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Effect of Adalimumab for the Treatment of Uveitis in Juvenile Idiopathic Arthritis

NCT01385826 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-09-08

No results posted yet for this study

Summary

The investigators propose to study the efficacy of adalimumab versus placebo (double-blind randomization on inclusion into 2 equal groups) on reduction of ocular inflammation quantified by laser flare photometry after two months of treatment in patients with active uveitis despite well conducted treatment with steroid eye drops and MTX. The primary objective is to demonstrate a higher response rate at 2 months in the adalimumab arm versus the placebo arm. Will be considered as responding patients those in whom the evaluated eye, 2 months after inclusion, presents at least 30% reduction of inflammation on laser flare photometry and improvement or a stable appearance on slit lamp examination. After the second month, all patients wishing to continue the trial and presenting a satisfactory clinical state will be treated with adalimumab for a total of one year after inclusion to descriptively evaluate the efficacy and safety of treatment over 10 to 12 months.

Conditions

  • Uveitis
  • Juvenile Arthritis

Interventions

DRUG

Anti-tumor necrosis factor alpha monoclonal antibody

The dose of adalimumab will be 40 mg for children age 13 and over and for children younger than 13 adalimumab 24 mg per m2 BSA (up to a maximum total body dose of 40 mg).

DRUG

placebo

Patients will receive 4 injections of placebo on D0, D14, D28, and D42 with assessment of the primary endpoint at M2

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Pierre Quartier dit Maire, MD, PhD · hospital Necker Enfants Malades

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-29
Primary Completion
2014-11-04
Completion
2015-08-27

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01385826 on ClinicalTrials.gov