Abatacept in the Treatment of Uveitis
Information source: Oregon Health and Science University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Uveitis
Intervention: Abatacept (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Oregon Health and Science University Official(s) and/or principal investigator(s):
Eric B. Suhler, MD, MPH, Principal Investigator, Affiliation: Oregon Health and Science University
James T Rosenbaum, MD, Study Director, Affiliation: Oregon Health and Science University
Overall contact:
Eric B. Suhler, MD, MPH, Phone: 503-494-5023, Email: suhlere@ohsu.edu
Summary
The purpose of this study is to assess the safety and efficacy of abatacept in the treatment
of uveitis.
Clinical Details
Official title: An Openlabel, Phase II Trial of Abatacept (Orencia) in the Treatment of Refractory Non-infectious Uveitis.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Type, frequency and severity of adverse events.
Secondary outcome: improvement by 2 or more lines of best-corrected visual acuityReduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50% Control of ocular inflammation, as judged on clinical criteria, according to standard methods
Eligibility
Minimum age: 6 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Eric B. Suhler, MD, MPH, Phone: 503-494-5023, Email: suhlere@ohsu.edu
Oregon Health & Science University, Portland, Oregon 97239, United States; Recruiting
Tracy R Giles, BS, Phone: 503-494-0482, Email: gilest@ohsu.edu
Eric B Suhler, MD, MPH, Principal Investigator
James T Rosenbaum, MD, Sub-Investigator
Justine Smith, MD, Sub-Investigator
Additional Information
Starting date: January 2012
Last updated: August 31, 2012
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