard Deviation 14.49
|
9.20 days
Standard Deviation 11.17
|
42.60 days
Standard Deviation 44.81
|
|
Number of Days as Assessed Using RA-HCRU at Month 6
Month 6: Days of part time work (n=3,3,0,3)
|
5.67 days
Standard Deviation 8.08
|
9.33 days
Standard Deviation 5.03
|
NA days
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
21.33 days
Standard Deviation 33.49
|
|
Number of Days as Assessed Using RA-HCRU at Month 6
Month 6: Paid work, bothered by RA (n=21,19,12,11)
|
25.00 days
Standard Deviation 32.76
|
14.95 days
Standard Deviation 20.85
|
22.17 days
Standard Deviation 31.98
|
19.64 days
Standard Deviation 21.73
|
|
Number of Days as Assessed Using RA-HCRU at Month 6
Month 6: RA related devices/aids used (19,8,5,8)
|
2.05 days
Standard Deviation 1.22
|
1.13 days
Standard Deviation 0.64
|
2.20 days
Standard Deviation 0.84
|
1.63 days
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.
Outcome measures
| Measure |
CP-690,550 5 mg
n=71 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=63 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=66 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Baseline: Home healthcare services (n=2,1,4)
|
5.00 hours per day
Standard Deviation 4.24
|
3.00 hours per day
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
7.25 hours per day
Standard Deviation 11.18
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Baseline: Chores by housekeeper (n=19,18,23)
|
4.68 hours per day
Standard Deviation 3.23
|
3.83 hours per day
Standard Deviation 1.54
|
4.78 hours per day
Standard Deviation 2.37
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Baseline: Chores by family/friend (n=71,63,66)
|
2.85 hours per day
Standard Deviation 1.89
|
4.44 hours per day
Standard Deviation 11.21
|
3.42 hours per day
Standard Deviation 2.61
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Baseline: Missed work due to RA (n=6,6,11)
|
2.67 hours per day
Standard Deviation 1.97
|
3.17 hours per day
Standard Deviation 2.23
|
7.55 hours per day
Standard Deviation 7.31
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Baseline: RA related home HC services (n=2,2,5)
|
1.50 hours per day
Standard Deviation 0.71
|
0.50 hours per day
Standard Deviation 0.71
|
0.80 hours per day
Standard Deviation 0.84
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Month 3: Home healthcare services (n=3,1,3)
|
4.00 hours per day
Standard Deviation 3.46
|
2.00 hours per day
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
9.33 hours per day
Standard Deviation 12.70
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Month 3: Work done (n=34,46,37)
|
7.97 hours per day
Standard Deviation 4.72
|
9.20 hours per day
Standard Deviation 8.52
|
7.76 hours per day
Standard Deviation 1.98
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Month 3: Chores by housekeeper (n=15,14,17)
|
4.00 hours per day
Standard Deviation 2.20
|
3.71 hours per day
Standard Deviation 1.14
|
5.41 hours per day
Standard Deviation 5.26
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Month 3: Chores by family/friend (n=50,41,49)
|
3.50 hours per day
Standard Deviation 3.72
|
2.83 hours per day
Standard Deviation 2.57
|
4.00 hours per day
Standard Deviation 5.34
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Month 3: Missed work due to RA (n=4,4,5)
|
3.00 hours per day
Standard Deviation 2.00
|
6.25 hours per day
Standard Deviation 6.18
|
7.80 hours per day
Standard Deviation 9.12
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Month 3: RA related home HC services (n=3,1,3)
|
1.33 hours per day
Standard Deviation 0.58
|
1.00 hours per day
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
1.67 hours per day
Standard Deviation 0.58
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Baseline: Work done (n=39,45,41)
|
9.41 hours per day
Standard Deviation 8.52
|
8.18 hours per day
Standard Deviation 7.18
|
8.98 hours per day
Standard Deviation 7.35
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.
