Phase 3
Completed N=795
A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT00856544 ↗
Enrolled (actual)
795
Serious AEs
2.2%
Results posted
Jan 2013
Primary outcomePrimary: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 — 52.73; 58.25; 31.21 percentage of participants — p=<0.0001
Summary
This Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg BID is safe and effective when used in combination with a variety of traditional disease modifying antirheumatic drugs in adult patients with rheumatoid arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 rheumatoid arthritis studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 |
52.73; 58.25; 31.21 | <0.0001 sig |
| PRIMARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 |
1.44; 1.43; 1.35; -0.45; -0.54; -0.16 | <0.0001 sig |
| PRIMARY Percentage of Participants Achieving Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])Less Than 2.6 at Month 6 |
9.13; 13.33; 2.70 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6 |
27.33; 32.25; 10.90; 38.59; 48.54; 22.93 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12 |
50.48; 62.14; 37.97; 34.62; 51.45; 56.63 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6 |
5.79; 8.14; 1.28; 11.58; 18.12; 1.27 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12 |
31.51; 43.04; 25.32; 26.92; 33.44; 42.72 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6 |
0.32; 2.28; 0.00; 3.54; 7.12; 0.00 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12 |
14.15; 25.24; 10.13; 11.54; 19.29; 25.57 | — |
| SECONDARY Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 |
5.21; 5.26; 5.22; 4.41; 4.18; 4.92 | — |
| SECONDARY Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12 |
3.21; 2.88; 3.22; 2.83; 3.08; 2.81 | — |
| SECONDARY Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6 |
6.29; 6.36; 6.30; 4.41; 4.20; 5.32 | — |
| SECONDARY Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 12 |
3.82; 3.50; 3.76; 3.62 | — |
| 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 Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 |
1.44; 1.43; 1.35; 1.24; 1.14; 1.28 | — |
| SECONDARY Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12 |
0.89; 0.71; 0.85; 0.70; 0.86; 0.73 | — |
| SECONDARY Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 |
57.08; 58.58; 57.11; 46.81; 41.85; 51.01 | — |
| SECONDARY Patient Assessment of Arthritis Pain at Month 9 and 12 |
30.78; 27.13; 29.50; 25.26; 30.18; 25.43 | — |
| SECONDARY Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 |
59.03; 60.22; 57.92; 46.59; 42.99; 51.27 | — |
| SECONDARY Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12 |
32.06; 28.01; 28.97; 28.56; 30.64; 27.94 | — |
| SECONDARY Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 |
60.48; 59.66; 58.87; 46.41; 43.79; 49.08 | — |
| SECONDARY Physician Global Assessment (PGA) of Arthritis at Month 9 and 12 |
24.36; 20.09; 22.70; 20.63; 21.52; 18.12 | — |
| SECONDARY 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 |
32.53; 31.74; 32.76; 33.73; 33.15; 33.91 | — |
| SECONDARY 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 |
39.40; 40.67; 38.86; 40.83; 40.21; 42.03 | — |
| SECONDARY Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 |
41.05; 40.89; 39.75; 39.51; 40.08; 37.87 | — |
| SECONDARY Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 |
139; 139; 70; 155; 145; 72 | — |
| SECONDARY Medical Outcome Study (MOS) Sleep Scale at Month 12 |
34.17; 32.24; 31.74; 33.58; 33.71; 32.58 | — |
| SECONDARY Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12 |
134; 144; 37; 36 | — |
| SECONDARY Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 |
29.01; 28.65; 29.72; 33.16; 33.94; 31.78 | — |
| SECONDARY Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12 |
35.02; 36.34; 36.93; 36.07 | — |
| SECONDARY Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6 |
0.46; 0.48; 0.51; 0.63; 0.68; 0.56 | — |
| SECONDARY Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12 |
0.68; 0.70; 0.66; 0.69 | — |
| SECONDARY Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 |
47.13; 46.05; 39.98; 48.08; 50.83; 51.88 | — |
| SECONDARY Work Limitations Questionnaire (WLQ) Score at Month 12 |
37.01; 35.29; 30.82; 36.57; 44.15; 42.41 | — |
| SECONDARY Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 |
1.13; 1.11; 1.16; 1.94; 1.94; 1.95 | — |
| SECONDARY Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 |
1.48; 1.44; 1.40; 1.50; 1.95; 1.95 | — |
| SECONDARY Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 |
4.27; 4.17; 4.13; 1.33; 1.32; 1.25 | — |
| SECONDARY Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 |
3.17; 2.58; 3.19; 2.62; 0.89; 0.74 | — |
| SECONDARY Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 |
12.69; 15.26; 14.50; 28.00; 14.50; 21.00 | — |
| SECONDARY Number of Days as Assessed Using RA-HCRU at Month 12 |
8.88; 12.38; 2.00; 1.50; 19.50; NA | — |
| SECONDARY Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 |
4.67; 2.75; 1.50; 0.67; 1.00; 0.50 | — |
| SECONDARY Number of Hours Per Day as Assessed RA-HCRU at Month 12 |
1.00; 2.00; 1.00; NA; 0.00; 2.00 | — |
| SECONDARY Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 |
5.03; 4.72; 4.55; 3.74; 3.18; 3.97 | — |
| SECONDARY Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12 |
2.79; 2.52; 2.84; 3.08 | — |
Eligibility Criteria
Inclusion Criteria
- The patient has a diagnosis of Rheumatoid Arthritis based on the American College of Rheumatology (ACR) 1987 Revised Criteria.
- The patient has active disease as defined by both >=4 tender or painful joints on motion and >= 4 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL.
- Patient had an inadequate response to at least one disease modifying antirheumatic drug (traditional or biologic) due to lack of efficacy or toxicity.
- Patient must remain on at least one background traditional disease modifying antirheumatic drug.
- No evidence of inadequately treated latent or active infection with Mycobacterium tuberculosis.
Exclusion Criteria
- Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L.
- History of any other rheumatic autoimmune disease other than Sjogren's syndrome.
- No malignancy or history of malignancy.
- History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug.
Data sourced from ClinicalTrials.gov (NCT00856544). 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.