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Abatacept in the Treatment of Uveitis

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ClinicalTrials.gov Identifier: NCT01279954
Recruitment Status : Active, not recruiting
First Posted : January 20, 2011
Last Update Posted : July 11, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to assess the safety and efficacy of abatacept in the treatment of uveitis.

Condition or disease Intervention/treatment Phase
Uveitis Drug: Abatacept Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (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.
Study Start Date : January 2012
Estimated Primary Completion Date : June 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Secondary Outcome Measures :
  1. improvement by 2 or more lines of best-corrected visual acuity [ Time Frame: Week 16, 52, 76 and 104 ]
  2. Reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50% [ Time Frame: Week 16, 52, 76 and 104 ]
  3. 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.


Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: January 20, 2011    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Uveitis
Uveal Diseases
Eye Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents