Phase 3
Completed N=611
A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT00814307 ↗
Enrolled (actual)
611
Serious AEs
2.0%
Results posted
Jan 2013
Primary outcomePrimary: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 — 59.75; 65.70; 26.67 percentage of participants — p=<0.0001
Summary
This Phase 3 study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day as monotherapy in adult patients with moderate to severe 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 3 |
59.75; 65.70; 26.67 | <0.0001 sig |
| PRIMARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 |
1.53; 1.50; 1.53; -0.48; -0.54; -0.18 | <.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 3 |
6.11; 10.05; 4.81 | 0.0728 |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2 |
29.58; 39.17; 11.76; 46.47; 52.07; 21.67 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6 |
69.29; 69.01; 51.67; 61.67; 68.46; 69.83 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3 |
5.83; 12.92; 4.20; 17.43; 23.97; 4.17 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6 |
37.34; 42.98; 28.33; 28.33; 39.42; 45.45 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3 |
2.08; 4.58; 0.00; 4.98; 9.09; 1.67 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6 |
19.92; 26.03; 13.33; 15.00; 21.16; 28.51 | — |
| SECONDARY Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3 |
6.71; 6.70; 6.65; 4.78; 4.55; 5.54 | — |
| SECONDARY Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6 |
4.33; 4.01; 4.31; 3.98 | — |
| SECONDARY Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3 |
5.68; 5.60; 5.56; 4.79; 4.42; 5.30 | — |
| SECONDARY Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6 |
3.65; 3.26; 3.89; 3.50; 3.54; 3.12 | — |
| SECONDARY Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3 |
1.53; 1.50; 1.53; 1.27; 1.21; 1.43 | — |
| SECONDARY Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6 |
0.97; 0.88; 1.08; 1.09; 0.95; 0.87 | — |
| SECONDARY Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 |
61.35; 62.03; 61.79; 45.92; 42.13; 55.61 | — |
| SECONDARY Patient Assessment of Arthritis Pain at Month 4, 5 and 6 |
33.18; 29.70; 34.27; 35.47; 32.63; 29.10 | — |
| SECONDARY Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 |
61.66; 63.46; 62.63; 46.34; 41.32; 55.95 | — |
| SECONDARY Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6 |
33.59; 29.69; 35.27; 36.45; 34.59; 29.37 | — |
| SECONDARY Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 |
61.46; 60.84; 62.22; 43.43; 40.47; 52.15 | — |
| SECONDARY Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6 |
25.30; 21.21; 27.48; 25.86; 23.60; 20.99 | — |
| SECONDARY 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 |
30.09; 30.51; 31.41; 32.84; 33.45; 33.33 | — |
| SECONDARY 36-Item Short-Form Health Survey (SF-36) at Month 6 |
36.99; 38.43; 35.74; 35.26; 39.85; 40.93 | — |
| SECONDARY Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 |
42.45; 43.09; 47.32; 40.59; 42.38; 45.98 | — |
| SECONDARY Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Month 3 |
96; 98; 45; 113; 117; 52 | — |
| SECONDARY Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 |
35.68; 33.33; 37.29; 35.64; 35.17; 33.33 | — |
| SECONDARY Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 |
105; 107; 23; 25 | — |
| SECONDARY Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3 |
27.90; 27.72; 27.17; 34.40; 35.42; 30.06 | — |
| SECONDARY Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6 |
34.58; 36.30; 33.63; 36.46 | — |
| SECONDARY Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline and Month 3 |
0.41; 0.39; 0.42; 0.60; 0.66; 0.51 | — |
| SECONDARY Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 6 |
0.63; 0.68; 0.58; 0.65 | — |
| SECONDARY Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 |
1.19; 1.15; 1.17; 1.94; 1.92; 1.92 | — |
| SECONDARY Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 |
1.30; 1.30; 1.28; 1.28; 1.93; 1.94 | — |
| SECONDARY Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 |
4.38; 3.85; 3.56; 1.26; 1.18; 1.33 | — |
| SECONDARY Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 |
3.22; 3.69; 3.00; 3.69; 0.92; 0.83 | — |
| SECONDARY Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 |
15.43; 9.63; 4.29; 23.25; 16.50; 10.00 | — |
| SECONDARY Number of Days as Assessed Using RA-HCRU at Month 6 |
13.60; 7.67; 13.50; 1.50; 24.00; 15.00 | — |
| SECONDARY Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 |
2.00; 3.75; 1.00; 1.50; 2.25; 1.00 | — |
| SECONDARY Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 |
4.00; 1.00; 0.00; 1.00; 1.00; 1.00 | — |
| SECONDARY Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3 |
5.59; 5.61; 5.41; 3.39; 3.43; 4.57 | — |
| SECONDARY Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6 |
3.22; 3.18; 3.21; 3.94 | — |
| SECONDARY Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 |
50.84; 48.98; 48.74; 51.84; 49.24; 51.21 | — |
| SECONDARY Work Limitations Questionnaire (WLQ) Score at Month 6 |
36.27; 30.42; 34.40; 39.86; 45.37; 45.17 | — |
Eligibility Criteria
Inclusion Criteria
- The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
- The patient has active disease at both Screening and Baseline, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) >28 mm in the local laboratory. 2. CRP >7 mg/L in the central laboratory
- Patient had an inadequate response to at least one DMARD (traditional or biologic) due to lack of efficacy or toxicity.
- No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
- Patient has washed out of all DMARDs other that antimalarials
Exclusion Criteria
- Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2. White blood cell count <3.0 x 109/L; 3. Absolute neutrophil count <1.2 x 109/L; 4. Platelet count <100 x 109/L
- History of any other autoimmune rheumatic 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 (NCT00814307). 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.