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A Study of Effectiveness and Safety of CNTO 136 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

NCT00718718 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2018-01-23

Study results available
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Summary

The purpose of this study is to evaluate the effectiveness and safety of subcutaneous (under the skin) administration of anti-interleukin-6 monoclonal antibody (CNTO 136) in reducing signs and symptoms of participants with active rheumatoid arthritis (RA) with methotrexate (MTX) therapy.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

CNTO 136 100 mg

CNTO 136 100 mg will be administered subcutaneously (under the skin) every 2 or 4 weeks as per the appropriate randomized arm.

DRUG

CNTO 136 50 mg

CNTO 136 50 mg will be administered subcutaneously every 4 weeks from Week 0 to Week 24.

DRUG

CNTO 136 25 mg

CNTO 136 25 mg will be administered subcutaneously every 4 weeks from Week 0 to Week 24.

DRUG

Placebo

Placebo will be adminstered subcutaneously as per the appropriate randomized arm.

DRUG

Methotrexate

Stable dose of methotrexate will be maintained through Week 24.

Sponsors & Collaborators

  • Centocor, Inc.

    lead INDUSTRY

Principal Investigators

  • Centocor Clinical Trial · Centocor, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-11
Primary Completion
2011-03-03
Completion
2011-03-03
FDA Drug
Yes

Countries

  • United States
  • Hungary
  • Japan
  • Mexico
  • Poland
  • Russia
  • South Korea

Study Locations

More Related Trials

Entities

Drugs

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 NCT00718718 on ClinicalTrials.gov