Belimumab in Remission of Vasculitis

Phase 1

• Conditions: Wegener’s granulomatosis (WG)Microscopic polyangiitis (MPA)Vasculitis; MedDRA version: 18.0Level: LLTClassification code 10047888Term: Wegener's granulomatosisSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 18.0Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-004569-33-CZ
• Lead Sponsor: Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-21
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•Clinical diagnosis Wegener's granulomatosis or microscopic polyangiitis by Chapel Hill criteria.
•Disease flare in the past 26 weeks requiring treatment with high dose corticosteroids and 1 of the following medications: rituximab, oral cyclophosphamide OR IV cyclophosphamide.
•Tested positive for anti-proteinase 3 (anti-PR3) or anti-myeloperoxidase (anti-MPO) antibodies at any time prior to enrollment.
•Achieve remission no more than 26 weeks after first dose of induction treatment. Remission is defined as a Birmingham Vasculitis Activity (BVAS) score of 0 and receiving less than 10 mg/day of oral prednisone (or equivalent) on 2 consecutive visits at least 14 days apart, between 6 and 26 weeks after the first dose of induction therapy.
•Maintenance therapy on this study must start no more than 2 weeks after confirmation of remission.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

•Pregnant or nursing.
•Receipt of a B cell targeted therapy (other than rituximab) at anytime
•Receipt of an investigational biological agent within the 60 days.
•Required management of acute or chronic infections within the past 60 days.
•Current drug or alcohol abuse or dependence.
•Current or past positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C or abnormal liver function tests.
•History of severe allergic reaction to contrast agents or biological medicines.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified