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A Study Comparing Sirukumab (CNTO 136) Monotherapy With Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis

NCT02019472 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 559

Last updated 2017-10-26

Study results available
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Summary

The primary objective is to investigate the efficacy of sirukumab monotherapy compared with adalimumab monotherapy in biologic naïve subjects with active rheumatoid arthritis who are intolerant to methotrexate, who are considered inappropriate for treatment with methotrexate or who are inadequate responders to methotrexate.

Conditions

  • Arthritis, Rheumatoid

Interventions

BIOLOGICAL

adalimumab 40 mg

SC injections

BIOLOGICAL

sirukumab 100 mg

SC injections

BIOLOGICAL

sirukumab 50 mg

SC injections

DRUG

Placebo

SC injections

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • 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
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-04
Primary Completion
2016-08-17
Completion
2016-08-17

Countries

  • United States
  • Bulgaria
  • Chile
  • Colombia
  • Germany
  • Hungary
  • Lithuania
  • Mexico
  • Moldova
  • Poland
  • Romania
  • Russia
  • Serbia
  • South Africa
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT02019472 on ClinicalTrials.gov