Trials / Completed
CompletedNCT03052322
MSB11022 in Moderate to Severe Rheumatoid Arthritis
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 288 (actual)
- Sponsor
- Fresenius Kabi SwissBioSim GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MSB11022 | Participants received MSB11022 (modified buffer and stabilizer) subcutaneously at dose of 40 milligram (mg) every other week from Day 1 up to Week 48. |
| DRUG | EU-Humira | Participants received EU-Humira subcutaneously at dose of 40 mg every other week from Day 1 up to Week 48. |
Timeline
- Start date
- 2017-01-31
- Primary completion
- 2018-05-28
- Completion
- 2018-08-27
- First posted
- 2017-02-14
- Last updated
- 2019-12-20
- Results posted
- 2019-04-23
Locations
46 sites across 6 countries: Bulgaria, Czechia, Germany, Hungary, Poland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03052322. Inclusion in this directory is not an endorsement.