A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha Therapy

• Status: Terminated
• Trial end date: 2018-11-06
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase IIa/b double-blind, placebo-controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of RO7123520 as adjunctive therapy in participants with RA who are inadequately responding to standard-of-care (methotrexate and anti-TNF-alpha therapy). Part 1 of the study will evaluate safety. Part 2 will evaluate efficacy and safety. Part 3 will evaluate dose-ranging efficacy. Participants will have the option of continuing to the extension period of the study.

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

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• Diagnosis of adult-onset RA as defined by the ACR 2010 criteria, for at least 6 months before screening

• Moderately to severely active RA as defined by at least 4/28 tender joints and at least 4/28 swollen joints, and a DAS28 greater than or equal to (≥) 3.2

• For Part 2 only: Active synovitis and/or osteitis as determined by contrast-enhanced magnetic resonance imaging

• Participants must be taking stable dose of anti-TNF-alpha therapies

• Participants on stable oral glucocorticoids within 6 weeks of planned randomization

• Participants taking non-steroidal anti-inflammatory drugs (NSAIDs) intermittently (up to 2-3 times weekly) for short-term relief of pain and participants on regular NSAID use (on stable dose for ≥ 4 weeks)

Exclusion Criteria:

• Parenteral glucocorticoids administration (intramuscular, IV) of ≥50 mg within 6 weeks or less than or equal to (≤) 50 milligrams (mg) within 4 weeks prior to planned randomization, or scheduled parenteral administrations during the study

• Joint(s) injected with intra-articular glucocorticoids or hyaluronic acid within 6 weeks prior to planned randomization

• Active inflammatory diseases of the joints not related to RA

• Systemic autoimmune disease other than RA

• Juvenile idiopathic arthritis or juvenile RA and/or RA developed before the age of 16

• Active fibromyalgia that makes appropriate assessment of RA disease activity challenging in the opinion of the Investigator

• RA participants functional status class IV according to the ACR 1991 criteria

• Participants with severe chronic or recurrent viral, bacterial, parasitic, or fungal infections

• History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection

• Any identified confirmed congenital or acquired immunodeficiency

• Abnormal laboratory values and liver function test

• Myocardial infarction within less than 6 months prior to participation in the study

• Severe central or peripheral nervous system diseases