Description:

A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis From France Who Completed WA19977 Core Study; ODM derived from: https://clinicaltrials.gov/show/NCT01673919

Link:

https://clinicaltrials.gov/show/NCT01673919

Keywords:
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  1. 4/29/20
Copyright Holder:
See clinicaltrials.gov
Uploaded on:

April 29, 2020

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License:
Creative Commons BY 4.0
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Eligibility Juvenile Idiopathic Arthritis NCT01673919

Eligibility Juvenile Idiopathic Arthritis NCT01673919

Inclusion Criteria
patients who completed visit 33 (week 104) of wa19977 study and who may benefit from study drug treatment according to the investigator's assessment
patients have to receive the first roactemra/actemra infusion in this study at the week 8 visit at the latest
females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol
Exclusion Criteria
patients with, according to investigator judgment, not satisfactory benefit from roactemra/actemra therapy within wa19977
treatment with any investigational agent since the last administration of study drug in the core study wa19977
patient developed any other autoimmune rheumatic disease or overlap syndrome other than the permitted polyarticular-course jia subsets: rheumatoid factor positive or negative jia or extended oligoarticular jia
patient is pregnant , lactating, or intending to become pregnant during the study and up to 12 weeks after the last administration of study drug
any significant concomitant disease or medical or surgical condition
history of significant allergic or infusion reactions to prior biologic therapy
currently active primary or secondary immunodeficiency
any infections with contraindications to roactemra/actemra therapy according to investigator judgment
inadequate hepatic, renal or bone marrow function