Adalimumab Levels in Induction Control for Chronic Anterior Uveitis
S
Stacey Tarvin, MD
Primary Investigator
Enrolling By Invitation
17 years or below
All
Phase
N/A
7 participants needed
1 Location
Brief description of study
What is this study about?
The purpose of this study is to understand whether blood levels of adalimumab (brand name: Humira) can be used to predict how well uveitis will respond to adalimumab.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Eligible uveitis participants will be identified at each center by participating ophthalmologists and rheumatologists who will alert the research team of patients beginning treatment with adalimumab for CAU. The study team will review medical records for eligibility. Eligible participants will be approached during clinic visits to the rheumatology or ophthalmology clinics, or by telephone, between month 0 to <2 months, by members of the study team (either site specific research associate/coordinator and/or physician) to assess interest for participating in the study. If interested, electronic informed consent, via REDCap, or paper consent will be obtained from eligible participants at or before the beginning of the first study visit.
Detailed description of study
What happens during study participation?
Study participation will last for 6 months and will involve 3 study visits with blood draws.
There are differences between this study and the participant's usual care.
In addition to routine clinical assessment and taking prescribed adalimumab, participants will be asked to:
- Have research blood tests (at months 2, 4, and 6 after starting to take adalimumab as part of clinical care).
- Complete research questionnaires.
- Ensure that they have eye exams at 2, 4, and 6 months after starting adalimumab as part of clinical care.
- Have medical records reviewed for research purposes.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Chronic anterior uveitis, Riley
-
Age: 17 years or below
-
Gender: All
Inclusion criteria:
1) Chronic anterior uveitis.
2) Age <18 years at onset.
3) Active uveitis at start of ADA (month 0): >0.5+ anterior chamber (AC) cell or ≤ 0.5+ AC cell on >2 drops per day of topical steroid.
4) Initiation of adalimumab (ADA) for active uveitis (10 to <15 kg: 10 mg; 15 to <30 kg: 20 mg; ≥30 kg: 40 mg). Alternate week or weekly dosing is allowed. Starting dose or frequency per treating physician discretion may exceed standard weight-based dosing. Concomitant methotrexate treatment is allowed.
5) Availability of clinic ophthalmology exam with uveitis disease activity information from at start of ADA (see variables in 4.2.1)
6) Previous treatment with another TNFi (not ADA) is allowed.
7) Proficient in English.
2) Age <18 years at onset.
3) Active uveitis at start of ADA (month 0): >0.5+ anterior chamber (AC) cell or ≤ 0.5+ AC cell on >2 drops per day of topical steroid.
4) Initiation of adalimumab (ADA) for active uveitis (10 to <15 kg: 10 mg; 15 to <30 kg: 20 mg; ≥30 kg: 40 mg). Alternate week or weekly dosing is allowed. Starting dose or frequency per treating physician discretion may exceed standard weight-based dosing. Concomitant methotrexate treatment is allowed.
5) Availability of clinic ophthalmology exam with uveitis disease activity information from at start of ADA (see variables in 4.2.1)
6) Previous treatment with another TNFi (not ADA) is allowed.
7) Proficient in English.
Updated on
29 Apr 2025.
Study ID: PRHU-CHOP-ADA-LEVELS, 17115
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