Rheumatoid Arthritis
Conditions
Interventions
- High-dose tulisokibart group: Subcutaneous administration of high-dose tulisokibart in addition to methotrexate background therapy.
- Medium-dose tulisokibart group: Subcutaneous administration of m
Sponsors
Iwamoto Taro
Eligibility
Inclusion criteria
Inclusion criteria: - Has a clinical diagnosis of rheumatoid arthritis (RA) and fulfillment of 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria - Has active disease defined as >=6 tender joints (based on 68 joints) and >=6 swollen joints (based on 66 joints) - Has current treatment with oral or parenteral methotrexate therapy - Has history of one of the following: a) biologic disease-modifying antirheumatic drug (bDMARD) naive, or b) bDMARD-Inadequate Response (IR)/intolerant up to a maximum of 2 classes of bDMARDS
Exclusion criteria
Exclusion criteria: - Has any arthritis with onset before age 17 years or current diagnosis of inflammatory joint disease other than RA (such as, but not limited to, psoriatic arthritis, systemic lupus erythematosus, gout, systemic sclerosis, myositis, pseudogout, etc) or any other condition that may, in the judgment of the investigator, interfere with the assessment of RA - Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years before randomization - Has any active infection - Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Proportion of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| - Proportion of Participants Achieving American College of Rheumatology 50% Response Criteria (ACR50) at Week 12 - Proportion of Participants Achieving American College of Rheumatology 70% Response Criteria (ACR70) at Week 12 - Proportion of Participants Achieving Low Disease Activity (LDA) based on Disease Activity Score 28 Using C-Reactive Protein (DAS28-CRP) - Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 12 - Number of Participants Who Experience One or More Adverse Events (AEs) - Number of Participants Who Discontinue Study Intervention Due to an AE | — |
Countries
Canada, Chile, China, Columbia, Germany, Japan, Poland, South Korea, Spain, UK, USA
Contacts
Public ContactMSDJRCT inquiry mailbox
MSD K.K.
Outcome results
None listed