The purpose of the study is to compare the efficacy, safety and immunogenicity of MSB11456 and EU approved RoActemra® in participants with moderately to severely active rheumatoid arthritis. Participants will be randomized at the beginning of the Core Treatment Period (Baseline to Week 24) to receive either MSB11456 or EU approved RoActemra® once a week (QW). At the beginning of the Extended Treatment Period (Week 24 to Week 52), participants who received RoActemra® will be re-randomized to either continue receiving RoActemra® QW or switch to receive MSB11456 QW.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
604
Participants will receive MSB11456 subcutaneously, once a week.
Participants will receive EU-approved RoActemra® subcutaneously, once a week.
Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
The DAS28-ESR is a measure of disease activity in 28 joints that consists of a composite numerical score of the following variables: Tender Joint Count (TJC), Swollen Joint Count (SJC), erythrocyte sedimentation rate (ESR) and Patient's Global Assessment of Disease Activity. The DAS28-ESR score was derived using the formula: DAS28-ESR = 0.56\*√(TJC28) + 0.28\*√(SJC28) + 0.014\*GH + 0.70\*Ln(ESR), where, TJC28 = 28 joint count for tenderness, SJC28 = 28 joint count for swelling, Ln(ESR) = natural logarithm of ESR, GH = the general health component of the DAS (i.e., Patient's Global Assessment of Disease Activity on a scale of 1 to 100 where 100 is maximal activity). Higher values mean a higher disease activity. The level of disease activity can be interpreted as: * Remission (score of \<2.6). * Low (score of ≤2.6 to \<3.2). * Moderate (score of ≤3.2 to ≤5.1). * High (score of \>5.1) A negative change from baseline indicates an improvement.
Time frame: Baseline; Week 24
Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
The DAS28-ESR is a measure of disease activity in 28 joints that consists of a composite numerical score of the following variables: TJC, SJC, ESR and Patient's Global Assessment of Disease Activity. The DAS28-ESR score was derived using the formula: DAS28-ESR = 0.56\*√(TJC28) + 0.28\*√(SJC28) + 0.014\*GH + 0.70\*Ln(ESR), where, TJC28 = 28 joint count for tenderness, SJC28 = 28 joint count for swelling, Ln(ESR) = natural logarithm of ESR, GH = the general health component of the DAS (i.e., Patient's Global Assessment of Disease Activity on a scale of 1 to 100 where 100 is maximal activity). Higher values mean a higher disease activity. The level of disease activity can be interpreted as: * Remission (score of \<2.6). * Low (score of ≤2.6 to \<3.2). * Moderate (score of ≤3.2 to ≤5.1). * High (score of \>5.1) A negative change from baseline indicates an improvement. For weeks 30, 42 and 52, the extended baseline (week 24) was used for the change in DAS28-ESR calculation.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16; Extended Period Baseline (Week 24), Week 30, Week 42, and Week 52
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Number of Participants With 20% Improvement in American College of Rheumatology (ACR20) Response
ACR20 was defined as the number of participants with at least 20% improvement from baseline in number of tender and swollen joints (68/66 joint count), and at least 20% improvement from baseline in three or more of the 5 ACR Core Set measures: * Patient's Assessment of Arthritis Pain * Physical Function Assessment (Health Assessment Questionnaire-Disability Index) * Acute phase reactant level (erythrocyte sedimentation rate or C-reactive protein) * Patient's Global Assessment of Disease Activity and * Physician's Global Assessment of Disease Activity
Time frame: Baseline; Week 24
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Event (TEAE)
Time frame: Baseline to end of study, up to Week 63
Number of Participants Who Experienced One or More Treatment-Emergent Serious Adverse Event (TESAE)
Time frame: Baseline to end of study, up to Week 63
Percentage of Participants With Positive Anti-Drug Antibodies (ADAs)
Time frame: Baseline, Week 2, Week 12, Week 24, Week 30, Week 52 and Week 55
Anti-Drug Antibodies (ADAs) Titer Levels
Time frame: Baseline, Week 2, Week 12, Week 24, Week 30, Week 52 and Week 55
Percentage of Participants With Neutralizing Antibodies (NAb)
Time frame: Baseline, Week 2, Week 12, Week 24, Week 30, Week 52 and Week 55