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A Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy (SIRROUND-T)

NCT01606761 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 878

Last updated 2018-03-23

Study results available
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Summary

The purpose of this study is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of rheumatoid arthritis (RA) in patients with active RA who are unresponsive or intolerant to treatment with anti-TNF-alpha agents.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

Placebo

Form=solution for injection, route=subcutaneous use; every 2 weeks from Week 0 through Week 22.

DRUG

Placebo

Form=solution for injection, route=subcutaneous use; Weeks 2, 6, and every 4 weeks through Week 52.

DRUG

Sirukumab

Type=exact, unit=mg, number=50 or 100, form=solution for injection, route=subcutaneous use; every 2 weeks for 100 mg and every 4 weeks for 50 mg, Week 23 through Week 52.

DRUG

Sirukumab

Type=exact, unit=mg, number=100, form=solution for injection, route=subcutaneous use; Weeks 0, 2, and every 2 weeks through Week 52.

DRUG

Sirukumab

Type=exact, unit=mg, number=50, form=solution for injection, route=subcutaneous use; Weeks 0, 4, and every 4 weeks through Week 52.

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
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-06
Primary Completion
2015-03-17
Completion
2016-01-12
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Canada
  • Croatia
  • France
  • Germany
  • Japan
  • Lithuania
  • Mexico
  • Netherlands
  • New Zealand
  • Poland
  • Portugal
  • Puerto Rico
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

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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 NCT01606761 on ClinicalTrials.gov