| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01164579 | Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA) | PHASE2 | COMPLETED | 109 | — | — | Oct 1, 2010 | Nov 1, 2013 | Apr 22, 2015 | 40 | United States, Argentina +7 |
Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the first through fifth MCP joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 24. A negative value in synovitis change from Baseline score indicates an improvement.
Bone edema was assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Bone edema was defined as a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone was scored separately; the scale was 0-3 based on the proportion of bone with edema, as follows 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. OMERACT RAMRIS total bone edema score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist was 75 (range 0-75). Increasing score=greater severity.
| Arm | Type | Description |
|---|---|---|
| Tofacitinib (CP 690,550) 10 mg BID plus MTX | EXPERIMENTAL | - |
| Tofacitinib (CP-690,550) 10 mg BID, tablet plus placebo MTX | EXPERIMENTAL | - |
| Placebo tofacitinib (CP-690,55) plus MTX 10 mg/wk to 20 mg/wk | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Tasocitinib plus Methotrexate | DRUG | Tofacitinib (CP 690,550) 10 mg BID, tablets + methotrexate (MTX) 10 mg/wk to 20 mg/wk, titrated over 2 months |
| Tofacitinib plus placebo methotrexate | DRUG | Tofacitinib (CP-90,550) 10 mg BID, tablets. Placebo to match methotrexate (MTX) capsules titrated as in Treatment Arm 1. |
| Placebo tofacitinib plus Methotrexate | DRUG | Methotrexate (MTX) 10 mg/wk to 20 mg/wk, capsules, titrated over 2 months. Placebo in tablets to match tofacitinib |
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 p...