Abatacept in the Treatment of Uveitis

This study is currently recruiting participants.

Verified May 2013 by Oregon Health and Science University

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: May 6, 2013

Last verified: May 2013

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:

Type, frequency and severity of adverse events. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

improvement by 2 or more lines of best-corrected visual acuity [ Time Frame: Week 16, 52, 76 and 104 ] [ Designated as safety issue: No ]
Reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50% [ Time Frame: Week 16, 52, 76 and 104 ] [ Designated as safety issue: No ]
Control of ocular inflammation, as judged on clinical criteria, according to standard methods [ Time Frame: Week 16, 52, 76 and 104 ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	20
Study Start Date:	January 2012
Estimated Primary Completion Date:	March 2015 (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
Genders Eligible for Study:	Both
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

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

Contacts

Contact: Eric B. Suhler, MD, MPH	503-494-5023	suhlere@ohsu.edu
Contact: Tracy R. Giles, BS	503-494-0482	gilest@ohsu.edu

Locations

United States, Oregon
Oregon Health & Science University	Recruiting
Portland, Oregon, United States, 97239
Contact: Tracy R Giles, BS 503-494-0482 gilest@ohsu.edu
Principal Investigator: Eric B Suhler, MD, MPH
Sub-Investigator: James T Rosenbaum, MD
Sub-Investigator: Justine Smith, MD

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

No publications provided

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:	May 6, 2013
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration

Additional relevant MeSH terms:

Uveitis
Chorioretinitis
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior

Panuveitis
Abatacept
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013

To Top