Abatacept in the Treatment of Uveitis

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Bristol-Myers Squibb

Information provided by (Responsible Party):

Eric B. Suhler, Oregon Health and Science University

ClinicalTrials.gov Identifier:

NCT01279954

First received: January 14, 2011

Last updated: July 7, 2016

Last verified: July 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

January 14, 2011

Last Updated Date

July 7, 2016

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

June 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Type, frequency and severity of adverse events. [ Time Frame: 2 years ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01279954 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

improvement by 2 or more lines of best-corrected visual acuity [ Time Frame: Week 16, 52, 76 and 104 ]
Reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50% [ Time Frame: Week 16, 52, 76 and 104 ]
Control of ocular inflammation, as judged on clinical criteria, according to standard methods [ Time Frame: Week 16, 52, 76 and 104 ]
Reduction of AC cellular activity and/or vitreous haze by 2 grades. Reduction of chorioretinal infiltrates or reduction of retinal vasculitis. Reduction of cystoid macular edema and/or retinal inflammation.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Abatacept in the Treatment of Uveitis

Official Title ^ICMJE

An Openlabel, Phase II Trial of Abatacept (Orencia) in the Treatment of Refractory Non-infectious Uveitis.

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Uveitis

Intervention ^ICMJE

Drug: 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.

Other Name: orencia

Study Arms

Experimental: open-label abatacept
Intervention: Drug: Abatacept
Experimental: 5 mg/kg abatacept
At 6 months subjects will be randomized to receive either 5 mg/kg abatacept or 10 mg/kg abatacept.

Intervention: Drug: Abatacept
Experimental: 10 mg/kg abatacept
Intervention: Drug: Abatacept

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

June 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

6 Years and older (Child, Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01279954

Other Study ID Numbers ^ICMJE

e7035

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Eric B. Suhler, Oregon Health and Science University

Study Sponsor ^ICMJE

Oregon Health and Science University

Collaborators ^ICMJE

Bristol-Myers Squibb

Investigators ^ICMJE

Principal Investigator:	Eric B. Suhler, MD, MPH	Oregon Health and Science University
Study Director:	James T Rosenbaum, MD	Oregon Health and Science University

PRS Account

Oregon Health and Science University

Verification Date

July 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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