Phase 2
Completed N=112
Efficacy and Safety Study of MP-435 in Combination With Methotrexate (MTX) in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01143337 ↗Enrolled (actual)
112
Serious AEs
3.0%
Results posted
Oct 2014
Primary outcomePrimary: Percentage of Participants Achieving American College of Rheumatology 20 (ACR 20) Response — 10.9; 19.1; 24.4; 39.1 percentage of participants
Summary
The purpose of this study is to determine the Efficacy, Safety, and Pharmacokinetics of MP-435 administered for 12 weeks in subjects with rheumatoid arthritis (RA) on stable doses of Methotrexate.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving American College of Rheumatology 20 (ACR 20) Response |
10.9; 19.1; 24.4; 39.1; 23.3; 39.0 | — |
| SECONDARY Percentage of Participants Achieving ACR 50 Response |
4.3; 2.1; 8.9; 4.3; 7.0; 12.2 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70 (ACR 70) Response |
0.0; 0.0; 2.2; 0.0; 2.3; 0.0 | — |
| SECONDARY Changes From the Pretreatment Values in the Disease Activity Score (DAS) 28, and ACR Components |
4.18; 4.41; 3.48; 3.54; 5.59; 5.8 | — |
| SECONDARY Percent Changes From the Pretreatment Values in the Disease Activity Score (DAS) 28, and ACR Components |
33.72; 36.94; 35.74; 44.44; -2.14; -6.67 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with a diagnosis of RA according to the diagnostic criteria of the American College of Rheumatology (ACR) (revised in 1987) for at least 6 months.
- Subjects who inadequately response for stable dose of MTX.
Exclusion Criteria
- Patients with Class IV functional activity by the Steinbrocker's scale.
- Patients who have received a biological agent in the past.
- Patients who have other rheumatic diseases, or who have other diseases with joint symptoms.
- Patients with severe or uncontrolled endocrine, psychiatric, cardiac, hematological, pulmonary, hepatic, kidney, gastrointestinal, or thyroid disease.
Data sourced from ClinicalTrials.gov (NCT01143337). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.