NCT03052322CompletedPhase 3
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 GmbH45 sites in 6 countries288 target enrollmentStarted: January 31, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 288
- Locations
- 45
- Primary Endpoint
- Percentage of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)
Study Overview
Brief 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
MSB11022
Experimental
Intervention: MSB11022 (Drug)
EU-Humira
Active Comparator
Intervention: EU-Humira (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)
Time Frame: Up to Week 52
Adverse event (AE) was defined as any untoward medical occurrence in participants, which does not necessarily have causal relationship with treatment. Term Treatment-emergent Adverse Events (TEAE) is defined as AEs starting/worsening after first intake of the study drug. Hypersensitivity was the pre-defined TEAE of special Interest for this study. The percentage of participants with treatment emergent AESIs (hypersensitivity) were reported.
Secondary Outcomes
- Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Response at Week 2, 4, 8, 12, 24 and 52(Week 2, 4, 8, 12, 24 and 52)
- Change From Baseline in Simplified Disease Activity Index (SDAI) Total Score at Week 2, 4, 8, 12, 24, and 52(Baseline, Week 2, 4, 8, 12, 24, and 52)
- Mean Change From Baseline (Week 4) in Injection Site Pain as Assessed by Visual Analogue Scale (VAS) at Week 6 and 8(Immediately, 15 minutes and 1 hour post-injection on Baseline (Week 4), Week 6 and 8)
- Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Response at Week 12(Week 12)
- Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Response at Week 2, 4, 8, 24 and 52(Week 2, 4, 8, 24 and 52)
- Percentage of Participants With Disease Activity Score Based on 28-joints Count- Erythrocyte Sedimentation Rate (DAS28-ESR) Low Disease Activity and Remission at Week 2, 4, 8, 12, 24, and 52(Week 2, 4, 8, 12, 24, and 52)
- Change From Baseline in Clinical Disease Activity Index (CDAI) Total Score at Week 2, 4, 8, 12, 24 and 52(Baseline, Week 2, 4, 8, 12, 24 and 52)
- Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission at Week 2, 4, 8, 12, 24 and 52(Week 2, 4, 8, 12, 24 and 52)
- Percentage of Participants With Clinically Meaningful Differences in Vital Signs(Up to Week 52)
- Euro-Quality of Life - 5 Dimension-5 Levels (EQ-5D-5L) Utility Index Score at Baseline, Week 12, 24 and 52(Baseline, Week 12, 24 and 52)
- Percentage of Participants With Positive Anti-Drug Antibodies (ADAs) Status to Adalimumab(Baseline, Week 2, 4, 12, 24, 36 and 52)
- Anti-Drug Antibodies (ADAs) Titer Levels for Adalimumab(Baseline, Week 2, 4, 12, 24, 36 and 52)
- Percentage of Participants With Confirmed Neutralizing Antibodies (NAb) Status to Adalimumab(Baseline, Week 2, 4, 12, 24, 36 and 52)
- Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Response at Week 2, 4, 8, 12, 24 and 52(Week 2, 4, 8, 12, 24 and 52)
- Percentage of Participants With Clinically Significant Abnormal Values for 12-lead Electrocardiogram (ECG) at Week 12, 24, and 52(Week 12, 24, and 52)
- Change From Baseline in Disease Activity Score Based on a 28 Joint Count- Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Week 2, 4, 8, 12, 24 and 52(Baseline, Week 2, 4, 8, 12, 24 and 52)
- Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death(Baseline up to Week 69)
- Percentage of Participants With Clinically Meaningful Differences in Laboratory Values(Up to Week 52)
- Percentage of Participants With Anti-Nuclear Antibody (ANA) and Anti Double-stranded Deoxyribonucleic Acid (Anti-dsDNA) at Baseline, Week 24 and 52(Baseline, Week 24 and 52)
- Health Assessment Questionnaire Disability Index (HAQ-DI) Total Score at Baseline, Weeks 12, 24 and 52(Baseline, Weeks 12, 24 and 52)
- Short-Form Health Survey- 36 Items (SF-36) at Baseline, Week 12, 24 and 52(Baseline, Week 12, 24 and 52)
- Euro-Quality of Life - 5 Dimension-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Baseline, Week 12, 24 and 52(Baseline, Week 12, 24 and 52)
Investigators
Study Sites (45)
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