Ignite Creation Date:
2024-05-06 @ 1:48 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04131322
Status:
TERMINATED
Last Update Posted:
2021-01-12
First Post:
2019-10-10
Brief Title:
Loss of Response of Adalimumab Biosimilar vs Adalimumab Original in Inflammatory Bowel Disease
Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Organization:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor cancellation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADA-SWITCH
Brief 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 Crohns 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 11 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 products approved label by SmPC Summary of Products Characteristicsby technical file Administration will be accepted every 7 days if the patient after inclusion criteria is included with intensified dose
A total of 216 patients with inflammatory bowel disease from the Inflammatory Unit of the Virgin Macarena University Hospital will be randomized 11 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 products approved label by SmPC Summary of Products Characteristicsby technical file Administration will be accepted every 7 days if the patient after inclusion criteria is included with intensified dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None