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New IV drug shows promise for kids with stubborn arthritis

NCT ID NCT02277444

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an intravenous drug called golimumab in 130 children with active juvenile idiopathic arthritis that did not improve with methotrexate. The main goal was to measure how the drug moves through the body over time. The study was completed and provides information on dosing and safety for this young patient group.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

130 people

The number who actually took part.

Started

Dec 2014

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arthritis, juvenile

Contacts and locations

Locations

  • Study site

    San Diego, California, United States

  • Study site

    Chicago, Illinois, United States

  • Study site

    Boston, Massachusetts, United States

  • Study site

    Hackensack, New Jersey, United States

  • Study site

    New Hyde Park, New York, United States

  • Study site

    Durham, North Carolina, United States

  • Study site

    Hickory, North Carolina, United States

  • Study site

    Avon, Ohio, United States

  • Study site

    Cincinnati, Ohio, United States

  • Study site

    Cleveland, Ohio, United States

  • Study site

    Portland, Oregon, United States

  • Study site

    Philadelphia, Pennsylvania, United States

  • Study site

    Austin, Texas, United States

  • Study site

    Salt Lake City, Utah, United States

  • Study site

    Buenos Aires, Argentina

  • Study site

    Rosario, Argentina

  • Study site

    San Miguel de Tucumán, Argentina

  • Study site

    Botucatu, Brazil

  • Study site

    Campinas, Brazil

  • Study site

    Porto Alegre, Brazil

  • Study site

    Rio de Janeiro, Brazil

  • Study site

    São Paulo, Brazil

  • Study site

    Calgary, Alberta, Canada

  • Study site

    Toronto, Ontario, Canada

  • Study site

    Montreal, Quebec, Canada

  • Study site

    Región Metropolitana de Santia, Chile

  • Study site

    Haifa, Israel

  • Study site

    Kfar Saba, Israel

  • Study site

    Petah Tikva, Israel

  • Study site

    Chihuahua City, Mexico

  • Study site

    Guadalajara, Mexico

  • Study site

    Mexico City, Mexico

  • Study site

    Mosco2, Russia

  • Study site

    Saint Petersburg, Russia

  • Study site

    Saratov, Russia

  • Study site

    Tolyatti, Russia

  • Study site

    Ufa, Russia

  • Study site

    Cape Town, South Africa

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