Trial Outcomes & Findings for Tocilizumab in the Management of Juvenile Idiopathic Arthritis Associated Uveitis (NCT NCT01603355)

Results Overview

control of anterior chamber cell in both eyes at week 16 to a level of trace or less (SUN criteria) without an increase in any immunosuppressive treatment and while using prednisolone acetate topically no more than 2 times per day

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

3 participants

Primary outcome timeframe

16 Weeks

Results posted on

2019-01-14

Participant Flow

Participant milestones

Participant milestones
Measure	Tocilizumab Tocilizumab: Intravenous tocilizumab: Patients less than 30 kg weight:10 mg per kg every 4 weeks Patients at or above 30 kg weight: 8 mg per kg every 4 weeks
Overall Study STARTED	3
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Tocilizumab Tocilizumab: Intravenous tocilizumab: Patients less than 30 kg weight:10 mg per kg every 4 weeks Patients at or above 30 kg weight: 8 mg per kg every 4 weeks
Overall Study Lack of Efficacy	2

Baseline Characteristics

Tocilizumab in the Management of Juvenile Idiopathic Arthritis Associated Uveitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tocilizumab n=3 Participants Tocilizumab: Intravenous tocilizumab: Patients less than 30 kg weight:10 mg per kg every 4 weeks Patients at or above 30 kg weight: 8 mg per kg every 4 weeks
Age, Categorical <=18 years	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants
Participants with control of ocular inflammation at trace or less	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 16 Weeks

control of anterior chamber cell in both eyes at week 16 to a level of trace or less (SUN criteria) without an increase in any immunosuppressive treatment and while using prednisolone acetate topically no more than 2 times per day

Outcome measures

Outcome measures
Measure	Tocilizumab n=3 Participants Tocilizumab: Intravenous tocilizumab: Patients less than 30 kg weight:10 mg per kg every 4 weeks Patients at or above 30 kg weight: 8 mg per kg every 4 weeks
Number of Participants With Control of Ocular Inflammation	1 Participants

Adverse Events

Tocilizumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Eric Suhler

Oregon Health & Science University

Phone: 503-494-5023

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place