The Safety and Efficacy of Basiliximab as Maintenance Therapy in Subjects With Stable, Noninfectious Uveitis (BSX-003)

This study has been terminated.
Sponsor:
Collaborator:
PPD
Information provided by:
Cerimon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00646425
First received: March 26, 2008
Last updated: August 17, 2010
Last verified: August 2010
  Purpose

The objective of this trial is to assess if treatment with basiliximab allows subjects to taper off other immunosuppressive drug regimens without causing an increase in their uveitis.


Condition Intervention Phase
Non-infectious Uveitis
Drug: Basiliximab
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Masked, Placebo-controlled Evaluation of the Safety and Efficacy of Basiliximab as Maintenance Therapy in Subjects With Stable, Noninfectious Uveitis Who Undergo Tapering of Concomitant Immunosuppressive Medications

Resource links provided by NLM:


Further study details as provided by Cerimon Pharmaceuticals:

Primary Outcome Measures:
  • To prevent an increase in disease activity as measured by anterior cell count, vitreal haze and visual acuity while subjects with stable noninfectious uveitis undergo tapering of concomitant immunosuppressive medications [ Time Frame: The primary outcome will be assessed at Week 16 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary objectives are to assess changes in visual acuity, retinal thickness, corticosteroid dose, and immunosuppressive drug score. Basiliximab pharmacokinetics and immunogenicity will also be assessed [ Time Frame: These measures will be assessed at Week 16 ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: May 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Basiliximab
Drug: Basiliximab
40 mg basiliximab administered as short iv infusion once every 2 weeks for 3 doses and at Weeks 8 and 12 for a total of 5 doses
Other Name: Simulect
Placebo Comparator: 2 Drug: Placebo
Placebo to match basiliximab

  Eligibility

Ages Eligible for Study:   12 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of noninfectious intermediate, posterior or panuveitis of at least 3 months duration
  • Treatment with greater than or equal to 20 mg/day of Prednisone at baseline or immunosuppressive drug score of greater than or equal to 5 at baseline
  • BCVA by ETDRS protocol better than or equal to 20/200
  • Intraocular pressure of 24 mmHg or less
  • Anterior chamber cells and vitreous haze of less than or equal to 1
  • Male or females, aged 12 or greater, body weight of 40 kg or greater

Exclusion Criteria:

  • Prior treatment with Retisert
  • Primary diagnosis of anterior uveitis, uveitis of infectious etiology or Behcet's disease
  • Pregnancy or breast-feeding
  • Increase in systemic immunosuppressive treatment regimen within 6 weeks before baseline
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00646425

Locations
United States, Massachusetts
Ocular Immunology & Uveitis Foundation
Cambridge, Massachusetts, United States, 02142
United States, Missouri
Tauber Eye Center
Kansas City, Missouri, United States, 64111
United States, New York
New York Eye and Ear Infirmary
New York, New York, United States, 10003
United States, North Carolina
Southeast Clinical Research Associates
Belmont, North Carolina, United States, 28012
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Vitreoretinal Consultants
Houston, Texas, United States, 77030
Sponsors and Collaborators
Cerimon Pharmaceuticals
PPD
Investigators
Study Director: Shaily Reichert Cerimon Pharmaceuticals
  More Information

No publications provided

Responsible Party: Shaily Reichert, Cerimon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00646425     History of Changes
Other Study ID Numbers: BSX-003
Study First Received: March 26, 2008
Last Updated: August 17, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Cerimon Pharmaceuticals:
Non-infectious uveitis

Additional relevant MeSH terms:
Uveitis
Chorioretinitis
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior
Panuveitis
Basiliximab
Antibodies, Monoclonal
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014