Description:

Extension Study Evaluating the Safety and Efficacy of Subcutaneous RoActemra/Actemra Administration in Patients With Systemic and Polyarticular-Course Juvenile Idiopathic Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02165345

Link:

https://clinicaltrials.gov/show/NCT02165345

Keywords:
Versions (1) ▾
  1. 4/30/20
Copyright Holder:
See clinicaltrials.gov
Uploaded on:

April 30, 2020

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License:
Creative Commons BY 4.0
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Eligibility Juvenile Idiopathic Arthritis NCT02165345

Eligibility Juvenile Idiopathic Arthritis NCT02165345

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 patient's parents or guardian, with assent as appropriate by the patient, depending on the level of the patient's understanding
for patients of reproductive potential: use of effective contraception as defined by the study protocol
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 patient's 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