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A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)

NCT01230827 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2016-04-04

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to methotrexate.

Conditions

  • Juvenile Idiopathic Arthritis

Interventions

DRUG

CNTO 148 (Golimumab)

Patients will receive subcutaneous (SC) (under the skin) injection of golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 248.

DRUG

Placebo

Patients who have a clinical response to golimumab at Week 16 and are randomly allocated to placebo, will receive SC injection of placebo every 4 weeks from Week 16 through Week 48.

DRUG

Methotrexate

All patients will receive their fixed dose of commercial methotrexate (10 to 30 mg per square meter) weekly throughout the study duration.

Sponsors & Collaborators

  • Schering-Plough

    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
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-09-30
Completion
2014-05-31

Countries

  • United States
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Finland
  • Germany
  • Lithuania
  • Mexico
  • Netherlands
  • Poland
  • Russia

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 NCT01230827 on ClinicalTrials.gov