Trial information
A Study of Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus.
Status: Recruiting
Protocol number: WA20500
Sponsor: Hoffmann-La Roche; Genentech Inc.
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind study of the effect of ocrelizumab on renal response in patients with class III or IV nephritis due to systemic lupus erythematosus
Brief summary: This 3 arm study will evaluate the efficacy and safety of 2 doses of ocrelizumab compared with placebo in patients with ISN/RPS or WHO class III or IV lupus nephritis. Patients will be randomized to receive ocrelizumab 1000mg iv, ocrelizumab 400mg iv or placebo iv on days 1 and 15, week 16 and every 16 weeks thereafter. All patients will also receive a standard immunosuppressant regimen of either mycopnenolate mofetil, or cyclophosphamide followed by azathioprine. All arms will also receive a standard steroid regimen. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.In the US this study is sponsored/managed by Genentech. Target sample size is
369.
Study phase: III
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
Condition: Systemic Lupus Erythematosus
Intervention type: Drug
Intervention name: ocrelizumab
Primary outcome: 1. Proportion of patients at week 48 with a Complete Renal Response, Partial Renal Response or no response, assessed by renal function, urinary sediment and proteinuria.
Key secondary outcomes: 1. Efficacy: BILAG, SLEDAI-2K. Safety: AEs and laboratory parameters. SDI. QoL: SF-36, FACIT fatigue, mBPI, Health Care Utilization.
Inclusion criteria:
- male or female patients, >=16 years of age;
- diagnosis of systemic lupus erythematosus;
- WHO or ISN class III or IV active lupus nephritis.
Exclusion criteria:
- severe renal impairment;
- previous treatment with a B cell directed therapy (other than one directed at BAFF).
Gender: Males or Females
Age limits: Min: 16 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: February, 2008
Trial registration date: 11/14/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Argentina
- Buenos Aires
- Córdoba
- San Juan
- San Miguel De Tucuman
- Tucuman
Brazil
- Belo Horizonte
- Brasilia
- Curitiba
- Fortaleza
- Goiania
- Marilia
- Porto Alegre
- Recife
- Ribeirão Preto
- Rio De Janeiro
- Sao Paulo
Bulgaria
Canada
- Scarborough, ON
- Toronto, ON
Chile
- Concepcion
- Puente Alto
- Santiago
China
- Beijing
- Guangzhou
- Harbin
- Hong Kong
- Jinan
- Nanjing
- Nanning
- Shanghai
- Shenyang
- Wuhan
Colombia
- Barranquilla
- Bogota
- Bogotá
- Bucaramanga
- Cali
- Medellin
Costa Rica
France
- Creteil
- Le Kremlin-Bicetre
- Lille
- Paris
- Strasbourg
Germany
- Bad Abbach
- Bad Bramstedt
- Berlin
- Düsseldorf
- Erlangen
- Hamburg
- Hannover
- Heidelberg
- Tübingen
Hungary
Indonesia
- Bandung
- Jakarta
- Malang
- Medan
Malaysia
- Johor Bahru
- Kuala Lumpur
- Kuching
Mexico
- Chihuahua
- Guadalajara
- Mexico City
- Obregon
- San Luis Potosi
Netherlands
- Amsterdam
- Groningen
- Nijmegen
Peru
Philippines
- Cebu City
- Iloilo City
- Manila
- Quezon City
Poland
- Bydgoszcz
- Katowice
- Krakow
- Lodz
- Lublin
- Szczecin
- Warszawa
- Wroclaw
Portugal
Romania
Russian Federation
- Kazan
- Moscow
- St Petersburg
- Yaroslavl
Serbia and Montenegro
Singapore
South Africa
Spain
- Barcelona
- Madrid
- Malaga
- Sevilla
Sweden
- Huddinge
- Lund
- Stockholm
- Uppsala
Taiwan
- Kaohsiung
- Taichung
- Taoyuan
Thailand
- Bangkok
- Chiang Mai
- Khon Kaen
- Phitsanulok
- Songkhla
Turkey
- Adana
- Ankara
- Istanbul
- Izmir
United Kingdom
- Birmingham
- Cambridge
- Derby
- Leeds
- London
- Manchester
United States
- Tempe, AZ
- Los Angeles, CA
- San Leandro, CA
- Washington, DC
- Miami, FL
- Atlanta, GA
- Augusta, GA
- Chicago, IL
- Kansas City, KS
- Rochester, MN
- Manhasset, NY
- New York, NY
- Rochester, NY
- Charlotte, NC
- Wilmington, NC
- Cincinnati, OH
- Columbus, OH
- Portland, OR
- Bethlehem, PA
- Charleston, SC
- Amarillo, TX
- Dallas, TX
- El Paso, TX
- Houston, TX
- San Antonio, TX
- Temple, TX
