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Arthritis drug tested for Long-Term safety in kids

NCT ID NCT01673919

Disease control Sponsor: Hoffmann-La Roche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looked at the long-term safety of the drug tocilizumab (Actemra) in 7 children with a type of arthritis called juvenile idiopathic arthritis. All children had already completed a previous study and continued to receive the drug every 4 weeks for up to 2 years. The main goal was to track any side effects or serious health issues.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tocilizumab (brand name Actemra/RoActemra)
What this could lead to
If successful, this could confirm that long-term use of tocilizumab is safe for managing juvenile idiopathic arthritis in children.
What could go wrong
This is a very small extension study (7 people) with no comparison group, so results may not apply broadly. Side effects like infections are possible.

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

7 people

The number who actually took part.

Start date

Feb 2012

Finished

Jan 2014

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

4 years and older

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: * Patients who completed visit 33 (week 104) of WA19977 study and who may benefit from study drug treatment according to the investigator's assessment * Patients have to receive the first RoActemra/Actemra infusion in this study at the Week 8 visit at the latest * Females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol Exclusion Criteria: * Patients with, according to investigator judgment, not satisfactory benefit from RoActemra/Actemra therapy within WA19977 * Treatment with any investigational agent since the last administration of study drug in the core study WA19977 * Patient developed any other autoimmune rheumatic disease or overlap syndrome other than the permitted polyarticular-course Juvenile Idiopathic Arthritis (JIA) subsets: rheumatoid factor positive or negative JIA or extended oligoarticular JIA * Patient is pregnant , lactating, or intending to become pregnant during the study and up to 12 weeks after the last administration of study drug * Any significant concomitant disease or medical or surgical condition * History of significant allergic or infusion reactions to prior biologic therapy * Currently active primary or secondary immunodeficiency * Any infections with contraindications to RoActemra/Actemra therapy according to investigator judgment * Inadequate hepatic, renal or bone marrow function

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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.

Juvenile idiopathic arthritis

Contacts and locations

Locations

  • Study site

    Le Kremlin-Bicêtre, 94275, France

  • Study site

    Montpellier, 34295, France

  • Study site

    Paris, 75679, France

  • Study site

    Paris, 75743, France

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