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Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease. — ADA-SWITCH  

Ulcerative Colitis Clinical Trial

Official title:
Loss of Response of Adalimumab Biosimilar Compared With the Loss of Response of Adalimumab Original: Controlled, Randomized, Non-inferiority Open Study. "ADA-SWITCH Study"

Clinical Trial Summary

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

Clinical Trial Description

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04131322
Study type Interventional
Source Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Contact
Status Terminated
Phase Phase 4
Start date October 10, 2019
Completion date June 8, 2020
View Details
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