Trial Outcomes & Findings for Rituximab in the Treatment of Scleritis and Non-Infectious Orbital Inflammation (NCT NCT00415506)

Results Overview

Reduction (decrease in dosage) of systemic corticosteroids or immunosuppressive therapy by at least 50% by 24 weeks.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

20 participants

Primary outcome timeframe

24 Weeks

Results posted on

2013-08-16

Participant Flow

Subjects were recruited from January 2007 through March of 2010. Subjects were recruited from the investigator's medical clinic.

Of the 20 subjects enrolled, two subjects had both orbital disease and scleritis. These two subjects were followed for both indications.

Participant milestones

Participant milestones
Measure	Scleritis Patients with non-infectious scleritis and is a phase II, randomized, double-blinded, prospective clinical trial of two different doses of rituximab to compare the safety and efficacy of these 2 doses. Patients will be randomized to either 500 mg or 1000 mg of rituximab administered intravenously two weeks apart.	Orbital Inflammation Patients with non-infectious orbital inflammatory disease, and is a phase I, prospective clinical trial to examine the safety of the 2 infusions of rituximab intravenously, 2 weeks apart, in the treatment of non-infectious orbital inflammation. The first 5 patients will receive 1000 mg of rituximab at each infusion, any additional patients will be randomized to receive either 500 mg or 1000 mg of rituximab.
Overall Study STARTED	12	10
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rituximab in the Treatment of Scleritis and Non-Infectious Orbital Inflammation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Scleritis n=12 Participants Subjects with Scleritis	Orbital Inflammation n=10 Participants Subjects with Orbital Inflammation	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=93 Participants	8 Participants n=4 Participants	20 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	7 Participants n=4 Participants	15 Participants n=27 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Region of Enrollment United States	12 participants n=93 Participants	10 participants n=4 Participants	22 participants n=27 Participants

PRIMARY outcome

Timeframe: 24 Weeks

Population: Only patients currently on systemic corticosteroids were analyzed for this outcome point.

Reduction (decrease in dosage) of systemic corticosteroids or immunosuppressive therapy by at least 50% by 24 weeks.

Outcome measures

Outcome measures
Measure	Scleritis n=11 Participants Subjects with Scleritis	Orbital Inflammation n=6 Participants Subjects with Orbital Inflammation
Reduction of Medications	5 participants	4 participants

PRIMARY outcome

Timeframe: 24 weeks

For patients with scleritis, disease activity as measured by a modified grading system first described by McCluskey et al. (McCluskey and Wakefield 1987; McCluskey and Wakefield 1991). Improvement in scleritis activity will be defined as a reduction in this grading score of 2 or more, or an overall score of 4 or less by 24 weeks. For patients with orbital inflammation, disease activity as measured by a modified grading system first devised by Werner (Werner 1977). Improvement in orbital inflammation will be defined as a reduction in this grading score of 2 or more, or an overall score of 3 or less.

Outcome measures

Outcome measures
Measure	Scleritis n=12 Participants Subjects with Scleritis	Orbital Inflammation n=10 Participants Subjects with Orbital Inflammation
Improved Control of Inflammation	9 participants	7 participants

Adverse Events

Orbital Inflammation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Scleritis

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 B. 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