ong term study to evaluate the safety and benefit of subcutaneous RoActemra/Actemra in the treatment of Juvenile Idiopathic Arthritis patients.

Phase 1

Conditions: Polyarticular-course juvenile idiopathic arthritis (pcJIA)
Systemic juvenile idiopathic arthritis (sJIA)
MedDRA version: 17.0Level: PTClassification code 10059176Term: Juvenile idiopathic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2013-005212-98-IT

Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 96

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

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 SC administration of TCZ in patients with pcJIA and sJIA<br>To describe the long-term efficacy of SC TCZ in patients with pcJIA and sJIA<br><br>;Secondary Objective: Exploratory objectives:<br>To assess long-term pharmacodynamics of SC TCZ in patients with pcJIA and sJIA<br>To assess long-term pharmacokinetics of SC TCZ in patients with pcJIA and sJIA<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>Change in Juvenile Arthritis Disease Activity Score (JADAS-71)<br>Change in Childhood Health Assessment Questionnaire (CHAQ) score<br>Inactive disease/clinical remission;Timepoint(s) of evaluation of this end point: Up to 3 years<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The exploratory PK outcome measures will be trough TCZ plasma concentrations measured at specified time-points, and those for PD include Soluble IL-6R (sIL-6R) levels, CRP, ESR , and incidence of anti-TCZ antibodies.;Timepoint(s) of evaluation of this end point: Up to 3 years<br>

Related Trials