Trial Outcomes & Findings for Multi Center Prospective Registry of Infliximab Use for Childhood Uveitis (NCT NCT00589628)

NCT ID: NCT00589628

Last Updated: 2013-08-26

Results Overview

Number of subjects with improvement in uveitis, defined as a two step decrease in level of inflammation (as defined by SUN criteria, AC cells, vitreous haze) or decrease to grade 0. A grading scheme of 0 indicating (\<1 cell/ocular field) low levels of inflammation to 4+ indicating (\>50 cells/ocular field) indicating high levels of inflammation.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 13 participants
• Primary outcome timeframe: 9 months
• Results posted on: 2013-08-26

Participant Flow

Participant milestones

Measure	Infliximab 5 mg/kg 5mg/kg/does of infliximab IV at 4 week intervals	Infliximab 10 mg/kg 10mg/kg/dose of infliximab Iv at 4 week intervals
Overall Study STARTED	7	6
Overall Study COMPLETED	7	5
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Infliximab 5 mg/kg 5mg/kg/does of infliximab IV at 4 week intervals	Infliximab 10 mg/kg 10mg/kg/dose of infliximab Iv at 4 week intervals
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Multi Center Prospective Registry of Infliximab Use for Childhood Uveitis

Baseline characteristics by cohort

Measure	5 mg/kg of Infliximab n=7 Participants 5mg/kg/does of infliximab IV at 4 week intervals	10 mg/kg of Infliximab n=6 Participants 10mg/kg/dose of infliximab Iv at 4 week intervals	Total n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 9 months

Population: 1 subject lost to follow up

Number of subjects with improvement in uveitis, defined as a two step decrease in level of inflammation (as defined by SUN criteria, AC cells, vitreous haze) or decrease to grade 0. A grading scheme of 0 indicating (<1 cell/ocular field) low levels of inflammation to 4+ indicating (>50 cells/ocular field) indicating high levels of inflammation.

Outcome measures

Measure	Infliximab 5mg/kg n=7 Participants 5mg/kg/does of infliximab IV at 4 week intervals	Infliximab 10mg/kg n=6 Participants 10mg/kg/dose of infliximab Iv at 4 week intervals
Effects of Infliximab on Uveitis Disease Activity.	3 participants Interval 0.0 to 4.0	6 participants Interval 0.0 to 4.0

Adverse Events

5 mg/kg of Infliximab

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

10 mg/kg of Infliximab

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	5 mg/kg of Infliximab n=7 participants at risk 5mg/kg/does of infliximab IV at 4 week intervals	10 mg/kg of Infliximab n=6 participants at risk 10mg/kg/dose of infliximab Iv at 4 week intervals
Infections and infestations Fever	0.00% 0/7	16.7% 1/6 • Number of events 1

Other adverse events

Measure	5 mg/kg of Infliximab n=7 participants at risk 5mg/kg/does of infliximab IV at 4 week intervals	10 mg/kg of Infliximab n=6 participants at risk 10mg/kg/dose of infliximab Iv at 4 week intervals
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	14.3% 1/7 • Number of events 1	16.7% 1/6 • Number of events 1
Skin and subcutaneous tissue disorders Fever blister	14.3% 1/7 • Number of events 1	0.00% 0/6
Ear and labyrinth disorders otitis media	0.00% 0/7	16.7% 1/6 • Number of events 1

Additional Information

Dr. C. Egla Rabinovich

Duke Health Systems

Phone: 919-668-0238

Email: egla.rabinovich@duke.edu

Results disclosure agreements

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