Outcome measures
| Measure |
CP-690,550 5 mg
n=34 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=36 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=20 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
n=19 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Number of Hours Per Day as Assessed RA-HCRU at Month 6
Month 6: Home healthcare services (n=0,2,0,0)
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
2.00 hours per day
Standard Deviation 1.41
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
|
Number of Hours Per Day as Assessed RA-HCRU at Month 6
Month 6: Work done (n=34,36,20,14)
|
7.53 hours per day
Standard Deviation 2.19
|
10.36 hours per day
Standard Deviation 9.85
|
7.65 hours per day
Standard Deviation 2.16
|
10.21 hours per day
Standard Deviation 8.78
|
|
Number of Hours Per Day as Assessed RA-HCRU at Month 6
Month 6: Chores by housekeeper (n=8,9,9,5)
|
2.88 hours per day
Standard Deviation 2.36
|
3.78 hours per day
Standard Deviation 1.20
|
5.00 hours per day
Standard Deviation 3.28
|
5.00 hours per day
Standard Deviation 1.58
|
|
Number of Hours Per Day as Assessed RA-HCRU at Month 6
Month 6: Chores by family/friend (n=31,22,18,19)
|
3.16 hours per day
Standard Deviation 2.57
|
2.05 hours per day
Standard Deviation 1.05
|
2.72 hours per day
Standard Deviation 1.67
|
3.63 hours per day
Standard Deviation 5.58
|
|
Number of Hours Per Day as Assessed RA-HCRU at Month 6
Month 6: Missed work due to RA (n=3,3,0,3)
|
4.00 hours per day
Standard Deviation 0.00
|
2.67 hours per day
Standard Deviation 1.15
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
2.00 hours per day
Standard Deviation 1.73
|
|
Number of Hours Per Day as Assessed RA-HCRU at Month 6
Month 6: RA related home HC services (n=0,2,0,0)
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
1.00 hours per day
Standard Deviation 0.00
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.
Outcome measures
| Measure |
CP-690,550 5 mg
n=73 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=76 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=73 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3
Baseline (n=73,76,72)
|
4.27 units on a scale
Standard Deviation 3.20
|
4.38 units on a scale
Standard Deviation 3.12
|
4.65 units on a scale
Standard Deviation 3.23
|
—
|
|
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3
Month 3 (n=63,72,73)
|
3.52 units on a scale
Standard Deviation 3.24
|
3.51 units on a scale
Standard Deviation 4.73
|
4.04 units on a scale
Standard Deviation 3.37
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.
Outcome measures
| Measure |
CP-690,550 5 mg
n=59 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=63 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=33 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
n=29 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6
|
3.27 units on a scale
Standard Deviation 2.94
|
2.63 units on a scale
Standard Deviation 2.75
|
3.33 units on a scale
Standard Deviation 3.22
|
4.83 units on a scale
Standard Deviation 3.33
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 \[no loss\] to 100 \[complete loss of work\]).
Outcome measures
| Measure |
CP-690,550 5 mg
n=44 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=57 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=57 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
Baseline: TMS (n=42,54,48)
|
43.96 units on a scale
Standard Deviation 26.39
|
48.53 units on a scale
Standard Deviation 25.03
|
50.91 units on a scale
Standard Deviation 28.08
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
Baseline: PDS (n=43,55,55)
|
49.44 units on a scale
Standard Deviation 28.49
|
48.95 units on a scale
Standard Deviation 21.50
|
51.86 units on a scale
Standard Deviation 25.25
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
Baseline: MIDS (n=42,54,56)
|
28.44 units on a scale
Standard Deviation 24.35
|
31.79 units on a scale
Standard Deviation 23.66
|
34.36 units on a scale
Standard Deviation 27.68
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
Baseline: ODS (n=41,50,52)
|
41.95 units on a scale
Standard Deviation 31.50
|
37.30 units on a scale
Standard Deviation 25.74
|
40.20 units on a scale
Standard Deviation 25.89
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
Baseline: WLI (n=44,57,57)
|
10.51 units on a scale
Standard Deviation 6.07
|
10.27 units on a scale
Standard Deviation 5.71
|
10.99 units on a scale
Standard Deviation 5.96
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
Month 3: TMS (n=38,50,42)
|
36.09 units on a scale
Standard Deviation 26.83
|
36.47 units on a scale
Standard Deviation 26.72
|
47.62 units on a scale
Standard Deviation 29.23
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
Month 3: PDS (n=40,51,43)
|
52.08 units on a scale
Standard Deviation 30.74
|
47.20 units on a scale
Standard Deviation 26.39
|
42.31 units on a scale
Standard Deviation 24.32
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
Month 3: MIDS (n=40,54,44)
|
27.82 units on a scale
Standard Deviation 28.80
|
28.60 units on a scale
Standard Deviation 27.34
|
37.22 units on a scale
Standard Deviation 28.70
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
Month 3: ODS (n=39,51,43)
|
26.30 units on a scale
Standard Deviation 29.16
|
30.78 units on a scale
Standard Deviation 26.12
|
42.67 units on a scale
Standard Deviation 28.97
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
Month 3: WLI (n=43,56,44)
|
8.30 units on a scale
Standard Deviation 6.57
|
8.73 units on a scale
Standard Deviation 6.11
|
11.67 units on a scale
Standard Deviation 6.29
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 \[no loss\] to 100 \[complete loss of work\]).
