Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial (ADJUST)

Phase 1

• Conditions: juvenile-idiopathic arthritispaediatric uveitis; MedDRA version: 20.0Level: LLTClassification code 10022557Term: Intermediate uveitisSystem Organ Class: 100000004853; MedDRA version: 20.0Level: LLTClassification code 10033687Term: PanuveitisSystem Organ Class: 100000004853; MedDRA version: 20.1Level: LLTClassification code 10036370Term: Posterior uveitisSystem Organ Class: 100000004862; MedDRA version: 20.1Level: LLTClassification code 10066681Term: Acute uveitisSystem Organ Class: 100000004853; MedDRA version: 20.0Level: PTClassification code 10059176Term: Juvenile idiopathic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2019-000412-29-GB
• Lead Sponsor: F.I. Proctor Foundation, University of California San Francisco

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-25
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

Stated willingness to comply with all study procedures and availability for the duration of the study period
History of JIA diagnosed prior to 16 years of age
2 year of age or older
Formal diagnosis of JIA-associated uveitis with no other suspected etiology
=12 consecutive months of controlled ocular inflammation (=0.5+ AC cell, =0.5+ vitreous haze, and no active retinal/choroidal lesions in either eye or macular edema)
= 12 consecutive months of controlled arthritis verified by a pediatric rheumatologist (see definition of controlled arthritis in Table 2)
=12 consecutive months with adalimumab or a biosimilar
=180 days on a stable dose of adalimumab or a biosimilar; must be a biweekly dose of no greater than 20 mg (if< 30kg) or 40 mg (if =30kg)
If on a biosimilar of adalimumab, =90 days on biosimilar
If on concomitant injectable or oral methotrexate or mycophenolate mofetil, dose must be =25 mg weekly for methotrexate or =3 g daily for mycophenolate mofetil and stable for =90 days
If on topical corticosteroids, dose must be =2 drops prednisolone acetate 1% or equivalent per day and stable for =90 days
Willingness to limit consumption of alcohol during the study period
Agreement to avoid live attenuated vaccinations
Agreement to use effective contraception or abstinence for =28 days prior to screening and throughout study period (for patients of reproductive age)

Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Intraocular surgery in the past 90 days or planned surgery in the next 180 days
Severe cataract or opacity preventing view to the posterior pole in both eyes
Acute or recurrent anterior uveitis characterized by redness and symptoms, including but not limited to: floaters, light sensitivity, pain
Chronic hypotony (< 5 mmHg for =90 days) in either eye
Treatment with oral corticosteroids or intraocular corticosteroid injections within the last 12 months
Acute anterior uveitis characterized by redness and symptoms, including but not limited to floaters, pain, and light sensitivity
Pregnancy or lactation (a pregnancy test will be conducted at baseline and all follow-up visits for females of reproductive age)
Prior safety or tolerability issues with adalimumab
History of cancer, tuberculosis, or hepatitis B
Other medical condition expected to dictate treatment course during the study
Any of the following abnormal lab values within 28 days prior to enrollment: leukocyte count < 2500, platelet count =75000, hemoglobin< 9.0, AST (SGOT) or ALT (SGPT) = 2 times the upper limit of normal range, creatinine =1.5

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified