ong Term Study to Evaluate the Safety and Benefit of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic Arthritis
- Conditions
- Polyarticular-course juvenile idiopathic arthritis (pJIA)Systemic juvenile idiopathic arthritis (sJIA)MedDRA version: 20.0Level: PTClassification code 10059176Term: Juvenile idiopathic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2013-005212-98-DE
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 104
- 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 TCZ , as assessed by the investigator
- Written informed consent for study participation obtained from the patient (for patients >/= 18 years old) or the patient's parents or guardian, with assent as appropriate by the patient, depending on the level of the patient's understanding
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of TCZ
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm during the treatment period and for at least 6 months after the last dose of TCZ
Are the trial subjects under 18? yes
Number of subjects for this age range: 104
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
- Prior discontinuation of intravenous (IV) TCZ because of inadequate clinical response or safety events (including hypersensitivity)
- Therapy with biologic agents (except TCZ) in the period between completion of the JIGSAW study and screening for the current study
- Concurrent treatment with disease-modifying anti-rheumatic drugs (including methotrexate ), nonsteroidal anti-inflammatory drugs, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the long-term safety of subcutaneous (SC) administration of tocilizumab (TCZ) in patients with pJIA and sJIA for up to 5 years<br>To describe the long-term efficacy of SC TCZ in patients with pJIA and sJIA for up to 3 years<br><br>;Secondary Objective: Not applicable<br><br>;Primary end point(s): - Incidence of adverse events<br>- Incidence of serious adverse events<br>- Incidence of adverse events of special interest<br>- Incidence of clinical laboratory abnormalities <br>- Juvenile Arthritis Disease Activity Score (JADAS-71)<br>- Childhood Health Assessment Questionnaire (CHAQ) score<br>- Inactive disease/clinical remission;Timepoint(s) of evaluation of this end point: 1-4. Up to 5 years<br>5-7. Up to 3 years<br><br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable