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Clinical Trials/EUCTR2013-005212-98-ES
EUCTR2013-005212-98-ESActive, not recruitingPhase 1

ONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS

Roche Farma S.A. en nombre de F. Hoffmann-La Roche Ltd0 sites82 target enrollmentStarted: June 9, 2014Last updated:
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Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
82
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •- Completion of either of the JIGSAW studies, study WA28117 (for patients with pcJIA) or study WA28118 (for patients with sJIA)
  • •- Adequate disease control with the use of SC RoActemra/Actemra, as assessed by the investigator
  • •- Written informed consent for study participation obtained from the patient (for patients >/= 18 years old) or the patients parents or guardian, with assent as appropriate by the patient, depending on the level of the patients understanding
  • •- For patients of reproductive potential: use of effective contraception as defined by the study protocol
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 96
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number of subjects for this age range 0
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

  • •- Therapy with biologic agents (except RoActemra/Actemra) in the period between completion of the JIGSAW study and screening for the current study
  • •- Concurrent treatment with DMARDs (including MTX), NSAIDs, and oral corticosteroids is permitted at the discretion of the investigator
  • •- Use of live or attenuated vaccines and immunosuppressants, such as cyclosporine and cyclophosphamide, is prohibited
  • •- Pregnancy or breast-feeding
  • •- Any significant concurrent medical or surgical conditions or findings that would jeopardize the patients safety or ability to complete the study, including but not limited to disease of the nervous, renal, hepatic, cardiac, pulmonary, gastric, or endocrine system or any infection
  • •- History of alcohol, drug, or chemical abuse within 6 months prior to screening
  • •- History of atypical tuberculosis (TB) or active TB requiring treatment within 2 years prior to screening

Investigators

Sponsor
Roche Farma S.A. en nombre de F. Hoffmann-La Roche Ltd

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