A Multicenter, Open-Label Trial of Intravenous Golimumab, a Human Anti-TNFα Antibody, in Pediatric Subjects With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy

ClinicalTrials.gov processed this data on August 13, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

ACTIVE, NOT RECRUITING - HAS RESULTS
 (See Contacts and Locations)
Verified August 2024 by Janssen Research & Development, LLC

Sponsor

Janssen Research & Development, LLC

Information Provided by (Responsible Party)

Janssen Research & Development, LLC

Clinicaltrials.gov Identifier

NCT02277444
Other Study ID Numbers: CR105178
First Submitted: October 27, 2014
First Posted: October 29, 2014
Results First Posted: November 18, 2020
Last Update Posted: August 15, 2024
Last Verified: August 2024
History of Changes

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Study Description

This is a single arm, Open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study) study to determine the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), efficacy (effectiveness) and safety of intravenous golimumab in participants with pJIA despite current treatment with methotrexate (MTX). The study will consist of 3 parts: Screening Phase (6 weeks); an Open-label Treatment Phase (consists of golimumab and MTX treatment for 52 weeks, wherein after Week 28, MTX dose change is allowed); Long-term Extension Phase (after Week 52 through Week 252) and Extended Treatment Period (after week 252). The maximal study duration for a participant will not exceed 832 weeks. All the eligible participants will be administered golimumab IV infusion and commercial MTX. Blood samples will be collected for evaluation of pharmacokinetics of study treatment. Participants' safety will be monitored throughout the study.
Condition or Disease Intervention/Treatment
  • Arthritis, Juvenile
  • Drug: Golimumab
  • Drug: Methotrexate

Study Design

Study TypeInterventional
Actual Enrollment130 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Multicenter, Open-Label Trial of Intravenous Golimumab, a Human Anti-TNFα Antibody, in Pediatric Subjects With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy
Study Start DateDecember 2014
Actual Primary Completion DateJuly 2018
Anticipated Study Completion DateNovember 2028

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • Golimumab + Methotrexate
    • Participants will receive 80 milligram per meter square (mg/m^2) as an intravenous (IV) infusion at Weeks 0, 4, and every 8 weeks thereafter up to Week 244, along with commercial methotrexate (MTX) weekly through Week 28 at the same Body Surface Area (BSA)-based dosage (10 to 30 mg/m^2 per week for participants with BSA less than [<] 1.67 meter square (m^2), or minimum of 15 mg/week for participants with BSA greater than or equal to [>=] 1.67 m^2) as at the time of study entry. At Week 252, participants who meet the criteria for the optional Extended Treatment Period (ETP) may continue treatment with golimumab 80 mg/m^2 every 8 weeks after completion of the Week 252 assessments.
  • Drug: Golimumab
    • Golimumab 80 mg/m^2 IV infusion at Weeks 0, 4, and every 8 weeks through Week 244. At Week 252, participants who meet the criteria for the optional Extended Treatment Period (ETP) may continue treatment with golimumab 80 mg/m^2 every 8 weeks after completion of the Week 252 assessments.
  • Drug: Methotrexate

    Outcome Measures

    Primary Outcome Measures

    1. Serum Trough Concentration (C-trough) of Golimumab [Week 28]
      Serum golimumab trough concentration at Week 28 was reported.
    2. Bayesian Area Under Curve at Steady State (AUCss) Over an 8-week Dosing Interval at Week 28 [Week 28]
      AUCss was defined as area under the plasma concentration-time curve at steady-state (based on steady-state assessment of trough concentrations or via modeling).

    Secondary Outcome Measures

    1. Serum Trough Concentration (C-trough) at Week 52 [Week 52]
      Serum golimumab trough concentration at Week 52 was reported.
    2. Baysesian Area Under Curve at Steady State (AUCss) at Week 52 [Week 52]
      AUCss was defined as area under the plasma concentration-time curve at steady-state (based on steady-state assessment of trough concentrations or via modeling).