Outcome measures
| Measure |
CP-690,550 5 mg
n=40 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=45 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=24 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
n=19 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Work Limitations Questionnaire (WLQ) Score at Month 6
Month 6: TMS (n=39,42,23,18)
|
26.96 units on a scale
Standard Deviation 29.72
|
30.77 units on a scale
Standard Deviation 27.83
|
32.50 units on a scale
Standard Deviation 30.79
|
32.73 units on a scale
Standard Deviation 25.10
|
|
Work Limitations Questionnaire (WLQ) Score at Month 6
Month 6: PDS (n=38,42,24,18)
|
47.53 units on a scale
Standard Deviation 36.97
|
44.65 units on a scale
Standard Deviation 30.60
|
40.94 units on a scale
Standard Deviation 27.82
|
47.15 units on a scale
Standard Deviation 29.47
|
|
Work Limitations Questionnaire (WLQ) Score at Month 6
Month 6: MIDS (n=40,45,24,19)
|
18.50 units on a scale
Standard Deviation 26.90
|
29.84 units on a scale
Standard Deviation 29.03
|
31.95 units on a scale
Standard Deviation 32.26
|
30.68 units on a scale
Standard Deviation 32.09
|
|
Work Limitations Questionnaire (WLQ) Score at Month 6
Month 6: ODS (n=39,44,24,19)
|
21.32 units on a scale
Standard Deviation 27.74
|
29.20 units on a scale
Standard Deviation 29.00
|
30.50 units on a scale
Standard Deviation 31.94
|
33.68 units on a scale
Standard Deviation 28.02
|
|
Work Limitations Questionnaire (WLQ) Score at Month 6
Month 6: WLI (n=40,45,24,19)
|
6.87 units on a scale
Standard Deviation 6.53
|
8.78 units on a scale
Standard Deviation 7.07
|
9.27 units on a scale
Standard Deviation 7.06
|
9.62 units on a scale
Standard Deviation 7.41
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 2, Month 1, 3Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (CRP) \<=3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.
Outcome measures
| Measure |
CP-690,550 5 mg
n=132 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=133 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=131 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3
Week 2: DAS28-3(CRP) <2.6 (n=127,125,124)
|
8 participants
|
12 participants
|
2 participants
|
—
|
|
Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3
Week 2: DAS28-3(CRP) <=3.2 (n=127,125,124)
|
19 participants
|
23 participants
|
4 participants
|
—
|
|
Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3
Month 1: DAS28-3(CRP) <2.6 (n=132,133,131)
|
14 participants
|
7 participants
|
3 participants
|
—
|
|
Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3
Month 1: DAS28-3(CRP) <=3.2 (n=132,133,131)
|
27 participants
|
42 participants
|
11 participants
|
—
|
|
Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3
Month 3: DAS28-3(CRP) <2.6 (n=132,133,131)
|
27 participants
|
35 participants
|
6 participants
|
—
|
|
Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3
Month 3: DAS28-3(CRP) <=3.2 (n=132,133,131)
|
45 participants
|
57 participants
|
13 participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 4.5, 6Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (CRP) \<=3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.
Outcome measures
| Measure |
CP-690,550 5 mg
n=132 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=133 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=66 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
n=65 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6
Month 6: DAS28-3(CRP) <2.6
|
35 participants
|
36 participants
|
11 participants
|
9 participants
|
|
Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6
Month 4.5: DAS28-3(CRP) <2.6
|
31 participants
|
42 participants
|
14 participants
|
12 participants
|
|
Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6
Month 4.5: DAS28-3(CRP) <=3.2
|
50 participants
|
57 participants
|
21 participants
|
19 participants
|
|
Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6
Month 6: DAS28-3(CRP) <=3.2
|
57 participants
|
59 participants
|
23 participants
|
19 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 3Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission.
