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Safety and Efficacy of MK-8457 and Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Despite MTX Therapy (P08683, MK-8457-008)

NCT01569152 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2019-03-27

Study results available
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Summary

The purpose of this study is to assess the safety and efficacy of MK-8457 + Methotrexate (MTX) in participants with active rheumatoid arthritis (RA) despite MTX therapy. The primary hypothesis is that at least 1 dose of MK-8457 + MTX will be superior to placebo + MTX as measured by the percentage of participants who achieve American College of Rheumatology 20 (ACR 20) response after 12 weeks of treatment.

Conditions

  • Rheumatoid Arthritis (RA)

Interventions

DRUG

MK-8457 100 mg

MK-8457 100 mg dosed orally BID

DRUG

Dose-Matched Placebo

Dose-matched placebo dosed orally BID

DRUG

Methotrexate

MTX dosed at the stable dose receive upon study entry

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-22
Primary Completion
2013-10-03
Completion
2013-10-03

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01569152 on ClinicalTrials.gov