NCT02784106

Safety and Efficacy Study of M2951 in Participants With Rheumatoid Arthritis

Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects With Rheumatoid Arthritis on Stable Methotrexate Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

M2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders. The purpose of the study is to assess the efficacy of M2951 in participants with rheumatoid arthritis (RA) currently treated with stable dose of methotrexate (MTX).

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Placebo	Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
DRUG	M2951	Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
DRUG	M2951	Participants who received placebo matched to M2951 or M2951 in double-blind treatment period, received 50 mg M2951 orally twice daily up to 26-weeks during the open label extension period.

Timeline

• Start date: 2016-07-31
• Primary completion: 2017-04-30
• Completion: 2017-11-14
• First posted: 2016-05-26
• Last updated: 2018-07-17
• Results posted: 2018-05-30

Locations

2 sites across 2 countries: United States, Germany