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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01663623
Other study ID # 115466
Secondary ID
Status Completed
Phase Phase 3
First received August 9, 2012
Last updated November 27, 2017
Start date March 20, 2013
Est. completion date February 6, 2017

Study information

Verified date November 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of belimumab, in combination with azathioprine, for the maintenance of remission following a standard induction regimen in patients with Wegener's granulomatosis or microscopic polyangiitis. The random assignment in this study is "1 to 1" which means that participants have an equal chance of receiving belimumab or placebo.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date February 6, 2017
Est. primary completion date February 6, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key 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 21 to 35 days apart.

- Maintenance therapy on this study must start no more than 2 weeks after confirmation of remission.

Key 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 past 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.

- History of severe allergic reaction to contrast agents or biological medicines.

Study Design


Intervention

Biological:
Placebo
Placebo
Belimumab 10 mg/kg
Belimumab 10 mg/kg
Drug:
Azathioprine
Azathioprine

Locations

Country Name City State
Australia GSK Investigational Site Garran Australian Capital Territory
Australia GSK Investigational Site Liverpool
Australia GSK Investigational Site Malvern Victoria
Australia GSK Investigational Site New Lambton New South Wales
Belgium GSK Investigational Site Brussels
Belgium GSK Investigational Site Bruxelles
Belgium GSK Investigational Site Leuven
Canada GSK Investigational Site Hamilton Ontario
Canada GSK Investigational Site Montreal Quebec
Canada GSK Investigational Site Montreal Quebec
Canada GSK Investigational Site Toronto Ontario
Czechia GSK Investigational Site Praha 2
Czechia GSK Investigational Site Praha 2
Czechia GSK Investigational Site Praha 4
France GSK Investigational Site Lille cedex
France GSK Investigational Site Paris
France GSK Investigational Site Pessac
France GSK Investigational Site Rennes
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Jena Thueringen
Germany GSK Investigational Site Kirchheim unter Teck
Germany GSK Investigational Site Leipzig Sachsen
Germany GSK Investigational Site Muenchen
Germany GSK Investigational Site Muenster Nordrhein-Westfalen
Germany GSK Investigational Site Stuttgart Baden-Wuerttemberg
Germany GSK Investigational Site Tuebingen Baden-Wuerttemberg
Hungary GSK Investigational Site Budapest
Hungary GSK Investigational Site Debrecen
Ireland GSK Investigational Site Dublin
Ireland GSK Investigational Site Dublin
Italy GSK Investigational Site Bari
Italy GSK Investigational Site Bologna
Italy GSK Investigational Site Genova Liguria
Italy GSK Investigational Site Milano
Italy GSK Investigational Site Reggio Emilia
Italy GSK Investigational Site Torrette Di Ancona Marche
Mexico GSK Investigational Site Mexico
Norway GSK Investigational Site Kristiansand
Norway GSK Investigational Site Oslo
Peru GSK Investigational Site Callao
Peru GSK Investigational Site Lima
Peru GSK Investigational Site Lima
Peru GSK Investigational Site Lima
Peru GSK Investigational Site Lima
Peru GSK Investigational Site Lima
Peru GSK Investigational Site Lima
Poland GSK Investigational Site Gdansk
Poland GSK Investigational Site Katowice
Poland GSK Investigational Site Krakow
Poland GSK Investigational Site Lublin
Romania GSK Investigational Site Bucharest
Romania GSK Investigational Site Cluj-Napoca
Russian Federation GSK Investigational Site Moscow
Russian Federation GSK Investigational Site Saint-Petersburg
Russian Federation GSK Investigational Site Stavropol
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Barcelona
Spain GSK Investigational Site Madrid
Sweden GSK Investigational Site Stockholm
Switzerland GSK Investigational Site Bern
Switzerland GSK Investigational Site St. Gallen
Switzerland GSK Investigational Site Zuerich
United Kingdom GSK Investigational Site Aberdeen
United Kingdom GSK Investigational Site Cambridge
United Kingdom GSK Investigational Site London
United Kingdom GSK Investigational Site Oxford
United Kingdom GSK Investigational Site Reading Berkshire
United States GSK Investigational Site Birmingham Alabama
United States GSK Investigational Site Boston Massachusetts
United States GSK Investigational Site Camden New Jersey
United States GSK Investigational Site Chicago Illinois
United States GSK Investigational Site Columbus Ohio
United States GSK Investigational Site Covina California
United States GSK Investigational Site Detroit Michigan
United States GSK Investigational Site Great Neck New York
United States GSK Investigational Site Kansas City Kansas
United States GSK Investigational Site Milwaukee Wisconsin
United States GSK Investigational Site Mobile Alabama
United States GSK Investigational Site New York New York
United States GSK Investigational Site New York New York
United States GSK Investigational Site Palo Alto California
United States GSK Investigational Site Philadelphia Pennsylvania
United States GSK Investigational Site Pittsburgh Pennsylvania
United States GSK Investigational Site Portland Oregon
United States GSK Investigational Site Rochester Minnesota
United States GSK Investigational Site San Leandro California
United States GSK Investigational Site Tucson Arizona
United States GSK Investigational Site West Springfield Massachusetts
United States GSK Investigational Site Wyomissing Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Human Genome Sciences Inc., a GSK Company GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czechia,  France,  Germany,  Hungary,  Ireland,  Italy,  Mexico,  Norway,  Peru,  Poland,  Romania,  Russian Federation,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to first relapse Relapse is defined as at least 1 major item on the Birmingham Vasculitis Activity Score (BVAS), or a minimum total BVAS score of 6, or receipt of a protocol prohibited medication. Approximately 3 years
Secondary Time to first major relapse Major relapse is defined as having at least 1 major item on the BVAS. Approximately 3 years
Secondary Number of participants who experienced adverse events Approximately 3 years
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