MSB11022 in Moderate to Severe Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2018-08-27
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy, safety and immunogenicity of MSB11022 and Humira® in adult participants with rheumatoid arthritis (RA).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fresenius Kabi SwissBioSim GmbH; Merck KGaA
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

• Diagnosis of rheumatoid arthritis based on 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria

• At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline

• Must have received methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose

• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• Evidence of untreated or inadequately treated latent or active Tuberculosis

• Evidence of uncontrolled, clinically significant diseases

• Any second disease-modifying antirheumatic drugs must be washed out prior to the first study dose

• Other protocol defined exclusion criteria could apply