MSB11022 in Moderate to Severe Rheumatoid Arthritis (Auriel-RA)

Fresenius Kabi

Status and phase: Completed; Phase 3

Conditions: Moderate to Severe Rheumatoid Arthritis

Treatments: Drug: MSB11022; Drug: EU-Humira

Study type: Interventional

Funder types: Industry

Identifiers

NCT03052322

MS200588-0004

2016-002852-26 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 288 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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288 participants in 2 patient groups

MSB11022

Experimental group

Treatment:

Drug: MSB11022

EU-Humira

Active Comparator group

Treatment:

Drug: EU-Humira