Abatacept in the Treatment of Uveitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 6, 2014
Last verified: June 2014
  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:


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
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

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: June 6, 2014
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
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014