A 12-WEEK RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, 2-ARM STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TOCILIZUMAB IN PATIENTS WITH ACTIVE SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA); WITH A 92-WEEK SINGLE ARM OPEN-LABEL EXTENSION TO EXAMINE THE LONG TERM USE OF TOCILIZUMAB - ND

• Conditions: Systemic Juvenile Idiopathic Arthritis (sJIA); MedDRA version: 9.1Level: LLTClassification code 10059177Term: Juvenile arthritis

• Registration Number: EUCTR2007-000872-18-IT
• Lead Sponsor: ROCHE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-23
• Last Update Posted: 14 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. Age 2 up to and including 17 years at screening into trial; 2. Systemic Juvenile Idiopathic Arthritis according to ILAR classification (2001); 3. More than 6 months of persistent sJIA activity prior to screening including an inadequate response to NSAIDs and corticosteroids due to toxicity or lack of efficacy. 4. Presence of active disease as determined by the presence of : > 5 active joints, or > 2 active joints and fever >38C for at least 5 out of any 14 consecutive days during screening and receiving prednisone or equivalent at a stable dose at nomore than 0.5 mg/kg/day or 30 mg/day, whichever is less. During this same time period the corticosteroid dose continues unchanged. 5. hsCRP > 4.3 mg/L or 0.43 mg/dl (1.5 x ULN (ULN= 0.28 mg/dl)); 6. Recovered from any symptomatic serositis for at least one month prior to the screening visit, and requiring dose of corticosteroids < than 30 mg/day at baseline 7. Fertility: Female not of child-bearing potential, or Female of child-bearing potential practicing effective contraceptive measures, having a negative urine pregnancy test within three weeks prior to randomization; or Sterile male, or Non sterile male practicing effective contraceptive measures with female partner of child-bearing potential. [Females of childbearing potential must be using a reliable means of contraception (abstinence being a possible option) throughout the study and up to 12 weeks after the last infusion of study drug]. Etc.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

General Exclusion Criteria 1. Wheelchair or bedridden; 2. Any other auto-immune, rheumatic disease or overlap syndrome other than sJIA; 3. Not fully recovered from recent surgery or less than six weeks since surgery, at the time of screening visit; or planned surgery during the initial 12 weeks of the study; 4. Lack of peripheral venous access; Other Exclusion criteria regarding - General Safety - Previous or Concomitant Therapy - Laboratory Exclusions

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified