Abatacept in the Treatment of Uveitis

NCT01279954 | Completed Phase 2 Results

• 1 other identifier: e7035
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and efficacy of abatacept in the treatment of uveitis.

Conditions

Uveitis

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  number of participants with adverse events

  2 years

Secondary Outcomes (3)

• Number of Participants With Improvement by 2 or More Lines of Best-corrected Visual Acuity

  Week 24

• Number of Participants With Reduction in Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%

  Week 24

• Number of Participants With Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods

  Week 24

Study Arms (2)

open-label abatacept first, then 5 mg/kg abatacept

EXPERIMENTAL

10 mg/kg abatacept (6 months). Then 5 mg/kg abatacept (18 months)

Drug: Abatacept

open-label abatacept first, then 10 mg/kg abatacept

EXPERIMENTAL

10 mg/kg abatacept (6 months). Then 10 mg/kg abatacept (18 months)

Drug: Abatacept

Interventions

Abatacept DRUG

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.

Also known as: orencia

open-label abatacept first, then 10 mg/kg abatacept; open-label abatacept first, then 5 mg/kg abatacept

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• serious concomitant illness that could interfere with the subject's participation

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Uveitis

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Results Point of Contact

• Title: Eric Suler, MD
• Organization: Oregon Health & Science University

suhlere@ohsu.edu

503-494-5023

Study Officials

• Eric B. Suhler, MD, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• James T Rosenbaum, MD

  Oregon Health and Science University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: January 20, 2011
• Study Start: January 1, 2012
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: February 21, 2019
• Results First Posted: February 21, 2019

Record last verified: 2019-01

Locations

US (1)