    Eligibility Criteria

    Ages Eligible for Study 2 Years to 17 Years (Child)
    Sexes Eligible for Study All
    Accepts Healthy Volunteers No
    Inclusion Criteria
    • Diagnosis must be made per Juvenile Idiopathic Arthritis (JIA) International League of Associations for Rheumatology (ILAR) diagnostic criteria and the onset of disease must have been before the participant's 16th birthday
    • Failure or inadequate response to at least a 2 month course of methotrexate (MTX) before screening
    • Participants must have greater than or equal to (>=) 5 joints with active arthritis at screening and at Week 0 as defined by American College of Rheumatology (ACR) criteria (that is, a joint with either swelling, or in the absence of swelling, limited range of motion associated with pain on motion or tenderness)
    • Participants must have a screening C-reactive protein (CRP) of >=0.1 milligram (mg)/deciliter (dL) with the exception of approximately 30 percent (%) of the study population
    • Participants must have active polyarticular juvenile idiopathic arthritis (pJIA) despite current use of oral, intramuscular, or subcutaneous MTX for >=2 months before screening. For participants with body surface area (BSA) less than (<)1.67 meter square (m^2), the MTX dose must be between 10 to 30 milligram per meter square (mg/m^2) per week and stable for >=4 weeks before screening. For participants with BSA >=1.67 m^2, the MTX dose must be a minimum of 15 mg/week and must be stable for >=4 weeks before screening. In situations where there is documented intolerance of doses greater than (>)10 mg/m^2 weekly (for participants with BSA <1.67 m^2) or >=15 mg/week (for participants with BSA >=1.67 m^2); or where documented country or site regulations prohibit use of >=15 mg of MTX per week in participants with BSA >=1.67 m^2, participants may be entered into the trial on a lower dose of MTX
    Exclusion Criteria
    • Participant has initiated disease-modifying antirheumatic drugs (DMARDs) and/or immunosuppressive therapy within 4 weeks prior to first study agent administration
    • Participant has been treated with intra-articular, intramuscular or intravenous corticosteroids (including intramuscular corticotropin) during the 4 weeks before first study agent administration
    • Participant has been treated with any therapeutic agent targeted at reducing Interleukin (IL)-12 or IL 23, including but not limited to ustekinumab and ABT-874, within 3 months before first study agent administration
    • Participant has been treated with natalizumab, efalizumab, or therapeutic agents that deplete B or T cells (eg, rituximab, alemtuzumab, or visilizumab) during the 12 months before first study agent administration, or have evidence at screening of persistent depletion of the targeted lymphocyte after receiving any of these agents
    • Participant has been treated with alefacept within 3 months before first study agent administration
    • If a participant has been previously treated with an anti-tumor necrosis factor alpha (TNF alpha) agent, the reason for discontinuation of the anti-TNF alpha agent cannot have been a severe or serious adverse event consistent with the class of anti-TNF alpha agents

    Contacts and Locations

    Sponsors and Collaborators Janssen Research & Development, LLC
    Locations
    • | San Diego, California, United States,
    • | Chicago, Illinois, United States,
    • | Boston, Massachusetts, United States,
    • | Hackensack, New Jersey, United States,
    • | New Hyde Park, New York, United States,
    • | Durham, North Carolina, United States,
    • | Hickory, North Carolina, United States,
    • | Avon, Ohio, United States,
    • | Cincinnati, Ohio, United States,
    • | Cleveland, Ohio, United States,
    • | Portland, Oregon, United States,
    • | Philadelphia, Pennsylvania, United States,
    • | Austin, Texas, United States,
    • | Salt Lake City, Utah, United States,
    • | Buenos Aires, Argentina,
    • | Rosario, Argentina,
    • | San Miguel De Tucuman, Argentina,
    • | Botucatu, Brazil,
    • | Campinas, Brazil,
    • | Porto Alegre, Brazil,
    • | Rio de Janeiro, Brazil,
    • | Sao Paulo, Brazil,
    • | Calgary, Alberta, Canada,
    • | Toronto, Ontario, Canada,
    • | Montreal, Quebec, Canada,
    • | Región Metropolitana De Santia, Chile,
    • | Haifa, Israel,
    • | Kfar-Saba, Israel,
    • | Petach-Tikva, Israel,
    • | Chihuahua, Mexico,
    • | Ciudad De Mexico, Mexico,
    • | Guadalajara, Mexico,
    • | Mosco2, Russian Federation,
    • | Saint Petersburg, Russian Federation,
    • | Saratov, Russian Federation,
    • | Togliatti, Russian Federation,
    • | Ufa, Russian Federation,
    • | Cape Town, South Africa,
    Investigators

      Study Documents (Full Text)