Phase 2
Completed N=109
Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)
Source: ClinicalTrials.gov NCT01164579 ↗Enrolled (actual)
109
Serious AEs
4.6%
Results posted
Apr 2015
Primary outcomePrimary: Change From Baseline to Month 3 in Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) Wrist and Metacarpophalangeal (MCP) Synovitis — -0.80; -0.69; -0.17 score on a scale — p=0.2696
Summary
Evaluation of efficacy and safety of tofacitinib (CP-690,550) for the treatment of early rheumatoid arthritis in adult patients with moderate to severe disease who are methotrexate naïve. The efficacy will be evaluated by exploring the effects on joint structure assessed by magnetic resonance imaging, x-rays and by standard clinical assessment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Month 3 in Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) Wrist and Metacarpophalangeal (MCP) Synovitis |
-0.80; -0.69; -0.17 | 0.2696 |
| PRIMARY Change From Baseline to Month 6 in OMERACT RAMRIS Wrist and MCP Bone Marrow Edema |
-1.26; -1.45; 0.29 | 0.0089 sig |
| SECONDARY Change From Baseline to Months 1, 6, and 12 in OMERACT RAMRIS Wrist and MCP Synovitis |
-0.42; -0.34; -0.17; -1.22; -1.29; -0.28 | 0.6576 |
| SECONDARY Change From Baseline to Months 1, 3, and 12 in OMERACT RAMRIS Bone Marrow Edema in Wrist and MCP |
-0.29; 0.19; 0.11; -0.77; -0.86; 0.47 | 0.4890 |
| SECONDARY Change From Baseline to Months 1, 3, 6, and 12 in OMERACT RAMRIS Wrist and MCP Erosions |
-0.12; 0.27; 0.27; -0.12; 0.36; 0.44 | 0.2689 |
| SECONDARY Modified Total Sharp Score (mTSS) at Months 6 and 12 |
11.28; 10.70; 11.77; 11.70; 10.69; 12.21 | 0.5019 |
| SECONDARY Change From Baseline to Months 6 and 12 in mTSS |
0.44; -0.14; 0.93; 0.85; -0.15; 1.36 | 0.5019 |
| SECONDARY Joint Space Narrowing (JSN) Scores at Months 6 and 12 |
5.45; 5.11; 5.52; 5.59; 5.05; 5.88 | 0.8959 |
| SECONDARY Change From Baseline to Months 6 and 12 in JSN Scores |
0.29; -0.06; 0.35; 0.43; -0.12; 0.71 | 0.8959 |
| SECONDARY Erosion Scores at Months 6 and 12 |
5.84; 5.59; 6.26; 6.10; 5.64; 6.33 | 0.2351 |
| SECONDARY Change From Baseline to Months 6 and 12 in Erosion Score |
0.16; -0.10; 0.58; 0.42; -0.05; 0.65 | 0.2351 |
| SECONDARY Percentage of Participants With an American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20) Response |
42.86; 57.14; 29.73; 68.57; 61.11; 40.54 | 0.2430 |
| SECONDARY Percentage of Participants With an ACR 50% Improvement (ACR50) Response |
22.86; 22.86; 2.70; 45.71; 33.33; 16.22 | 0.0078 sig |
| SECONDARY Percentage of Participants With an ACR 70% Improvement (ACR70) Response |
8.57; 2.86; 0.00; 31.43; 22.22; 5.41 | 0.0700 |
| SECONDARY Disease Activity Score Based on 28-Joint Count and CRP (DAS28-3 [CRP]) |
5.14; 5.48; 5.36; 3.71; 4.03; 4.65 | — |
| SECONDARY Change From Baseline in DAS28-3 (CRP) |
-1.61; -1.40; -0.73; -2.32; -1.88; -1.24 | 0.0010 sig |
| SECONDARY Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) |
6.25; 6.50; 6.44; 4.60; 4.93; 5.51 | — |
| SECONDARY Change From Baseline in DAS28-4 (ESR) |
-1.77; -1.57; -0.94; -2.59; -2.08; -1.41 | 0.0046 sig |
| SECONDARY Percentage of Participants With DAS28-3 (CRP) Response (Good or Moderate Improvement) |
75.76; 71.43; 43.24; 91.18; 80.56; 56.76 | 0.0032 sig |
| SECONDARY Percentage of Participants With DAS28-3 (CRP) Score ≤3.2 |
33.33; 17.14; 10.81; 50.00; 36.11; 21.62 | 0.0197 sig |
| SECONDARY Percentage of Participants With DAS28-3 (CRP) Score <2.6 |
18.18; 5.71; 5.41; 35.29; 16.67; 8.11 | 0.0959 |
| SECONDARY Percentage of Participants With DAS28-4 (ESR) Response (Good or Moderate Improvement) |
67.65; 62.86; 29.73; 85.29; 69.44; 59.46 | 0.0005 sig |
| SECONDARY Percentage of Participants With DAS28-4 (ESR) ≤3.2 |
20.59; 8.57; 2.70; 35.29; 13.89; 8.11 | 0.0160 sig |
| SECONDARY Percentage of Participants With DAS28-4 (ESR) <2.6 |
5.88; 2.86; 0.00; 17.65; 5.56; 2.70 | 0.1449 |
Eligibility Criteria
Inclusion Criteria
- Adult patients with moderate to severe early rheumatoid arthritis (< 2 years) who are methotrexate and biologic disease modifying antirheumatic drug naive.
Exclusion Criteria
- Pregnant or lactating patients;
- Patients with renal or hepatic impairment or other severe or progressing disease;
- Patients with contraindication to magnetic resonance imaging with gadolinium contrast.
Data sourced from ClinicalTrials.gov (NCT01164579). 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.