CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 65 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
M2951 50 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02784106
NCT02784106Phase 2Completed
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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

EMD Serono Research & Development Institute, Inc.·interventional·Posted May 26, 2016·Updated Jul 17, 2018

In Brief

A Phase 2 clinical trial evaluating Placebo and M2951 for Rheumatoid Arthritis. Completed, enrolled 65 participants across 2 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesGermany, United States
CollaboratorsMerck KGaA, Darmstadt, Germany

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 26, 2016
Enrollment StartJul 31, 2016
Primary CompletionApr 30, 2017
Study CompletionNov 14, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.1 years ago

Interventions

Placebodrug

Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.

M2951drug

Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.

M2951drug

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.