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A Dose Range Finding Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis in Spite of Treatment With Methotrexate

NCT01679951 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2019-03-18

No results posted yet for this study

Summary

The purpose of this dose range finding study is to assess the effectiveness, safety and tolerability of JNJ-38518168 at doses of 3, 10, and 30 mg/d compared with placebo in patients with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy.

Conditions

Interventions

DRUG

Placebo

Form=tablet, route=oral. Placebo will be administered once daily from week 0 to week 24.

DRUG

JNJ-38518168 (3 mg)

Type=exact number, unit=mg, number=3, form=tablet, route=oral. JNJ-38518168 will be administered once daily up to 24 weeks.

DRUG

JNJ-38518168 (10 mg)

Type=exact number, unit=mg, number=10, form=tablet, route=oral. JNJ-38518168 will be administered once daily up to 24 weeks.

DRUG

JNJ-38518168 (30 mg)

Type=exact number, unit=mg, number=30, form=tablet, route=oral. JNJ-38518168 will be administered once daily up to 24 weeks.

DRUG

Methotrexate

Participants must have been treated with and tolerated Methotrexate (MTX) treatment at dosages from 10 to 25 milligram per week (mg/week) inclusive, for a minimum of 6 months prior to the date of signing the informed consent at screening and must have a stable MTX dose for a minimum of 8 weeks prior to the date of signing the informed consent at screening and continue to receive the same MTX dose at Week 0 through Week 24.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research and Development, LLC Clinical Trial · Janssen Research and 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
2012-10-31
Primary Completion
2014-04-17
Completion
2014-07-03
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Chile
  • Colombia
  • Czechia
  • Hungary
  • Japan
  • Latvia
  • Mexico
  • Poland
  • Romania
  • Russia
  • South Korea
  • Taiwan
  • Thailand
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01679951 on ClinicalTrials.gov