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MSB11022 in Moderate to Severe Rheumatoid Arthritis

NCT03052322 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2019-12-20

Study results available
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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

  • Moderate to Severe Rheumatoid Arthritis

Interventions

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.

Sponsors & Collaborators

  • Fresenius Kabi SwissBioSim GmbH

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Fresenius Kabi SwissBioSim GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-05-28
Completion
2018-08-27
FDA Drug
Yes

Countries

  • Bulgaria
  • Czechia
  • Germany
  • Hungary
  • Poland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03052322 on ClinicalTrials.gov