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A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate the Safety and Efficacy of Oral TAK-783 in the Treatment of the Signs and Symptoms in Subjects With Rheumatoid Arthritis
The purpose of this study is to determine the efficacy and safety of TAK-783, once daily (QD), taken in combination with methotrexate in subjects with rheumatoid arthritis.
Details
| Lead sponsor | Takeda |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 224 |
| Start date | 2007-08 |
| Completion | 2009-02 |
Conditions
- Arthritis, Rheumatoid
Interventions
- TAK-783 and methotrexate
- Methotrexate
Primary outcomes
- Percent of subjects with greater than or equal to 20% improvement in Arthritis Signs and Symptoms according to the American College of Rheumatology — Weeks 2, 4, 8, and 12 or Final Visit.
- Change from Baseline in Treatment-emergent adverse events. — Weeks 2, 4, 8, and 12 or Final Visit.
- Change from Baseline in Vital signs. — Weeks 2, 4, 8, and 12 or Final Visit.
- Change from Baseline in Electrocardiogram findings. — Weeks 2, 4, 8, and 12 or Final Visit.
- Change from Baseline in Spirometry tests. — Weeks 2, 4, 8, and 12 or Final Visit.
- Change from Baseline in Hematology Laboratory tests. — Weeks 2, 4, 8, and 12 or Final Visit.
Countries
Czechia, Latvia, Romania, Russia, Slovakia, Ukraine