CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 288 enrolled
Drug / intervention
MSB11022 +1 moredrug
Likely dose
MSB11022 40 mg subcutaneously every other weekAI-extracted
Key inclusion· 3
  • ✓Rheumatoid arthritis diagnosed by 2010 ACR/EULAR criteria
  • ✓At least 6 tender and 6 swollen joints at screening and baseline
  • ✓Methotrexate for ≥12 weeks with stable dose for ≥4 weeks before first study dose
Key exclusion· 3
  • ✕Untreated or inadequately treated latent or active tuberculosis
  • ✕Uncontrolled, clinically significant diseases
  • ✕Prior non-MTX disease-modifying antirheumatic drugs must be washed out before first dose

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03052322
NCT03052322Phase 3Completed
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A Multicenter, Randomized, Double-blind, Phase III Trial to Evaluate the Safety, Immunogenicity, and Efficacy of MSB11022 Compared With Humira® in Patients With Moderately to Severely Active Rheumatoid Arthritis

Fresenius Kabi SwissBioSim GmbH·interventional·Posted Feb 14, 2017·Updated Dec 20, 2019

In Brief

A Phase 3 clinical trial evaluating MSB11022 and EU-Humira for Moderate to Severe Rheumatoid Arthritis. Completed, enrolled 288 participants across 46 sites in 6 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsModerate to Severe Rheumatoid Arthritis
CountriesBulgaria, Czechia, Germany, Hungary, Poland, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 14, 2017
Enrollment StartJan 31, 2017
Primary CompletionMay 28, 2018
Study CompletionAug 27, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.4 years ago

Interventions

MSB11022drug

Participants received MSB11022 (modified buffer and stabilizer) subcutaneously at dose of 40 milligram (mg) every other week from Day 1 up to Week 48.

EU-Humiradrug

Participants received EU-Humira subcutaneously at dose of 40 mg every other week from Day 1 up to Week 48.