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-DE

Lead Sponsor: Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

Brief Summary: Not available

Detailed Description: Not available

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

Primary Outcome Measures

Name	Time	Method
Main Objective: •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).<br>•To evaluate the safety of belimumab in subjects with WG or MPA.<br>;Secondary Objective: NA;Primary end point(s): The primary efficacy endpoint is time from Day 0 to the first relapse, defined as: <br>•At least 1 major BVAS item OR <br>•A minimum total BVAS score of 6 OR<br>•Receipt of protocol prohibited medications.;Timepoint(s) of evaluation of this end point: 12 months have elapsed after the last subject is randomised

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Time from Day 0 to the first major relapse (defined as experiencing at least 1 major BVAS item);Timepoint(s) of evaluation of this end point: 12 months have elapsed after the last subject is randomised

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