A Study to Evaluate the Safety and Efficacy of SM03 in Patients With Rheumatoid Arthritis Receiving Methotrexate

• Status: Completed
• Trial end date: 2016-02-03
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluated the safety and efficacy of SM03 compared to placebo in patients with active rheumatoid arthritis(RA) receiving methotrexate

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SinoMab Pty Ltd
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• Adult patients 18-75 years of age.

• Rheumatoid arthritis (RA) for ≥ 12 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis.

• Moderate to severe active RA with swollen joint count (SJC) ≥ 8 (66 joint count), and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.

• At screening, either C-reactive protein (CRP) ≥ 0.6 mg/dL (6 mg/L), or Erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour, or Morning stiffness of joint for ≥ 45 minutes

• Inadequate response to methotrexate, having received and tolerated at a dose of 7.5-20 mg/week for ≥ 12 weeks, at a stable dose over the past 4 weeks.

Exclusion Criteria:

• Rheumatic autoimmune disease other than RA.

• Use of any biological DMARDs for RA within past 6 months.

• Concurrent treatment with any Disease Modifying Anti-Rheumatic Drug (DMARD) other than methotrexate

• Active infection, or history of serious or chronic infection