Phase 2
N=31
Adalimumab (Humira) in the Treatment of Refractory Non-infectious Uveitis
Uveitis
Bottom Line
View on ClinicalTrials.gov: NCT00525902 ↗Enrolled (actual)
31
Serious AEs
3.2%
Results posted
Apr 2012
Primary outcome: Primary: Cumulative Endpoint — 21 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Adalimumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Endpoint |
12 | — |
| PRIMARY Cumulative Endpoint |
12 | — |
Summary
The purpose of this study is to assess the safety and efficacy of Adalimumab in uveitis.
Eligibility Criteria
Inclusion Criteria
- Patients with vision-threatening autoimmune uveitis.
- Failure to respond to prednisone and at least one other systemic immunosuppressive (such as methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, cyclophosphamide, or chlorambucil), or intolerance to such medications due to side effects.
Exclusion Criteria
- Serious concomitant illness that could interfere with the subject's participation in the trial.
- Previous or current use of cyclophosphamide.
- Unable or unwilling to undergo multiple injections.
Data sourced from ClinicalTrials.gov (NCT00525902). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.