Polyarticular-course juvenile idiopathic arthritis MedDRA version: 14.1 Level: LLT Classification code 10059176 Term: Juvenile idiopathic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: RoActemra
Product Name: Ro-Actemra
Product Code: RO4877533
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Spons
Sponsors
Roche Pharma AG
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients– age 9 to 18- who completed visit 33 (week 104) of WA19977 study with at least JIA ACR30 clinical response to tocilizumab relative to baseline in WA19977 study with no AEs, SAEs or conditions that lead to unacceptable risk of continued treatment. 2. Patients should be scheduled to receive the first tocilizumab infusion in this study between 4 and 6 weeks after the last IV infusion in the core study (WA19977). 3. Written informed consent for study participation obtained from: - Patient if the patient is 18 years or older - Parents or legal guardian, with assent as appropriate by the patient, depending on the level of the patients understanding for patients that are less than 18 years old In addition, written consent for data protection (legal requirement in Germany: datenschutz-rechtliche Einwilligung) must be provided. 4. Patient and parents or legal guardian able and willing to comply with the requirements of the extension study protocol. 5. If female and of child-bearing potential, the patient must have a negative urine pregnancy test at day 0 before infusion takes place. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. According to investigator judgment patient did not satisfactory benefit from tocilizumab therapy within WA19977. 2. Treatment with any investigational agent since the last administration of study drug in the core study WA19977 or patients who participate currently in another clinical trial except WA19977. 3. Patient developed any other auto-immune, rheumatic disease or overlap syndrome other than the permitted polyarticular-course JIA subsets: Rheumatoid Factor Positive polyarticular JIA, Rheumatoid Factor Negative polyarticular JIA, and extended oligoarticular JIA. The excluded illnesses include but are not limited to systemic juvenile idiopathic arthritis, Lyme disease, enthesitis-related arthritis, psoriatic arthritis, Reiter´s syndrome, systemic lupus erythematosus, infectious or reactive arthritis or parvovirus infections. 4. Lack of peripheral venous access or unwilling to undergo multiple venopunctures. 5. Lack of patient´s or parents cooperation. 6. Any other reasons which in investigator´s opinion limit the possibility of patient´s participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long term safety of tocilizumab treatment in patients with pcJIA from Germany who entered this extension.;Secondary Objective: To investigate the long term efficacy during treatment with tocilizumab in patients with pcJIA from Germany who entered this extension study.;Primary end point(s): Safety Number and percentage of AEs, SAEs, AE of Special Interest, Study Drug Related AEs;Timepoint(s) of evaluation of this end point: Screen/BL; every 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy Proportion of patients with JIA ACR30/50/70/90 Proportion of patients with inactive disease at visits;Timepoint(s) of evaluation of this end point: Screen/BL; every 12 weeks | — |
Countries
Germany
Contacts
Public ContactCountry Study Manager
Roche Pharma AG
Outcome results
None listed