OHSU

IRB #

IRB00009024

Title

A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathrioprine for the Maintenance of Remission in Wegener's Granulomatosis and Microscopic Polyangiitis

Principal Investigator

Atulya Deodhar

Study Purpose

To evaluate the efficacy of belimumab in the maintenance of remission following a standard induction regimen in subjects with Wegener's granulomatosis (WG) or microscopic polyangiitis (MPA).

To evaluate the safety of belimumab in subjects with WG or MPA.

Medical Condition(s)

Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA)

Eligibility Criteria

1. At least 18 y.o.
2. Diagnosis of WG or MPA according to the Chapel Hill criteria
3. Had an episode of moderately to severely active WG or MPA in the 26 weeks before randomization
4. Evidence of anti-proteinase 3 (anti-PR3) or anti-myeloperoxidase prior to day 0.
5. Stable dose of non-systemic corticosteroids
6. Female subjects cannot be pregnant and if of child-bearing potential and sexually active, must be on some form of birth control.

Age Range

18 - 90

Healthy Volunteers Needed

No

Duration of Participation

Up to 3 years.

Minors Included

No

Contact

Tim Noland
Clinical Research Coordinator
Division of Arthritis & Rheumatic Diseases
Oregon Health & Science University
3181 SW Sam Jackson Park Road, Mail Code: OP-09
Portland, OR 97239

noland@ohsu.edu
Phone: (503) 494-5742
Fax: (503) 494-1022

Sponsor

Human Genome Sciences, Inc.
Glaxo Smith Kline. LLC

Recruitment End

06/30/2014

Compensation Provided

Yes

Compensation

$50.00 per visit. If all visits are completed as scheduled and the study continues for three years, each subject will be reimbursed $1900. If subjects are traveling >50 round-trip miles per study visit, they will be reimbursed according to the standard IRS mileage rate if the total reimbursement is greater than $50.00.


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