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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

January 14, 2011
May 6, 2013
January 2012
March 2015   (final data collection date for primary outcome measure)
Type, frequency and severity of adverse events. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01279954 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Abatacept in the Treatment of Uveitis
An Openlabel, Phase II Trial of Abatacept (Orencia) in the Treatment of Refractory Non-infectious Uveitis.

The purpose of this study is to assess the safety and efficacy of abatacept in the treatment of uveitis.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Uveitis
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: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Not Provided
March 2015   (final data collection date for primary outcome measure)

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
Both
6 Years and older
No
Contact: Eric B. Suhler, MD, MPH 503-494-5023 suhlere@ohsu.edu
Contact: Tracy R. Giles, BS 503-494-0482 gilest@ohsu.edu
United States
 
NCT01279954
e7035
Not Provided
Eric B. Suhler, Oregon Health and Science University
Oregon Health and Science University
Bristol-Myers Squibb
Principal Investigator: Eric B. Suhler, MD, MPH Oregon Health and Science University
Study Director: James T Rosenbaum, MD Oregon Health and Science University
Oregon Health and Science University
May 2013

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