Phase 3 Completed N=800 Randomized Quadruple-blind Treatment

A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

Arthritis, Rheumatoid

Source: ClinicalTrials.gov NCT00847613 ↗

Enrolled (actual)

800

Serious AEs

3.6%

Results posted

Jan 2013

Primary outcomePrimary: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 — 51.46; 61.81; 25.32 percentage of participants — p=<0.0001

Summary

This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6	51.46; 61.81; 25.32	<0.0001 sig
PRIMARY Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6	28.66; 34.66; 29.53; 0.12; 0.06; 0.47	0.0376 sig
PRIMARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3	1.41; 1.39; 1.31; -0.3; -0.4; -0.1	<0.0001 sig
PRIMARY Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6	7.17; 15.95; 1.55	<0.0001 sig
SECONDARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 1 and 3	41.42; 52.10; 16.34; 56.31; 66.34; 27.27	—
SECONDARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24	47.90; 62.46; 32.91; 29.33; 48.54; 56.96	—
SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6	16.83; 18.45; 1.31; 28.80; 36.25; 7.79	—
SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24	32.69; 44.01; 22.78; 20.00; 32.69; 41.10	—
SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6	3.88; 3.56; 0.00; 10.68; 17.15; 2.60	—
SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9, 12, 15, 18, 21 and 24	18.45; 28.48; 8.86; 12.00; 18.77; 27.51	—
SECONDARY Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6	5.22; 5.20; 5.16; 4.04; 3.84; 4.73	—
SECONDARY Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9, 12, 15, 18, 21 and 24	3.11; 2.88; 2.99; 3.03; 3.07; 2.75	—
SECONDARY Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6	6.34; 6.25; 6.27; 5.12; 4.84; 5.83	—
SECONDARY Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9, 12, 15, 18, 21 and 24	4.12; 3.84; 4.04; 3.87; 4.09; 3.79	—
SECONDARY Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])	—	—
SECONDARY Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])	—	—
SECONDARY Modified Total Sharp Scores (mTSS) at Baseline	31.1; 37.3; 32.6	—
SECONDARY Modified Total Sharp Scores (mTSS) at Month 12 and 24	31.4; 37.3; 36.1; 30.9	—
SECONDARY Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6	1.41; 1.39; 1.31; 1.16; 1.02; 1.25	—
SECONDARY Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9, 12, 15, 18, 21 and 24	0.91; 0.75; 0.95; 0.74; 0.90; 0.76	—
SECONDARY Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6	58.39; 57.62; 55.01; 41.61; 33.91; 49.22	—
SECONDARY Patient Assessment of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24	31.59; 27.14; 31.74; 27.54; 30.54; 27.45	—
SECONDARY Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6	58.06; 56.45; 54.11; 41.26; 34.95; 48.30	—
SECONDARY Patient Global Assessment (PtGA) of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24	31.19; 28.05; 31.46; 27.41; 31.77; 29.12	—
SECONDARY Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6	59.44; 58.42; 55.90; 37.97; 35.19; 45.50	—
SECONDARY Physician Global Assessment (PGA) of Arthritis at Month 9, 12, 15, 18, 21 and 24	21.68; 18.90; 19.92; 19.29; 20.40; 17.97	—
SECONDARY 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6	32.16; 32.61; 33.50; 34.61; 35.41; 36.69	—
SECONDARY 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24	37.94; 40.66; 38.31; 41.29; 41.41; 43.96	—
SECONDARY Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6	40.19; 39.70; 37.30; 38.65; 38.47; 36.39	—
SECONDARY Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6	140; 132; 70; 144; 156; 67	—
SECONDARY Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24	32.50; 32.68; 30.92; 28.34; 31.69; 31.97	—
SECONDARY Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24	131; 134; 36; 28	—
SECONDARY Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6	28.59; 29.49; 31.07; 33.13; 34.31; 31.52	—
SECONDARY Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12, 18 and 24	35.06; 35.88; 35.58; 37.29	—
SECONDARY Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6	0.43; 0.47; 0.47; 0.60; 0.67; 0.52	—
SECONDARY Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12, 18 and 24	0.64; 0.69; 0.63; 0.74	—
SECONDARY Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6	49.74; 41.93; 44.02; 50.17; 50.11; 49.96	—
SECONDARY Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24	35.82; 31.30; 43.69; 37.58; 45.64; 46.16	—
SECONDARY Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6	1.14; 1.15; 1.16; 1.93; 1.96; 1.94	—
SECONDARY Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24	1.21; 1.18; 1.16; 1.17; 1.93; 1.96	—
SECONDARY Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6	3.78; 4.00; 4.80; 1.16; 1.20; 1.25	—
SECONDARY Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24	2.70; 2.43; 3.27; 2.81; 0.92; 0.89	—
SECONDARY Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6	10.94; 20.22; 22.20; 14.33; 17.67; 15.50	—
SECONDARY Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24	10.13; 7.00; 2.50; 3.00; 11.50; NA	—
SECONDARY Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6	1.50; 3.00; 1.33; 1.00; 1.50; 0.67	—
SECONDARY Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24	20.50; 4.00; NA; NA; 0.50; 3.00	—
SECONDARY Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6	5.29; 4.88; 4.68; 3.81; 3.11; 4.40	—
SECONDARY Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12, 18 and 24	3.19; 2.66; 2.51; 2.66	—

Eligibility Criteria

Inclusion Criteria

Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate

Exclusion Criteria

Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00847613). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.