Adults 18 to 75, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of Participants Who Achieved American College of Rheumatology-20 (ACR20) ResponsePrimary· Day 84
ACR 20 response: greater than or equal to (\>=) 20 percent (%) improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with \>=20% improvement in at least 3 of the following: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI); and 5) acute phase reactant as measured by high-sensitivity C-reactive prote
Group
Value
95% CI
Placebo: Double-Blind Treatment Period
0.42
M2951: Double-Blind Treatment Period
0.52
Mean Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Day 28Secondary· Baseline, Day 28
Mean change in the hsCRP concentration from baseline at Day 28 was reported.
Group
Value
95% CI
Placebo: Double-Blind Treatment Period
-0.80
± 2.00
M2951: Double-Blind Treatment Period
-2.72
± 1.93
Proportion of Participants Achieving American College of Rheumatology-50 (ACR50) ResponseSecondary· Day 28, Day 56 and Day 84
ACR 50 response: \>=50% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with \>=50% improvement in at least 3 of the following: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function measured by HAQ-DI; and 5) acute phase reactant as measured by hsCRP. Proportion of ACR50 responders = Number of participants with ACR50 response divided by total participants.
Day 28
Group
Value
95% CI
Placebo: Double-Blind Treatment Period
0.10
M2951: Double-Blind Treatment Period
0.06
Day 56
Group
Value
95% CI
Placebo: Double-Blind Treatment Period
0.23
M2951: Double-Blind Treatment Period
0.18
Day 84
Group
Value
95% CI
Placebo: Double-Blind Treatment Period
0.23
M2951: Double-Blind Treatment Period
0.21
Proportion of Participants Achieving American College of Rheumatology-70 (ACR70) ResponseSecondary· Day 28, Day 56 and Day 84
ACR 70 response: \>=70% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with \>=70% improvement in at least 3 of the following: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function measured by HAQ-DI; and 5) acute phase reactant as measured by hsCRP. Proportion of ACR70 responders = Number of participants with ACR70 response divided by total participants.
Day 28
Group
Value
95% CI
Placebo: Double-Blind Treatment Period
0.00
M2951: Double-Blind Treatment Period
0.06
Day 56
Group
Value
95% CI
Placebo: Double-Blind Treatment Period
0.03
M2951: Double-Blind Treatment Period
0.06
Day 84
Group
Value
95% CI
Placebo: Double-Blind Treatment Period
0.13
M2951: Double-Blind Treatment Period
0.09
Mean Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Day 84Secondary· Baseline, Day 84
Mean change in the hsCRP concentration from baseline at Day 84 was reported.
Group
Value
95% CI
Placebo: Double-Blind Treatment Period
-2.14
± 2.20
M2951: Double-Blind Treatment Period
-3.54
± 2.13
Mean Change From Baseline in Disease Activity Score Based on a 28 Joint Count High-Sensitivity C-Reactive Protein (DAS28-hsCRP) at Day 28 and 84Secondary· Baseline, Day 28 and Day 84
Disease Activity Score (DAS) based on a 28 joint count hsCRP consisted of composite numerical score of following variables: tender joint count (TJC28), swollen joint count (SJC28), hsCRP (mg/mL), and participant's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP equals to (=) 0.56\*square root (sqrt) (TJC28) plus (+) 0.28\*sqrt (SJC28)+ 0.014\* participant's global assessment of disease activity + 0.36\*natural log(hsCRP+1) +0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.
Change at Day 28
Group
Value
95% CI
Placebo: Double-Blind Treatment Period
-0.79
± 0.14
M2951: Double-Blind Treatment Period
-0.87
± 0.13
Change at Day 84
Group
Value
95% CI
Placebo: Double-Blind Treatment Period
-1.35
± 0.20
M2951: Double-Blind Treatment Period
-1.28
± 0.19
Proportion of Participants With Disease Activity Score- High Sensitivity C-Reactive Protein (DAS28-hsCRP) Value Less Than (<) 3.2Secondary· Day 84
DAS28-hsCRP consisted of composite score of following variables: TJC28, SJC28, hsCRP (mg/mL), and participant's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP =0.56\* sqrt(TJC28) + 0.28\*sqrt(SJC28)+ 0.014\* participant's global assessment of disease activity + 0.36\*natural log(hsCRP+1) +0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity. Proportion of participants with DAS28-hsCRP value \<3.2 were reported.
Group
Value
95% CI
Placebo: Double-Blind Treatment Period
0.13
M2951: Double-Blind Treatment Period
0.21
Proportion of Participants With Disease Activity Score- High Sensitivity C-Reactive Protein (DAS28-hsCRP) Value Less Than (<) 2.6Secondary· Day 84
DAS28 consisted of composite score of following variables: TJC28, SJC28, hsCRP (mg/mL), and participant's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP =0.56\* sqrt (TJC28) + 0.28\*sqrt (SJC28)+ 0.014\* participant's global assessment of disease activity + 0.36\*natural log(hsCRP+1) +0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity. Proportion of participants with DAS28-hsCRP value \<2.6 were reported.
Group
Value
95% CI
Placebo: Double-Blind Treatment Period
0.10
M2951: Double-Blind Treatment Period
0.06
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 28 and 84Secondary· Baseline, Day 28 and Day 84
Erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. Higher values indicate inflammation in the body.
Change at Day 28
Group
Value
95% CI
Placebo: Double-Blind Treatment Period
-3
± 36.9
M2951: Double-Blind Treatment Period
-7
± 22.1
Change at Day 84
Group
Value
95% CI
Placebo: Double-Blind Treatment Period
-3
± 21.0
M2951: Double-Blind Treatment Period
-9
± 21.1
Change From Baseline in Anti-cyclic Citrullinated Peptide (Anti-CCP) Antibody Levels at Day 28 and 84Secondary· Baseline, Day 28 and Day 84
Anti-cyclic citrullinated peptide (anti-CCP) is an antibody present in most rheumatoid arthritis participants.
Change at Day 28
Group
Value
95% CI
Placebo: Double-Blind Treatment Period
168
± 991.1
M2951: Double-Blind Treatment Period
-138
± 720.9
Change at Day 84
Group
Value
95% CI
Placebo: Double-Blind Treatment Period
301
± 1282.6
M2951: Double-Blind Treatment Period
-396
± 736.8
Change From Baseline in Rheumatoid Factor (RF) at Day 28 and 84Secondary· Baseline, Day 28 and Day 84
Rheumatoid Factor is an anti-body present in the blood.
Change at Day 28
Group
Value
95% CI
Placebo: Double-Blind Treatment Period
-30
± 124.2
M2951: Double-Blind Treatment Period
-7
± 59.7
Change at Day 84
Group
Value
95% CI
Placebo: Double-Blind Treatment Period
-34
± 132.1
M2951: Double-Blind Treatment Period
-26
± 79.9
Change From Baseline in Global Assessment of Disease Activity Based on Visual Analog Scale (VAS) Score at Day 84Secondary· Baseline, Day 84
The participant's overall assessment of disease activity was recorded using the 100 millimeter (mm) horizontal visual analog scale (VAS). The scale ranged from 0-100 mm, where 0 indicated no disease activity (symptom free and no arthritis symptoms) and 100 represented maximum disease activity (maximum arthritis disease activity).
Group
Value
95% CI
Placebo: Double-Blind Treatment Period
-21
± 23.5
M2951: Double-Blind Treatment Period
-24
± 24.6
Adverse events — posted to ClinicalTrials.gov
Time frame: Double-Blind Period: Baseline up to 16 weeks; Open-Label Period: Baseline up to 30 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04697511 — Drug-drug Interaction Study of Evobrutinib With Midazolam in Healthy Participants
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NCT02975336 — A Phase II Study of M2951 in SLE
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by EMD Serono Research & Development Institute, Inc.
Last refreshed: 17 July 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02784106.