Trial Outcomes & Findings for Adalimumab in JIA-associated Uveitis Stopping Trial (NCT NCT03816397)

Last Updated: 2025-05-11

Results Overview

Treatment failure is defined by recurrence of ocular inflammation in at least one eye as follows: * 3+ anterior chamber (AC) for a single visit •\>0.5+ anterior chamber (AC) cell for ≥28 days * 2-step increase in AC cell observed at two separate visits ≥7 days apart * 0.5+ vitreous haze, active retinal or choroidal inflammation, or macular edema observed at a single visit. Treatment failure can also be declared by recurrence of joint inflammation that is persistent and severe enough to necessitate unmasking to manage the arthritis recurrence. Time (days) from all participants is included in the analysis.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

87 participants

Primary outcome timeframe

From baseline until 48 weeks post-randomization

Results posted on

2025-05-11

Participant Flow

Patients were enrolled from March 3, 2020, to Feb 14, 2024, at 20 ophthalmology and rheumatology clinical sites across the United States, the United Kingdom, and Australia.

Participant milestones

Participant milestones
Measure	Continue Adalimumab Patients randomized to this arm will continue adalimumab at their current dose administered subcutaneously every other week.	Stop Adalimumab Patients randomized to this arm will receive a volume-matched placebo (0.8mL) administered subcutaneously every other week.
Overall Study STARTED	43	44
Overall Study COMPLETED	29	37
Overall Study NOT COMPLETED	14	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Continue Adalimumab Patients randomized to this arm will continue adalimumab at their current dose administered subcutaneously every other week.	Stop Adalimumab Patients randomized to this arm will receive a volume-matched placebo (0.8mL) administered subcutaneously every other week.
Overall Study Censored at interim analysis date.	13	6
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Adalimumab in JIA-associated Uveitis Stopping Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Continue Adalimumab n=43 Participants Patients randomized to this arm will continue adalimumab at their current dose administered subcutaneously every other week.	Stop Adalimumab n=44 Participants Patients randomized to this arm will receive a volume-matched placebo (0.8 mL) administered subcutaneously every other week.	Total n=87 Participants Total of all reporting groups
Age, Continuous	12.56 years n=99 Participants	12.26 years n=107 Participants	12.31 years n=206 Participants
Sex: Female, Male Female	32 Participants n=99 Participants	32 Participants n=107 Participants	64 Participants n=206 Participants
Sex: Female, Male Male	11 Participants n=99 Participants	12 Participants n=107 Participants	23 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=99 Participants	8 Participants n=107 Participants	14 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=99 Participants	28 Participants n=107 Participants	63 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants	8 Participants n=107 Participants	10 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	4 Participants n=99 Participants	3 Participants n=107 Participants	7 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) White	34 Participants n=99 Participants	33 Participants n=107 Participants	67 Participants n=206 Participants
Race (NIH/OMB) More than one race	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	4 Participants n=107 Participants	5 Participants n=206 Participants
Region of Enrollment United States	14 participants n=99 Participants	14 participants n=107 Participants	28 participants n=206 Participants
Region of Enrollment United Kingdom	27 participants n=99 Participants	27 participants n=107 Participants	54 participants n=206 Participants
Region of Enrollment Australia	2 participants n=99 Participants	3 participants n=107 Participants	5 participants n=206 Participants
Conventional DMARD Use Azathioprine	1 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants
Conventional DMARD Use Leflunomide	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Conventional DMARD Use Methotrexate (oral)	13 Participants n=99 Participants	9 Participants n=107 Participants	22 Participants n=206 Participants
Conventional DMARD Use Methotrexate (subcutaneous)	14 Participants n=99 Participants	15 Participants n=107 Participants	29 Participants n=206 Participants
Conventional DMARD Use Mycophenolate mofetil	1 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants
Conventional DMARD Use None	12 Participants n=99 Participants	13 Participants n=107 Participants	25 Participants n=206 Participants
Arthritis category None; chronic anterior uveitis	7 Participants n=99 Participants	7 Participants n=107 Participants	14 Participants n=206 Participants
Arthritis category Oligoarthritis	29 Participants n=99 Participants	29 Participants n=107 Participants	58 Participants n=206 Participants
Arthritis category Polyarthritis	7 Participants n=99 Participants	6 Participants n=107 Participants	13 Participants n=206 Participants
Arthritis category Psoriatic arthritis	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Arthritis category Undifferentiated arthritis	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Age at diagnosis of juvenile idiopathic arthritis, years	2.77 years n=99 Participants	3.71 years n=107 Participants	3.30 years n=206 Participants

PRIMARY outcome

Timeframe: From baseline until 48 weeks post-randomization

Population: Two patients dropped out of the trial before reaching the primary endpoint (one in each group). The length of time that these patients participated in the trial before dropout is included in the primary outcome analysis given the nature of survival analyses. Patients still in active follow-up who had not yet reached the primary endpoint (13 in the adalimumab group and six in the placebo group) were censored at the interim analysis date, Feb 14, 2024. No patients were lost to follow-up.

Outcome measures

Outcome measures
Measure	Continue Adalimumab n=43 Participants Patients randomized to this arm will continue adalimumab at their current weight-based dose administered subcutaneously every other week.	Stop Adalimumab n=44 Participants Patients randomized to this arm will receive a volume-matched placebo administered subcutaneously every other week.
Time to Treatment Failure	NA Time to treatment failure (days) Data are not available because a median time to treatment failure and Inter-Quartile Range (IQR) could not be calculated due to an insufficient number of participants with events.	119 Time to treatment failure (days) Interval 84.0 to 243.0

Adverse Events

Continue Adalimumab

Serious events: 4 serious events

Other events: 34 other events

Deaths: 0 deaths

Stop Adalimumab

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Continue Adalimumab n=43 participants at risk Patients randomized to this arm will continue adalimumab at their current weight-based dose, administered subcutaneously every other week.	Stop Adalimumab n=44 participants at risk Patients randomized to this arm will receive a volume-matched placebo administered subcutaneously every other week.
Surgical and medical procedures Surgery for torted cyst of Morgagni	2.3% 1/43 • Number of events 1 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	0.00% 0/44 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
Psychiatric disorders Shortness of breath at rest; suspected to be anxiety-related	2.3% 1/43 • Number of events 1 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	0.00% 0/44 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
Blood and lymphatic system disorders Over 5 times the upper limit of normal for alanine aminotransferase	2.3% 1/43 • Number of events 1 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	0.00% 0/44 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
Surgical and medical procedures Planned orthognathic surgery	2.3% 1/43 • Number of events 1 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	0.00% 0/44 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).

Other adverse events

Additional Information

Nisha Acharya, MD, MS

F.I. Proctor Foundation, University of California, San Francisco

Phone: (415) 476-6687

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Continue Adalimumab n=43 participants at risk Patients randomized to this arm will continue adalimumab at their current weight-based dose, administered subcutaneously every other week.	Stop Adalimumab n=44 participants at risk Patients randomized to this arm will receive a volume-matched placebo administered subcutaneously every other week.
Respiratory, thoracic and mediastinal disorders Allergic reaction	11.6% 5/43 • Number of events 10 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	2.3% 1/44 • Number of events 1 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
Infections and infestations COVID-19	27.9% 12/43 • Number of events 15 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	2.3% 1/44 • Number of events 1 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.3% 4/43 • Number of events 8 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	6.8% 3/44 • Number of events 4 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
Ear and labyrinth disorders Ear infection	0.00% 0/43 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	4.5% 2/44 • Number of events 2 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
General disorders Fatigue	34.9% 15/43 • Number of events 28 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	18.2% 8/44 • Number of events 12 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
Infections and infestations Fever	18.6% 8/43 • Number of events 8 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	4.5% 2/44 • Number of events 2 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
Infections and infestations Influenza	7.0% 3/43 • Number of events 3 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	2.3% 1/44 • Number of events 1 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
General disorders Headache	39.5% 17/43 • Number of events 24 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	22.7% 10/44 • Number of events 20 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
Gastrointestinal disorders Gastrointestinal related	55.8% 24/43 • Number of events 51 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	38.6% 17/44 • Number of events 19 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
Psychiatric disorders Mood changes	14.0% 6/43 • Number of events 7 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	6.8% 3/44 • Number of events 4 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
Musculoskeletal and connective tissue disorders Muscle weakness	9.3% 4/43 • Number of events 4 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	2.3% 1/44 • Number of events 2 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
Nervous system disorders Impaired neurological function	2.3% 1/43 • Number of events 1 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	2.3% 1/44 • Number of events 1 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
Infections and infestations Pneumonia	0.00% 0/43 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	2.3% 1/44 • Number of events 1 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
Respiratory, thoracic and mediastinal disorders Sinus infection	2.3% 1/43 • Number of events 2 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	2.3% 1/44 • Number of events 1 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
Infections and infestations Skin infection	9.3% 4/43 • Number of events 5 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	6.8% 3/44 • Number of events 4 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
Infections and infestations Upper respiratory infection	20.9% 9/43 • Number of events 16 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	15.9% 7/44 • Number of events 8 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
Infections and infestations Other infection‡‡	9.3% 4/43 • Number of events 5 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	9.1% 4/44 • Number of events 5 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
Blood and lymphatic system disorders Atypical haemoglobin	0.00% 0/43 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	2.3% 1/44 • Number of events 1 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
Blood and lymphatic system disorders Atypical leukocyte count	0.00% 0/43 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	4.5% 2/44 • Number of events 2 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
Blood and lymphatic system disorders Atypical aspartate aminotransferase or alanine aminotransferase	4.7% 2/43 • Number of events 3 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	0.00% 0/44 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
Eye disorders Ocular hypertension	2.3% 1/43 • Number of events 1 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	4.5% 2/44 • Number of events 4 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
Eye disorders Other ocular event	9.3% 4/43 • Number of events 4 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	9.1% 4/44 • Number of events 4 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).
General disorders Other events	32.6% 14/43 • Number of events 31 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).	20.5% 9/44 • Number of events 16 • Adverse events shown were reported before or at the primary endpoint (treatment failure or censoring at 48 weeks).