Trial Outcomes & Findings for Adalimumab (Humira) in the Treatment of Refractory Non-infectious Uveitis (NCT NCT00525902)

NCT ID: NCT00525902

Last Updated: 2012-04-11

Results Overview

Improvement in at least one of these criteria without significant worsening in any of them. 1) improvement by 2 or more lines of best-corrected Snellen visual acuity in at least one eye; (2) reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50%; (3) two-step improvement in control of ocular inflammation; and (4) reduction of cystoid macular edema and other inflammatory signs on angiography.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 31 participants
• Primary outcome timeframe: 10 weeks
• Results posted on: 2012-04-11

Participant Flow

Participant milestones

Measure	Adalimumab
Overall Study STARTED	31
Overall Study 10 Weeks	30
Overall Study 50 Weeks	12
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Adalimumab
Overall Study Lack of Efficacy	1

Baseline Characteristics

Adalimumab (Humira) in the Treatment of Refractory Non-infectious Uveitis

Baseline characteristics by cohort

Measure	Adalimumab n=31 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age Continuous	40.9 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 weeks

Improvement in at least one of these criteria without significant worsening in any of them. 1) improvement by 2 or more lines of best-corrected Snellen visual acuity in at least one eye; (2) reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50%; (3) two-step improvement in control of ocular inflammation; and (4) reduction of cystoid macular edema and other inflammatory signs on angiography.

Outcome measures

Measure	Adalimumab n=31 Participants
Cumulative Endpoint	21 participants

PRIMARY outcome

Timeframe: 50 Weeks

Population: Participants characterized as clinical responders at 10 weeks were allowed to continue in the study.

Improvement in at least one of these criteria without significant worsening in any of them. 1) improvement by 2 or more lines of best-corrected Snellen visual acuity in at least one eye; (2) reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50%; (3) two-step improvement in control of ocular inflammation; and (4) reduction of cystoid macular edema and other inflammatory signs on angiography.

Outcome measures

Measure	Adalimumab n=21 Participants
Cumulative Endpoint	12 participants

Adverse Events

Adalimumab

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Adalimumab n=31 participants at risk
Blood and lymphatic system disorders Hypoglycemic Coma	3.2% 1/31 • Number of events 1
Vascular disorders Stroke	3.2% 1/31 • Number of events 1

Other adverse events

Measure	Adalimumab n=31 participants at risk
General disorders Headache	9.7% 3/31 • Number of events 3
General disorders Joint pain	9.7% 3/31 • Number of events 3

Additional Information

Eric B. Suhler

Oregon Health & Science University

Phone: 503-494-5023

Email: suhlere@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place