Trial information
A Study of Ocrelizumab in Patients With Rheumatoid Arthritis.
Status: No longer recruiting
Protocol number: WA18230
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind, dose-escalating study of the effect of a single dose of ocrelizumab on treatment response in patients with moderate to severe rheumatoid arthritis with unsatisfactory response to stable doses of concomitant methotrexate
Brief summary: This study will evaluate the safety, tolerability and efficacy of ocrelizumab compared with placebo in combination with methotrexate in patients with moderate to severe rheumatoid arthritis (RA). The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.
Target sample size is 160.
Study phase: II
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
Condition: Rheumatoid Arthritis
Intervention type: Drug
Intervention name: ocrelizumab
Primary outcome: 1. Safety: Adverse events,laboratory parameters, immunology
Key secondary outcomes: 1. Efficacy: Percentage of patients with clinical response (ACR) of 20%, 50%, and 70%, disease activity score and proportion of EULAR responders
Inclusion criteria:
- adult patients 18-80 years of age;
- RA for >=6 months;
- treatment failure with >=1 but <=5 drugs, other than methotrexate;
- current treatment with methotrexate for at least 12 weeks, at a stable dose.
Exclusion criteria:
- rheumatic autoimmune disease or inflammatory joint disease, other than RA;
- previous treatment with rituximab;
- concurrent treatment with any DMARD (other than methotrexate) or any anti-TNF-a or other biologic therapy.
Gender: Males or Females
Age limits: Min: 18 Years Max: 80 Years
Accepts healthy volunteers: No
Anticipated start date: March, 2005
Trial registration date: 07/26/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Australia
Belgium
Canada
- Calgary, AB
- Edmonton, AB
- London, ON
- Toronto, ON
- Quebec City, QC
- Sherbrooke, QC
Netherlands
New Zealand
Russian Federation
Spain
- Alcorcon
- Cádiz
- Granada
- La Laguna
- Madrid
- Santiago de Compostela
- Sevilla
- Valencia
United Kingdom
- Aberdeen
- Cambridge
- Derby
- Leeds
- Liverpool
- London
- Maidstone
- Norwich
- Salford
- West Midlands
