Abatacept in the Treatment of Uveitis

NCT ID: NCT01279954

Last Updated: 2019-02-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2017-06-30

Brief Summary

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The purpose of this study is to assess the safety and efficacy of abatacept in the treatment of uveitis.

Detailed Description

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Conditions

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Uveitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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open-label abatacept first, then 5 mg/kg abatacept

10 mg/kg abatacept (6 months). Then 5 mg/kg abatacept (18 months)

Group Type EXPERIMENTAL

Abatacept

Intervention Type DRUG

Subjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial. At 6 months subjects will then be randomized to receive either 5 mg/kg or 10 mg/kg.

Abatacept will be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept will be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter for up to 2 years.

open-label abatacept first, then 10 mg/kg abatacept

10 mg/kg abatacept (6 months). Then 10 mg/kg abatacept (18 months)

Group Type EXPERIMENTAL

Abatacept

Intervention Type DRUG

Subjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial. At 6 months subjects will then be randomized to receive either 5 mg/kg or 10 mg/kg.

Abatacept will be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept will be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter for up to 2 years.

Interventions

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Abatacept

Subjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial. At 6 months subjects will then be randomized to receive either 5 mg/kg or 10 mg/kg.

Abatacept will be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept will be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter for up to 2 years.

Intervention Type DRUG

Other Intervention Names

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orencia

Eligibility Criteria

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Inclusion Criteria

* patients with vision-threatening autoimmune uveitis
* failure to respond to prednisone and at least one other systemic immunosuppressive, or intolerance to such medications due to side effects

Exclusion Criteria

* serious concomitant illness that could interfere with the subject's participation
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Eric B. Suhler

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric B. Suhler, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

James T Rosenbaum, MD

Role: STUDY_DIRECTOR

Oregon Health and Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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e7035

Identifier Type: -

Identifier Source: org_study_id

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