A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis

Launched by ABLYNX, A SANOFI COMPANY · Nov 10, 2014

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Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of RA (according to the 2010 EULAR/American College of Rheumatology (ACR) classification criteria) for at least 6 months prior to screening, and ACR functional class I-III.
• • Received previous or current treatment with methotrexate (MTX), and is considered intolerant to MTX, or for whom continued treatment with MTX is inappropriate or has contraindications for MTX use.
• • Subjects must not have received MTX for at least 4 weeks before first administration of the study drug.
• • Have active RA with at least 6 swollen and 6 tender joints(66/68 joint count) at the time of screening and baseline
• • Others as defined in the protocol
• Exclusion Criteria:
• • Have been treated with DMARDs (Disease Modifying Antirheumatic Drugs)/systemic immunosuppressive drugs during the 4 weeks, or 12 weeks for hydroxychloroquine, chloroquine, or leflunomide (except when an adequate wash-out procedure for leflunomide was completed), prior to first administration of study drug.
• • Have received approved or investigational biological or targeted synthetic DMARD therapies for RA (including tumor necrosis factor alpha-inhibitors, abatacept, rituximab, or Janus kinase \[JAK\]-inhibitors) 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 (including JAK inhibitors), for RA.
• • Have received prior therapy blocking the interleukin-6 (IL-6) pathway, at any time.
• • Others as defined in the protocol.