Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent of patients don't respond to current treatments. MBS2320, the drug being tested in this trial, represents a new approach to treating RA, with the potential not only to reduce levels of inflammation but to also directly prevent bone damage. The aim of this project is to test the safety, tolerability and efficacy of MBS2320 in patients with RA in combination with an existing treatment, methotrexate. Approximately 224 participants with moderate to severe active RA who have not responded to treatment with Methotrexate will be enrolled from around 45 to 55 sites around the world. Participants will be randomly assigned to receive 1 of 3 doses of MBS2320 (5 mg, 20 mg, or 40 mg) or placebo (a "dummy" drug). The maximum duration of study participation for a participant will be 22 weeks, which consists of a Screening Period of up to 4 weeks, Treatment Period of 12 weeks, and a Follow-up Period of 6 weeks. Participants on the study will be asked to attend the hospital or clinic for regular visits during which they will have planned study assessments to evaluate the effectiveness, tolerability and safety of the study drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
248
Oral capsule
Oral capsule
Oral capsule
Oral capsule
Site 1201 - Univerzitetski Klinicki Centar Republike Srpske
Banja Luka, Bosnia and Herzegovina
Site 1204 - Univerzitetski Klinicki Centar Republike Srpske
Banja Luka, Bosnia and Herzegovina
Site 1202 - General Hospital Gradiška
Gradiška, Bosnia and Herzegovina
Site 1308 - Medical Center Medconsult Pleven OOD
Pleven, Bulgaria
Site 1302 - Medical Center Artmed OOD
Plovdiv, Bulgaria
Percentage of Participants Achieving a Successful Composite Clinical Response According to the Criteria for American College of Rheumatology 20% Response (ACR20)
Achieving clinical response according to the criteria for ACR20: * ≥20% improvement in 68-Tender Joint Count; * ≥20% improvement in 66-SJC; and * ≥20% improvement in at least 3 of the 5 following parameters: 1. Physician's global assessment of disease activity 2. Participant's global assessment of disease activity 3. Participant's assessment of arthritis pain 4. Health Assessment Questionnaire - Disability Index (HAQ-DI) 5. High-sensitivity C-reactive protein (hsCRP)
Time frame: Week 12
Safety and Tolerability of MBS2320
Incidence of all grade adverse events
Time frame: Week 12
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Site 1303 - Diagnostic and Consulting Center Aleksandrovska EOOD
Sofia, Bulgaria
Site 1306 - Diagnostic- Consultative Center Convex EOOD
Sofia, Bulgaria
Site 1307 - Medical Center Excelsior OOD - PPDS
Sofia, Bulgaria
Site 1301 - University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD
Stara Zagora, Bulgaria
Site 1304 - Medical Center Leo Clinic EOOD, Varna
Varna, Bulgaria
...and 36 more locations