Outcome measures
| Measure |
CP-690,550 5 mg
n=119 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=125 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=120 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3
Month 3: DAS28-4 (ESR) <=3.2
|
17 participants
|
28 participants
|
6 participants
|
—
|
|
Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3
Month 3: DAS28-4 (ESR) <2.6
|
8 participants
|
14 participants
|
2 participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission.
Outcome measures
| Measure |
CP-690,550 5 mg
n=122 Participants
CP-690,550 5 mg tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=127 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=63 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 10 mg
n=60 Participants
Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
|
|---|---|---|---|---|
|
Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6
Month 6: DAS28-4(ESR) <2.6
|
13 participants
|
20 participants
|
7 participants
|
2 participants
|
|
Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6
Month 6: DAS28-4 (ESR) <=3.2
|
35 participants
|
37 participants
|
11 participants
|
11 participants
|
Adverse Events
CP-690,550 5 mg Up to Month 3
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
CP-690,550 10 mg Up to Month 3
Serious events: 2 serious events
Other events: 43 other events
Deaths: 0 deaths
Placebo Up to Month 3
Serious events: 6 serious events
Other events: 46 other events
Deaths: 0 deaths
CP-690,550 5 mg From Month 3 to 6
Serious events: 8 serious events
Other events: 35 other events
Deaths: 0 deaths
CP-690,550 10 mg From Month 3 to 6
Serious events: 8 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CP-690,550 5 mg Up to Month 3
n=133 participants at risk
CP-690,550 5 mg tablet orally twice daily up to Month 3.
|
CP-690,550 10 mg Up to Month 3
n=134 participants at risk
CP-690,550 10 mg tablets orally twice daily up to Month 3.
|
Placebo Up to Month 3
n=132 participants at risk
Placebo matching to CP-690,550 5 mg tablet orally twice daily up to Month 3.
|
CP-690,550 5 mg From Month 3 to 6
n=199 participants at risk
CP-690,550 5 mg tablet orally twice daily from Month 3 to Month 6.
|
CP-690,550 10 mg From Month 3 to 6
n=200 participants at risk
CP-690,550 10 mg tablets orally twice daily from Month 3 to Month 6.
|
|---|---|---|---|---|---|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.00%
0/132
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.
|
0.50%
1/199
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.
|
0.00%
0/200
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.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.76%
1/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.75%
1/133
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.
|
0.00%
0/134
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.
|
0.00%
0/132
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.
|
1.0%
2/199
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.
|
0.00%
0/200
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.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.00%
0/132
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.
|
0.50%
1/199
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.
|
0.00%
0/200
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.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.76%
1/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.00%
0/132
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.
|
0.00%
0/199
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.
|
1.0%
2/200
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.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.00%
0/132
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.
|
0.00%
0/199
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.
|
0.50%
1/200
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.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/133
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.
|
0.75%
1/134
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.
|
0.00%
0/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.00%
0/132
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.
|
0.00%
0/199
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.
|
0.50%
1/200
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.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.00%
0/132
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.
|
0.50%
1/199
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.
|
0.00%
0/200
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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.00%
0/132
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.
|
0.00%
0/199
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.
|
0.50%
1/200
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.
|
|
General disorders
Drug ineffective
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.76%
1/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.00%
0/132
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.
|
0.00%
0/199
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.
|
0.50%
1/200
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.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.00%
0/132
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.
|
0.50%
1/199
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.
|
0.00%
0/200
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.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.00%
0/132
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.
|
0.00%
0/199
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.
|
0.50%
1/200
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.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.76%
1/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.00%
0/132
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.
|
0.00%
0/199
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.
|
0.50%
1/200
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.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.76%
1/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.76%
1/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.76%
1/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.76%
1/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.76%
1/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.75%
1/133
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.
|
0.00%
0/134
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.
|
0.00%
0/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Renal and urinary disorders
Goodpasture's syndrome
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.76%
1/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.00%
0/132
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.
|
0.00%
0/199
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.
|
0.50%
1/200
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.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.00%
0/132
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.
|
0.00%
0/199
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.
|
0.50%
1/200
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.00%
0/132
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.
|
0.50%
1/199
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.
|
0.00%
0/200
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.00%
0/132
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.
|
0.00%
0/199
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.
|
1.0%
2/200
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.
