Drug shows promise for kids with Arthritis-Related eye disease
NCT ID NCT01385826
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested the drug adalimumab against a placebo in 34 children with juvenile arthritis and active eye inflammation (uveitis) that wasn't controlled by steroid drops or methotrexate. The goal was to see if adalimumab could reduce eye inflammation after two months. After that, all participants could receive adalimumab for up to a year to track safety and long-term effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- adalimumab (a drug that blocks inflammation)
- What this could lead to
- If it works, this could provide a treatment option for children with arthritis-related eye inflammation that hasn't responded to standard therapies.
- What could go wrong
- This is a small, early-phase trial with only 34 participants. The results may not apply to all children, and long-term safety and effectiveness are still being studied.
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 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
-
34 people
The number who actually took part.
- Started
-
Jun 2011
- Finished
-
Aug 2015
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 Hide 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: 1. Active uveitis associated with juvenile idiopathic arthritis, with the exclusion of systemic JIA, juvenile-onset rheumatoid arthritis, and enthesitis-related JIA 2. Uveitis resistant to well conducted topical steroid therapy comprising either dexamethasone or rimexolone at a dose adapted to the patient's situation as validated by one of the investigating ophthalmologists. 3. Failure of systemic treatment with methotrexate at a dose of 0.3 to 0.6 mg.kg (without exceeding 25 mg) once a week for at least 3 months (except in the case of methotrexate intolerance). 4. Patient who can be evaluated by laser flare photometry. 5. Patient at least 4 years old on initiation of trial medication and weighing a minimum of 15 kg 6. Signed informed consent both parents and/or patient's agreement 7. Patient has a social security or similar Exclusion Criteria: 1. Systemic JIA, juvenile-onset rheumatoid arthritis, enthesitis-related JIA (with a risk of red eye uveitis). 2. History of treatment with anti-TNF alpha monoclonal antibody (either adalimumab or infliximab). 3. Any contraindication to administration of immunosuppressive therapy (immune deficit, opportunistic infection, other severe chronic disease) * History of cancer or lymphoproliferative disease other than successfully and completely resected squamous cell or basal cell skin cancer, * Any uncontrolled disease: unstable diabetes with documented history of recurrent infections, unstable ischaemic heart disease, moderate to severe heart failure (NYHA stage III/IV), recent stroke and any other disease or condition inducing, in the investigator's opinion, a risk for the patient related to his/her participation in the trial, * Positive hepatitis B or C serology indicating active infection, * History of positive HIV serology, * Persistent infection or severe infections requiring hospitalisation or IV antibiotic therapy during the 30 days prior to inclusion in the trial or oral antibiotic therapy during the 14 days prior to inclusion in the trial, * History of clinically significant alcohol or other substance abuse during the previous year, * Previous diagnosis or signs of demyelinating disease of the central nervous system, * History of active tuberculosis, histoplasmosis or listeriosis, * Signs of latent tuberculosis (based on a history of nontreated contamination, or an opacity greater than 1 cm on chest x-ray, or a positive intradermal reaction to 5 IU of tuberculin ≥ 5 mm). * Negative urine pregnancy test in girls with childbearing potential 4. Chronic rupture of the blood-aqueous barrier with marked flare on the initial examination but not modified by one month of anti-inflammatory therapy. 5. Impossibility to monitor flare: * Children \< 4 years * False flare due to the presence of giant cells on the surface of an artificial lens or in an aphakic child. 6. Children presenting complications such as refractory glaucoma or cataract rapidly requiring surgery. 7. Phthisis bulbi with hypotonia and atrophy of the ciliary body. 8. Any other situation raising problems for maintenance of stable doses of steroids and immunosuppressive drugs during the period between 4 weeks before D0 and the M2 evaluation. Authorized immunosuppressive therapies that must be maintained at stable dose are steroid eye drops, systemic steroid therapy and once weekly oral or subcutaneous MTX at a dose of 0.3 to 0.6 mg (without exceeding 25 mg). 9. Any ophthalmologic contraindication 10. If female and childbearing potential should have an appropriate contraceptive method during all study period and 5 months after last adalimumab dose. Abstinence with no oral contraception can be considered.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hospital of necker Enfants malades
Paris, 75015, France
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