A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061 administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with active rheumatoid arthritis (RA) despite MTX therapy, compared with placebo.

To assess the effects of ALX-0061 on quality of life, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061, and to define the optimal dose regimen for ALX-0061, based on safety and efficacy, for further clinical development.

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

Details

• Lead Sponsor: Ablynx
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• Diagnosis of RA for at least 6 months prior to screening, and American College of Rheumatology (ACR) functional class I-III

• Subjects treated with and tolerating MTX

• Active RA

• Others as defined in the protocol

Exclusion Criteria:

• Have been treated with disease-modifying antirheumatic drugs (DMARDs)/systemic immunosuppressives other than MTX.

• Have received approved or investigational biological or targeted synthetic DMARD therapies for RA less than 6 months prior to screening.

• Have a history of toxicity, non-tolerance, primary non-response or inadequate response to a biological therapy, or targeted synthetic DMARDs, for RA.

• Have received prior therapy blocking the interleukin-6 (IL-6) pathway, at any time.

• Others as defined in the protocol