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

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ClinicalTrials.gov Identifier: NCT00646425
Recruitment Status : Terminated
First Posted : March 28, 2008
Last Update Posted : August 19, 2010
Sponsor:
Collaborator:
PPD
Information provided by:
Cerimon Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Non-infectious Uveitis Drug: Basiliximab Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : May 2008
Primary Completion Date : November 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Basiliximab
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Shaily Reichert, Cerimon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00646425     History of Changes
Other Study ID Numbers: BSX-003
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: August 19, 2010
Last Verified: August 2010

Keywords provided by Cerimon Pharmaceuticals:
Non-infectious uveitis

Additional relevant MeSH terms:
Uveitis
Uveal Diseases
Eye Diseases
Basiliximab
Antibodies, Monoclonal
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs