Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease.

2019-10-24 12:49:52 | BioPortfolio


Loss of response of the Adalimumab biosimilar compared with the original drug.


A single-site Unicentric, randomized, parallel-group, non-inferiority open study including patients diagnosed with inflammatory bowel disease (Crohn's disease and Ulcerative Colitis) who were in clinical remission with Adalimumab original for at least 6 months prior to the start of the study.

A total of 216 patients with inflammatory bowel disease from the Inflammatory Unit of the Virgin Macarena University Hospital will be randomized 1:1 to receive the study drug, Adalimumab biosimilar (AMGEVITA®) subcutaneous 40mg every 15 days or maintain the original drug (Humira®) 40 mg subcutaneous every 15 days.

The dosage of the medication will be administrated according to the product's approved label by SmPC (Summary of Product's Characteristics)by technical file. Administration will be accepted every 7 days, if the patient after inclusion criteria is included with intensified dose.

Study Design


Crohn Disease


Amgevita 40Mg Solution for Injection, HUMIRA 40Mg Solution for Injection


Not yet recruiting


Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Results (where available)

View Results


Published on BioPortfolio: 2019-10-24T12:49:52-0400

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