Trial information

A Study of Tocilizumab in Patients With Active Systemic Juvenile Idiopathic Arthritis

Status: Recruiting

Protocol number: WA18221

Sponsor: Hoffmann-La Roche

Company division: Pharmaceutical

Official Scientific Title: A randomized, placebo-controlled study to evaluate the effect of tocilizumab on disease response in patients with active systemic juvenile idiopathic arthritis, with an open-label extension to examine the long term use of tocilizumab

Brief summary: This study will evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA) who have an inadequate clinical response to NSAIDs and corticosteroids. In Part 1 of the study patients will be randomized 2:1 to receive iv infusions of tocilizumab (8mg/kg iv for patients >=30kg, or 12mg/kg for patients <30kg) or placebo, every 2 weeks. Stable NSAIDs and methotrexate will be continued throughout. After 12 weeks of double-blind treatment, all patients will have the option to enter Part 2 of the study to receive open-label treatment with tocilizumab for a further 92 weeks. The anticipated time on study treatment is 2 years, and the target sample size is 100-500 individuals. Target sample size is 108.

Study phase: III

Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study

Condition: Juvenile Idiopathic Arthritis

Intervention type: Drug

Intervention name: tocilizumab

Primary outcome: 1. Proportion of patients with >=30% improvement in JIA core set and absence of fever Time frame: Week 12

Key secondary outcomes: 1. % patients with 30/50/70/90% improvement in JIA core set; reduction in steroid use; change in individual components of JIA core set; change in hsCRP, anemia, platelet count, total WBC, incidence of rash;improvement in CHAQ, and VAS Time frame: Week 12 2. Time from baseline to achievement of JIA ACR 30/50/70/90 Time frame: Throughout study 3. AEs, lab parameters Time frame: Throughout study

Inclusion criteria:

• patients aged 2-17 years of age;
• systemic JIA with >= 6 months persistent activity;
• presence of active disease (>=5 active joints, or >=2 active joints + fever + steroids);
• inadequate clinical response to NSAIDs and corticosteroids due to toxicity or lack of efficacy.

Exclusion criteria:

• wheelchair or bed-ridden;
• any other autoimmune, rheumatic disease or overlap syndrome other than sJIA;
• intravenous long-acting corticosteroids or intra-articular corticosteroids within 4 weeks of baseline, or throughout study;
• DMARDs (other than methotrexate);
• previous treatment with tocilizumab.

Gender: Males or Females

Age limits: Min: 2 Years Max: 17 Years

Accepts healthy volunteers: No

Anticipated start date: May, 2008

Trial registration date: 03/18/2008

Date last updated: 11/21/2008

Link to trial result

This trial is being conducted at the following locations:

Argentina

• Buenos Aires
• Córdoba
• La Plata

Australia

• Parkville
• Subiaco
• Westmead

Belgium

• Gent
• Leuven

Brazil

• Porto Alegre
• Rio De Janeiro
• Sao Paulo

Canada

• Vancouver, BC
• Halifax, NS
• Ottawa, ON
• Toronto, ON

Czech Republic

• Praha

Denmark

• Århus
• København

France

• Bron
• Le Kremlin Bicêtre
• Paris

Germany

• Berlin
• Bremen
• Hamburg
• Sankt Augustin

Greece

• Athens
• Heraklion
• Ioannina

Italy

• Genova
• Milano
• Padova
• Roma

Mexico

• Mexico City

Netherlands

• Leiden
• Utrecht

Norway

• Oslo

Poland

• Lublin

Slovakia

• Piestany

Spain

• Barcelona
• Esplugas De Llobregat
• Madrid
• Valencia

Sweden

• Goeteborg

United Kingdom

• Liverpool
• London

United States

• Little Rock, AR
• Los Angeles, CA
• Hartford, CT
• Augusta, GA
• Chicago, IL
• Louisville, KY
• Hackensack, NJ
• Livingston, NJ
• Durham, NC
• Cincinnati, OH
• Cleveland, OH
• Oklahoma City, OK
• Pittsburgh, PA
• Houston, TX