Phase 3
Completed N=717
A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00853385 ↗Enrolled (actual)
717
Serious AEs
3.8%
Results posted
Jan 2013
Primary outcomePrimary: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 — 51.53; 52.55; 28.30; 47.24 percentage of participants — p=<0.0001
Summary
This is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background methotrexate in patients with Rheumatoid Arthritis. The 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 on background methotrexate 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 Rheumatoid Arthritis. An active comparator, adalimumab, is also included.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 |
51.53; 52.55; 28.30; 47.24 | <0.0001 sig |
| PRIMARY Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3 |
1.50; 1.53; 1.42; 1.50; -0.49; -0.59 | <0.0001 sig |
| PRIMARY Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6 |
6.21; 12.50; 1.09; 6.74 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3 |
41.24; 45.92; 16.04; 37.88; 60.71; 58.67 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12 |
49.49; 50.51; 30.36; 36.00; 47.24; 49.49 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6 |
14.95; 16.33; 4.72; 12.12; 34.18; 27.55 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12 |
35.71; 37.24; 17.86; 26.00; 29.15; 36.73 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6 |
2.58; 4.08; 0.94; 3.03; 12.24; 14.80 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12 |
18.37; 21.94; 8.93; 10.00; 11.06; 22.96 | — |
| SECONDARY Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 |
5.43; 5.43; 5.44; 5.33; 4.26; 4.21 | — |
| SECONDARY Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12 |
3.13; 3.20; 3.11; 3.03; 3.46; 3.05 | — |
| SECONDARY Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 |
6.56; 6.48; 6.45; 6.36; 5.23; 5.14 | — |
| SECONDARY Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12 |
4.00; 4.08; 3.99; 3.93; 4.20; 3.85 | — |
| 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 Month 1, 3 and 6 |
1.15; 1.11; 1.32; 1.12; 1.00; 0.94 | — |
| SECONDARY Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12 |
0.86; 0.85; 0.89; 0.90; 0.97; 0.83 | — |
| SECONDARY Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 |
59.29; 59.01; 55.20; 56.46; 39.71; 36.77 | — |
| SECONDARY Patient Assessment of Arthritis Pain at Month 9 and 12 |
27.04; 27.99; 31.31; 24.93; 32.70; 26.99 | — |
| SECONDARY Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 |
59.86; 56.55; 54.46; 57.22; 41.85; 36.61 | — |
| SECONDARY Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12 |
28.39; 29.47; 31.78; 30.00; 34.38; 26.86 | — |
| SECONDARY Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 |
59.92; 59.56; 60.28; 58.64; 38.90; 36.16 | — |
| SECONDARY Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12 |
19.93; 21.92; 25.82; 23.78; 25.45; 18.67 | — |
| SECONDARY 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 |
32.02; 31.06; 32.23; 31.74; 34.00; 33.54 | — |
| SECONDARY 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 |
39.77; 38.74; 38.94; 38.59; 38.75; 41.66 | — |
| SECONDARY Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6 |
28.18; 28.56; 30.49; 27.95; 32.54; 33.95 | — |
| SECONDARY Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12 |
35.76; 37.53; 36.71; 35.71; 34.30 | — |
| SECONDARY Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 |
42.13; 40.20; 39.14; 40.90; 43.24; 42.27 | — |
| SECONDARY Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 |
34.62; 30.64; 34.69; 34.68; 35.72; 34.86 | — |
| SECONDARY Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 |
94; 94; 49; 88; 93; 107 | — |
| SECONDARY Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 |
80; 84; 28; 19; 75 | — |
| SECONDARY Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6 |
0.43; 0.43; 0.50; 0.45; 0.61; 0.60 | — |
| SECONDARY Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12 |
0.69; 0.69; 0.68; 0.66; 0.66 | — |
| SECONDARY Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 |
41.46; 42.09; 37.65; 46.43; 49.99; 52.14 | — |
| SECONDARY Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 |
25.59; 20.77; 32.69; 28.75; 26.57; 54.35 | — |
| SECONDARY Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 |
1.16; 1.13; 1.15; 1.15; 1.95; 1.93 | — |
| SECONDARY Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 |
1.31; 1.27; 1.24; 1.24; 1.23; 1.98 | — |
| SECONDARY Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 |
4.26; 4.06; 4.50; 3.87; 1.33; 3.00 | — |
| SECONDARY Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 |
2.73; 2.80; 3.92; 3.50; 2.94; 10.67 | — |
| SECONDARY Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 |
13.64; 10.83; 13.43; 12.82; 19.33; NA | — |
| SECONDARY Number of Days as Assessed Using RA-HCRU at Month 12 |
8.00; 5.60; 15.00; 1.00; 15.33; 24.50 | — |
| SECONDARY Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 |
3.00; 1.50; 2.00; 1.00; 7.76; 7.54 | — |
| SECONDARY Number of Hours Per Day as Assessed RA-HCRU at Month 12 |
NA; NA; NA; NA; 1.00; 7.52 | — |
| SECONDARY Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 |
4.16; 4.16; 4.08; 4.19; 2.68; 2.81 | — |
| SECONDARY Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12 |
2.18; 1.92; 2.69; 2.23; 1.93 | — |
Eligibility Criteria
Inclusion Criteria
- The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
- The patient must have had an inadequate response to methotrexate and have active disease, 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.
- No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
- The patient must have been on a stable dose of 7.5 mg to 25 mg weekly of methotrexate and washed out of all other DMARDs.
Exclusion Criteria
- Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2. White blood cell count <3,000 cu.mm. Absolute neutrophil count <1,200 cu.mm; 4. Platelet count <100,000/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
- Patients who have failed any TNFi for either lack of efficacy or a TNFi mechanism related adverse event.
- Patients who have previously received adalimumab therapy for any reason.
- Patients who are contraindicated for treatment with adalimumab in accordance with the approved local label.
- Patients meeting the New York Heart Association Class III and Class IV Congestive Heart failure
Data sourced from ClinicalTrials.gov (NCT00853385). 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.