Phase 3
Completed N=399
Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT00960440 ↗
Enrolled (actual)
399
Serious AEs
3.3%
Results posted
Jan 2013
Primary outcomePrimary: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 — 41.67; 48.12; 24.43 percentage of participants — p=<0.0001
Summary
This study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 |
41.67; 48.12; 24.43 | <0.0001 sig |
| PRIMARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 |
1.60; 1.50; 1.63; -0.41; -0.41; -0.17 | <0.0001 sig |
| PRIMARY 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; 11.20; 1.67 | 0.0017 sig |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1 |
27.69; 32.81; 16.67; 42.42; 44.36; 27.48 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4.5 and 6 |
54.55; 47.37; 50.00; 46.15; 51.52; 54.89 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3 |
7.69; 5.47; 1.59; 12.88; 17.29; 6.11 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4.5 and 6 |
28.79; 28.57; 30.30; 20.00; 37.12; 30.08 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3 |
2.31; 2.34; 0.00; 7.58; 6.77; 0.00 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4.5 and 6 |
10.61; 12.78; 12.12; 7.69; 15.91; 15.79 | — |
| SECONDARY 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 |
5.38; 5.31; 5.39; 4.46; 4.13; 5.10 | — |
| SECONDARY Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6 |
3.43; 3.30; 3.57; 3.69; 3.36; 3.07 | — |
| SECONDARY Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3 |
6.48; 6.40; 6.47; 4.58; 4.26; 5.56 | — |
| SECONDARY Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6 |
3.99; 3.70; 4.07; 4.39 | — |
| SECONDARY Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3 |
1.38; 1.28; 1.49; 1.37; 1.19; 1.38 | — |
| SECONDARY Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6 |
1.19; 1.10; 1.08; 1.26; 1.10; 1.02 | — |
| SECONDARY Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3 |
65.73; 60.10; 60.74; 49.79; 42.35; 55.88 | — |
| SECONDARY Patient Assessment of Arthritis Pain at Month 4.5 and 6 |
38.93; 35.01; 33.11; 40.62; 34.38; 29.56 | — |
| SECONDARY Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3 |
64.69; 58.79; 61.87; 48.24; 41.75; 57.70 | — |
| SECONDARY Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6 |
37.40; 36.01; 34.38; 38.79; 34.59; 31.25 | — |
| SECONDARY Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3 |
65.38; 58.68; 64.36; 46.51; 41.29; 51.36 | — |
| SECONDARY Physician Global Assessment of Arthritis at Month 4.5 and 6 |
27.50; 26.12; 28.67; 28.17; 24.17; 19.65 | — |
| SECONDARY 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 |
30.54; 31.61; 28.32; 33.66; 34.08; 32.53 | — |
| SECONDARY 36-Item Short-Form Health Survey (SF-36) at Month 6 |
35.62; 38.47; 35.00; 33.97; 40.72; 43.51 | — |
| SECONDARY Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 |
40.55; 39.87; 44.65; 43.10; 41.57; 46.08 | — |
| SECONDARY Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 |
35.32; 32.03; 38.78; 35.35; 35.75; 32.92 | — |
| SECONDARY Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3 |
53; 59; 48; 52; 62; 50 | — |
| SECONDARY Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 |
50; 57; 21; 24 | — |
| SECONDARY Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3 |
27.84; 29.48; 26.98; 33.30; 33.66; 27.93 | — |
| SECONDARY Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6 |
34.69; 35.98; 33.57; 31.63 | — |
| SECONDARY Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3 |
0.38; 0.47; 0.38; 0.56; 0.63; 0.49 | — |
| SECONDARY Euro Quality of Life - 5 Dimensions (EQ-5D) - Health State Profile Utility Score at Month 6 |
0.62; 0.68; 0.60; 0.55 | — |
| SECONDARY Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 |
1.11; 1.09; 1.15; 1.89; 1.96; 1.93 | — |
| SECONDARY Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 |
1.29; 1.22; 1.20; 1.27; 1.96; 1.93 | — |
| SECONDARY Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 |
5.07; 5.09; 4.58; 5.75; 4.83; 21.40 | — |
| SECONDARY Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 |
3.26; 3.84; 3.64; 4.97; 5.00; 15.50 | — |
| SECONDARY Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 |
1.75; 7.00; 5.43; 2.00; 28.00; 28.00 | — |
| SECONDARY Number of Days as Assessed Using RA-HCRU at Month 6 |
32.00; 3.00; 25.00; 24.00; 21.50; NA | — |
| SECONDARY Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 |
5.00; 3.00; 7.25; 9.41; 8.18; 8.98 | — |
| SECONDARY Number of Hours Per Day as Assessed RA-HCRU at Month 6 |
NA; 2.00; NA; NA; 7.53; 10.36 | — |
| SECONDARY Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3 |
4.27; 4.38; 4.65; 3.52; 3.51; 4.04 | — |
| SECONDARY Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6 |
3.27; 2.63; 3.33; 4.83 | — |
| SECONDARY Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 |
43.96; 48.53; 50.91; 49.44; 48.95; 51.86 | — |
| SECONDARY Work Limitations Questionnaire (WLQ) Score at Month 6 |
26.96; 30.77; 32.50; 32.73; 47.53; 44.65 | — |
Eligibility Criteria
Inclusion Criteria
- Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate who have inadequate response to Tumor Necrosis Factor (TNF) inhibitors.
Exclusion Criteria
- Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.
Data sourced from ClinicalTrials.gov (NCT00960440). 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.