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)

Last updated: March 31, 2016
Sponsor: Janssen Research & Development, LLC
Overall Status: Terminated

Phase

3

Condition

Joint Injuries

Rheumatoid Arthritis (Pediatric)

Arthritis And Arthritic Pain (Pediatric)

Treatment

N/A

Clinical Study ID

NCT01230827
CR017089
CNTO148JIA3001
2009-015019-42
  • Ages 2-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis must have been before the patient's 16th birthday

  • Disease duration of at least 6 months before study entry

  • Must have 5 or more joints with active arthritis

  • Must be taking a stable dose of methotrexate 10-30 mg/meter squared (patients withbody surface area [BSA] 1.67 square meter or more must be taking a minimum of 15mg/week of methotrexate)

  • May take a stable dose of prednisone less than 10 mg/day 4 weeks prior to entry or maytake a stable dose of NSAIDS (non-steroidal anti-inflammatory drugs) 2 weeks prior toentry

  • Must have qualifying laboratory values at the first visit.

Exclusion

Exclusion Criteria:

  • Have known allergies, hypersensitivity, or intolerance to golimumab or similartherapeutics

  • Are pregnant or breast-feeding, or planning a pregnancy or fathering a child within 6months after the last study agent administration

  • Have initiated DMARDS and/or immunosuppressive therapy within 4 weeks prior to studyinitiation

Study Design

Total Participants: 173
Study Start date:
December 01, 2010
Estimated Completion Date:
May 31, 2014

Study Description

Approximately 170 juvenile patients will take part in the study worldwide. All patients will receive 30mg/m2 (milligrams per meter squared, up to 50 mg per dose) of golimumab subcutaneously (injection under the skin) every 4 weeks from Week 0 through Week 12. At Week 16, patients who have shown at least a 30 percent improvement in their signs and symptoms from when they started the study will be randomized to receive either placebo (sham medicine injection) or 30 mg/m2 of golimumab injections every 4 weeks from week 16 through week 48. If a patient gets markedly worse and is receiving placebo injections, they will be restarted on golimumab at the next scheduled visit and will continue on golimumab. Patients can leave the study at any time without question. Between the Week 48 analyses timepoint to Week 144, which is subsequently amended to Week 248, all patients will receive golimumab 30mg/meter squared, unless, by measurements, they have been nearly cured (clinical remission) by being on placebo, whereby they will be discontinued from the study. Patients may have a change in background treatment after Week 48 based on therapeutic effect. Patients will continue active treatment after Week 48 in a long-term extension until Week 144, which is subsequently amended to Week 248. All patients will receive their fixed dose of commercial methotrexate throughout the study duration. Safety will be monitored up to 152 week, which is subsequently amended to 256 weeks including drawing blood and looking at laboratory tests, vital signs (eg, blood pressure), and the frequency and type of adverse events (side effects).

Connect with a study center

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    Buenos Aires,
    Argentina

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    Córdoba,
    Argentina

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    Córdoba,
    Argentina

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    La Plata,
    Argentina

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    Rosario,
    Argentina

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  • Bregenz,
    Austria

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  • Wien,
    Austria

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  • Brussels,
    Belgium

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  • Gent,
    Belgium

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  • Leuven,
    Belgium

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  • Botucatu,
    Brazil

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  • Curitiba,
    Brazil

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    Ribeirão Preto,
    Brazil

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  • Ribeirão Preto,
    Brazil

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  • Rio De Janeiro,
    Brazil

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  • Halifax, Nova Scotia
    Canada

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    Ottawa, Ontario
    Canada

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  • Toronto, Ontario
    Canada

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    Montreal, Quebec
    Canada

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  • Helsinki,
    Finland

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  • Oulu,
    Finland

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  • Bad Bramstedt,
    Germany

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  • Berlin,
    Germany

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  • Bremen,
    Germany

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  • Hamburg,
    Germany

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  • Sankt Augustin,
    Germany

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  • Vilnius,
    Lithuania

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  • Ciudad De Mexico,
    Mexico

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  • Monterrey,
    Mexico

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  • San Luis Potosi,
    Mexico

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    Amsterdam,
    Netherlands

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  • Utrecht,
    Netherlands

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  • Krakow,
    Poland

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  • Lodz,
    Poland

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    Warszawa,
    Poland

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  • Moscow,
    Russian Federation

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  • Saint-Petersburg,
    Russian Federation

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  • Samara,
    Russian Federation

    Site Not Available

  • Los Angeles, California
    United States

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  • San Francisco, California
    United States

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  • Augusta, Georgia
    United States

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    Louisville, Kentucky
    United States

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  • Boston, Massachusetts
    United States

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  • Durham, North Carolina
    United States

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  • Cincinatti, Ohio
    United States

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  • Portland, Oregon
    United States

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    Salt Lake City, Utah
    United States

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