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An Efficacy And Safety Study of CNTO 6785 In Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy

NCT01909427 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2016-03-02

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy and safety of CNTO6785 in participants with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.

Conditions

Interventions

DRUG

Placebo

Placebo subcutaneous injections (SC) every 4 weeks through Week 12

DRUG

CNTO 6785 200 mg

CNTO 6785 200 mg SC every 4 weeks from Week 16 through Week 28

DRUG

CNTO 6785 200 mg

CNTO 6785 200 mg SC every 4 weeks through Week 28

DRUG

CNTO 6785 100 mg

CNTO 6785 100 mg SC every 4 weeks through Week 28

DRUG

CNTO 6785 50 mg

CNTO 6785 50 mg SC every 4 weeks through Week 28

DRUG

CNTO 6785 15 mg

CNTO 6785 15 mg SC every 4 weeks through Week 28

DRUG

Methotrexate (MTX)

MTX at the same stable dose through Week 32, that participants were receiving prior to screening.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-12-31
Completion
2015-05-31

Countries

  • Argentina
  • Colombia
  • Czechia
  • Philippines
  • Poland
  • Russia
  • Thailand

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 NCT01909427 on ClinicalTrials.gov