Date: 2016-08-15
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Boehringer Ingelheim (Germany)
Product: BI 695501 (biosimilar version of Humira® (adalimumab))
Action mechanism: biosimilar/monoclonal antibody/TNF alpha inhibitor
Disease: Crohn's disease
Therapeutic area: Autoimmune diseases - Inflammatory diseases - Digestive diseases
Country:
Trial details: The primary objective of this trial is to compare the clinical efficacy of BI 695501 with EU-approved Humira® in patients with active Crohn's disease (CD). The secondary objectives of this trial are to compare the efficacy and safety of BI 695501 with EU-approved Humira® across the induction and maintenance phases. (NCT02871635)
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