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

Purpose

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

Condition	Intervention	Phase
Uveitis	Drug: Abatacept	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	An Openlabel, Phase II Trial of Abatacept (Orencia) in the Treatment of Refractory Non-infectious Uveitis.

Resource links provided by NLM:

Drug Information available for: Abatacept

Genetic and Rare Diseases Information Center resources: Uveal Diseases

U.S. FDA Resources

Further study details as provided by Eric B. Suhler, Oregon Health and Science University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.


Enrollment:	10
Study Start Date:	January 2012
Estimated Primary Completion Date:	June 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: open-label abatacept	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
Experimental: 5 mg/kg abatacept At 6 months subjects will be randomized to receive either 5 mg/kg abatacept or 10 mg/kg abatacept.	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
Experimental: 10 mg/kg abatacept	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

Eligibility


Ages Eligible for Study:	6 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279954

Locations


United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239

Sponsors and Collaborators

Oregon Health and Science University

Bristol-Myers Squibb

Investigators


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

More Information


Responsible Party:	Eric B. Suhler, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT01279954 History of Changes
Other Study ID Numbers:	e7035
Study First Received:	January 14, 2011
Last Updated:	July 7, 2016

Additional relevant MeSH terms:


Uveitis Uveal Diseases Eye Diseases Abatacept	Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents

ClinicalTrials.gov processed this record on July 11, 2017

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