NCT04131322

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Crohn Disease
• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Amgevita 40Mg Solution for Injection	Adalimumab 40Mg Solution for Injection
DRUG	HUMIRA 40Mg Solution for Injection	Adalimumab 40Mg Solution for Injection

Timeline

• Start date: 2019-10-10
• Primary completion: 2020-06-08
• Completion: 2020-06-08
• First posted: 2019-10-18
• Last updated: 2021-01-12

Locations

1 site across 1 country: Spain