Phase 3
N=288
MSB11022 in Moderate to Severe Rheumatoid Arthritis
Moderate to Severe Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT03052322 ↗Enrolled (actual)
288
Serious AEs
8.0%
Results posted
Apr 2019
Primary outcome: Primary: Percentage of Participants With Treatment-emergent Adverse Events of Special Interest (AESI) — 4.2; 5.5 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MSB11022 (Drug); EU-Humira (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fresenius Kabi SwissBioSim GmbH
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-emergent Adverse Events of Special Interest (AESI) |
4.2; 5.5 | — |
| SECONDARY Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Response at Week 12 |
79.6; 80.9 | — |
| SECONDARY Percentage of Participants With Positive Anti-Drug Antibodies (ADAs) Status to Adalimumab |
7.7; 4.2; 20.3; 15.2; 29.8; 21.3 | — |
| SECONDARY Anti-Drug Antibodies (ADAs) Titer Levels for Adalimumab |
4.0; 1.5; 4.0; 12.0; 6.0; 6.0 | — |
| SECONDARY Percentage of Participants With Confirmed Neutralizing Antibodies (NAb) Status to Adalimumab |
45.5; 50.0; 31.0; 40.9; 33.3; 30.0 | — |
| SECONDARY Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Response at Week 2, 4, 8, 24 and 52 |
30.0; 29.7; 52.1; 52.8; 71.1; 72.9 | — |
| SECONDARY Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Response at Week 2, 4, 8, 12, 24 and 52 |
6.4; 6.2; 17.6; 19.4; 40.8; 34.7 | — |
| SECONDARY Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Response at Week 2, 4, 8, 12, 24 and 52 |
0.7; 0.7; 4.9; 2.8; 14.8; 12.5 | — |
| SECONDARY 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 |
-0.9; -0.7; -1.4; -1.2; -1.9; -1.7 | — |
| SECONDARY 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 |
10.0; 8.3; 20.6; 16.0; 33.1; 33.3 | — |
| SECONDARY Change From Baseline in Simplified Disease Activity Index (SDAI) Total Score at Week 2, 4, 8, 12, 24, and 52 |
-11.5; -9.1; -18.0; -16.0; -24.0; -21.4 | — |
| SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) Total Score at Week 2, 4, 8, 12, 24 and 52 |
-10.8; -8.5; -17.4; -15.2; -23.5; -20.6 | — |
| SECONDARY 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 |
0.7; 0.0; 0.7; 1.4; 3.5; 4.2 | — |
| SECONDARY Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death |
58.0; 64.1; 4.9; 9.7; 0; 0.7 | — |
| SECONDARY Percentage of Participants With Clinically Meaningful Differences in Vital Signs |
0; 0 | — |
| SECONDARY Percentage of Participants With Clinically Meaningful Differences in Laboratory Values |
0; 0 | — |
| SECONDARY Percentage of Participants With Clinically Significant Abnormal Values for 12-lead Electrocardiogram (ECG) at Week 12, 24, and 52 |
0; 0; 0; 1.5; 0; 0.8 | — |
| SECONDARY Percentage of Participants With Anti-Nuclear Antibody (ANA) and Anti Double-stranded Deoxyribonucleic Acid (Anti-dsDNA) at Baseline, Week 24 and 52 |
97.2; 95.1; 2.8; 4.9; 92.0; 91.6 | — |
| SECONDARY Health Assessment Questionnaire Disability Index (HAQ-DI) Total Score at Baseline, Weeks 12, 24 and 52 |
1.6; 1.6; 1.1; 1.1; 1.0; 1.0 | — |
| SECONDARY Short-Form Health Survey- 36 Items (SF-36) at Baseline, Week 12, 24 and 52 |
30.3; 30.6; 39.0; 38.6; 40.5; 40.8 | — |
| SECONDARY Euro-Quality of Life - 5 Dimension-5 Levels (EQ-5D-5L) Utility Index Score at Baseline, Week 12, 24 and 52 |
0.6; 0.6; 0.8; 0.8; 0.8; 0.8 | — |
| SECONDARY Euro-Quality of Life - 5 Dimension-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Baseline, Week 12, 24 and 52 |
42.4; 45.4; 64.6; 63.2; 66.2; 65.6 | — |
| SECONDARY Mean Change From Baseline (Week 4) in Injection Site Pain as Assessed by Visual Analogue Scale (VAS) at Week 6 and 8 |
-1.4; -1.3; -0.2; 0.4; 0.0; 0.0 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03052322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.