MedTrace Logo

A Dose Range Finding Study of JNJ-39758979 in Patients With Active Rheumatoid Arthritis Currently Treated With Methotrexate

NCT01480388 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-12-01

No results posted yet for this study

Summary

The purpose of the study is to assess the efficacy, safety and tolerability of JNJ-39758979 at doses of 10, 30, 100, and 300 mg/day compared with placebo (inactive medical substance) in patients with active rheumatoid arthritis despite concomitant treatment with methotrexate (MTX).

Conditions

  • Active Rheumatoid Arthritis; Rheumatoid Arthritis

Interventions

DRUG

Placebo/JNJ-39758979 (300 mg/d)

Form = tablet, route = oral adminstration placebo once daily from Week 0 to Week 24 followed by JNJ-39758979 300 mg once daily from Week 24 to Week 48.

DRUG

JNJ-39758979 (10 mg)

Form = tablet, route = oral adminstration once daily up to 48 weeks

DRUG

JNJ-39758979 (30 mg)

Form = tablet, route = oral adminstration once daily up to 48 weeks

DRUG

JNJ-39758979 (100 mg)

Form = tablet, route = oral adminstration once daily up to 48 weeks

DRUG

JNJ-39758979 (300 mg)

Form = tablet, route = oral adminstration once daily for 48 weeks

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Development, L.L.C. Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-03-31
Completion
2014-03-31

More Related Trials

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 NCT01480388 on ClinicalTrials.gov