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Trial information
A Study of Ocrelizumab in Patients With Systemic Lupus Erythematosus.
Status: Recruiting
Protocol number: WA20499
Sponsor: Hoffmann-La Roche; Genentech Inc.
Company division: Pharmaceutical
Official Scientific Title: A Randomized, Double-Blind Study of the Effect of Ocrelizumab on Signs and Symptoms in Patients with Active 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 active, moderate to severe systemic lupus erythematosus. Patients will be randomized to receive ocrelizumab 1000mg i.v., ocrelizumab 400mg i.v. or placebo i.v. on days 1 and 15, and at week 16, 32 and 48. All patients will also receive standard of care immunosuppression and a standard steroid regimen. The anticipated time on study treatment is2+ years, and the target sample size is 100-500 individuals.In the US this study is sponsored/managed by Genentech. Target sample size is 423.
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. Proportions of patients at week 48 with 1) major clinical response 2) partial clinical response and 3) no clinical response assessed by BILAG.
Key secondary outcomes: 1. Safety: AEs and laboratory parameters, corticosteroid-sparing, frequency of disease flares. SLEDAI-2K and SDI. QoL: SF-36, FACIT fatigue and mBPI-SF.
Inclusion criteria: - male or female patients, >=16 years of age;
- diagnosis of systemic lupus erythematosus;
- active disease at screening;
- background use of AZA, MMF or MTX for >=60 days prior to baseline.
Exclusion criteria: - active moderate to severe glomerulonephritis;
- treatment with a second immunosuppressive or immunomodulatory drug in 8 weeks prior to baseline;
- 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: December, 2007
Trial registration date: 11/14/2007
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:Argentina - Buenos Aires
- San Miguel De Tucuman
Brazil - Belo Horizonte
- Brasilia
- Curitiba
- Fortaleza
- Goiania
- Porto Alegre
- Recife
- Ribeirão Preto
- Rio De Janeiro
- Sao Paulo
Bulgaria Canada - Vancouver, BC
- London, ON
- Toronto, ON
- Sherbrooke, QC
Chile - Concepcion
- Puente Alto
- Santiago
China - Beijing
- Guangzhou
- Harbin
- Hong Kong
- Jinan
- Nanjing
- Shanghai
- Shenyang
- Suzhou
- Wuhan
Colombia - Barranquilla
- Bogota
- Bucaramanga
- Medellin
Costa Rica France Germany - Bad Abbach
- Bad Bramstedt
- Düsseldorf
- Erlangen
- Hamburg
- Tübingen
Hungary Malaysia - Kuching
- Nilai, Negeri Sembilan
Mexico - Guadalajara
- Mexico City
- Obregon
- San Luis Potosi
Netherlands Peru Philippines Poland Portugal Russian Federation - Moscow
- St Petersburg
- Yaroslavl
Serbia and Montenegro Singapore South Africa Spain Sweden Thailand United Kingdom - Birmingham
- Cambridge
- Derby
- Leeds
- London
- Manchester
- Newcastle upon Tyne
- Stoke-on-Trent
United States - Los Angeles, CA
- Palo Alto, CA
- San Leandro, CA
- Farmington, CT
- Boca Raton, FL
- Tampa, FL
- Boise, ID
- Kansas City, KS
- New Orleans, LA
- Baltimore, MD
- Boston, MA
- Ann Arbor, MI
- St Louis, MO
- Lebanon, NH
- New York, NY
- Orchard Park, NY
- Chapel Hill, NC
- Charlotte, NC
- Durham, NC
- Wilmington, NC
- Cincinnati, OH
- Cleveland, OH
- Portland, OR
- Bethlehem, PA
- Philadelphia, PA
- Charleston, SC
- Memphis , TN
- Amarillo, TX
- Dallas, TX
- Houston, TX
- Mesquite, TX
- Temple, TX
- Vancouver , WA
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