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.00%
0/132
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.
|
0.50%
1/199
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.
|
0.00%
0/200
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.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/133
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.
|
0.75%
1/134
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.
|
0.00%
0/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Vascular disorders
Hypertension
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.00%
0/132
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.
|
0.50%
1/199
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.
|
0.00%
0/200
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.
|
Other adverse events
| Measure |
CP-690,550 5 mg Up to Month 3
n=133 participants at risk
CP-690,550 5 mg tablet orally twice daily up to Month 3.
|
CP-690,550 10 mg Up to Month 3
n=134 participants at risk
CP-690,550 10 mg tablets orally twice daily up to Month 3.
|
Placebo Up to Month 3
n=132 participants at risk
Placebo matching to CP-690,550 5 mg tablet orally twice daily up to Month 3.
|
CP-690,550 5 mg From Month 3 to 6
n=199 participants at risk
CP-690,550 5 mg tablet orally twice daily from Month 3 to Month 6.
|
CP-690,550 10 mg From Month 3 to 6
n=200 participants at risk
CP-690,550 10 mg tablets orally twice daily from Month 3 to Month 6.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.3%
3/133
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.
|
0.75%
1/134
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.
|
0.00%
0/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Gastrointestinal disorders
Constipation
|
3.0%
4/133
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.
|
2.2%
3/134
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.
|
0.76%
1/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
8/133
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.
|
3.7%
5/134
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.
|
3.8%
5/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.00%
0/132
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.
|
2.0%
4/199
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.
|
0.00%
0/200
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.
|
|
Gastrointestinal disorders
Nausea
|
3.0%
4/133
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.
|
1.5%
2/134
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.
|
6.8%
9/132
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.
|
2.0%
4/199
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.
|
0.50%
1/200
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.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
0.00%
0/132
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.
|
3.0%
6/199
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.
|
1.5%
3/200
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.
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
5/133
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.
|
4.5%
6/134
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.
|
3.0%
4/132
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.
|
3.0%
6/199
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.
|
2.5%
5/200
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.
|
|
Infections and infestations
Sinusitis
|
0.75%
1/133
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.
|
0.75%
1/134
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.
|
3.0%
4/132
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.
|
0.50%
1/199
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.
|
2.0%
4/200
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
5/133
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.
|
1.5%
2/134
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.
|
3.0%
4/132
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.
|
2.5%
5/199
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.
|
4.0%
8/200
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.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
5/133
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.
|
2.2%
3/134
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.
|
2.3%
3/132
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.
|
2.0%
4/199
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.
|
1.0%
2/200
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.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/133
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.
|
0.00%
0/134
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.
|
2.3%
3/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.3%
3/133
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.
|
0.00%
0/134
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.
|
3.8%
5/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.75%
1/133
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.
|
2.2%
3/134
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.
|
0.00%
0/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Vascular disorders
Hypertension
|
0.75%
1/133
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.
|
2.2%
3/134
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.
|
0.76%
1/132
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.
|
2.0%
4/199
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.
|
1.0%
2/200
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.
|
|
General disorders
Fatigue
|
0.75%
1/133
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.
|
2.2%
3/134
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.
|
0.00%
0/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
General disorders
Oedema peripheral
|
2.3%
3/133
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.
|
0.75%
1/134
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.
|
3.8%
5/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/133
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.
|
2.2%
3/134
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.
|
0.00%
0/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/133
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.
|
2.2%
3/134
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.
|
0.00%
0/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.75%
1/133
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.
|
0.75%
1/134
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.
|
3.8%
5/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
2/133
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.
|
2.2%
3/134
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.
|
1.5%
2/132
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.
|
1.0%
2/199
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.
|
2.0%
4/200
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.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/133
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.
|
0.75%
1/134
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.
|
2.3%
3/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
2.3%
3/133
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.
|
0.75%
1/134
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.
|
3.0%
4/132
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.
|
3.5%
7/199
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.
|
0.00%
0/200
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.
|
|
Nervous system disorders
Headache
|
2.3%
3/133
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.
|
6.0%
8/134
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.
|
0.76%
1/132
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.
|
0.50%
1/199
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.
|
2.0%
4/200
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.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/133
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.
|
0.75%
1/134
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.
|
2.3%
3/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
|
Psychiatric disorders
Depression
|
1.5%
2/133
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.
|
3.0%
4/134
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.
|
0.76%
1/132
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.
|
0.00%
0/199
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.
|
0.00%
0/200
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER