Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease. (ADA-SWITCH)
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|ClinicalTrials.gov Identifier: NCT04131322|
Recruitment Status : Not yet recruiting
First Posted : October 18, 2019
Last Update Posted : October 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease Ulcerative Colitis||Drug: Amgevita 40Mg Solution for Injection Drug: HUMIRA 40Mg Solution for Injection||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||216 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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"|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||January 2021|
Drug: Amgevita 40Mg Solution for Injection
Adalimumab 40Mg Solution for Injection
Other Name: AMGEVITA
Active Comparator: non-switchcohort
Drug: HUMIRA 40Mg Solution for Injection
Adalimumab 40Mg Solution for Injection
Other Name: HUMIRA
- Change from baseline to final follow-up in the response of the switch. [ Time Frame: From date of randomization until the date of first documented change from baseline status in concomitant steroids needed or increment in dose or frequency of adalimumab biosimilar or urgent surgery indication ever came first, assessed up to 13 months ]To assess if there is a change in the response of the switch (replacement) from Adalimumab original (Humira®) to Adalimumab biosimilar (Amgevita®) trhough the quantification of concomitant steroids needed or increment in dose or frequency of adalimumab biosimilar or urgent surgery indication
- Compare the antibody formation rate. [ Time Frame: 0, 3, 6, 9, 12, 13 months ]Compare the antibody formation rate with Adalimumab(immunogenicity) after the switch.
- The score of the specific quality of life questionnaire [ Time Frame: 0, 3, 6, 9, 12, 13 months ]Compare the score of the specific quality of life questionnaire Short Inflammatory Bowel Disease Questionnaire (SIBDQ) in patients with inflammatory bowel disease before and after the switch.The minimum value is 1 and the maximum is 7, where higher scores means better outcome.
- The score of the Visual Analogue Scale (VAS) [ Time Frame: 0, 3, 6, 9, 12, 13 months ]Compare the score of the Visual Analogue Scale (VAS) of pain at the puncture site after the switch. The minimum value is 0 mm and the maximum value is 100 mm, where the higher score means a worse outcome.
- Maintenance of bioquimical remission trhough C-reactive protein [ Time Frame: 0, 3, 6, 9, 12, 13 months ]levels of C-reactive protein in blood (mg/L).
- Maintenance of bioquimical remission through Calprotectin values [ Time Frame: 0, 3, 6, 9, 12, 13 months ]levels of Calprotectin in blood (µg/g).
- Drug levels [ Time Frame: 0, 3, 6, 9, 12, 13 months ]Determination of drug levels in blood (µg/ml).
- Adverse Event [ Time Frame: 0, 3, 6, 9, 12, 13 months ]Proportion of patients who experience AE in each treatment group
- Hospital admission rate [ Time Frame: 0, 3, 6, 9, 12, 13 months ]Proportion of patients requiring hospital admissions related to a disease outbreak during follow-up.
- Surgery rate [ Time Frame: 0, 3, 6, 9, 12, 13 months ]Proportion of patients requiring surgery related to disease activity during follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04131322
|Contact: Federico Rosso Fernandez, Md PhD||0034 firstname.lastname@example.org|
|Contact: Federico Argüelles Arias, Md PhD||0034 email@example.com|
|Principal Investigator:||Federico Argüelles Arias, Md PhD||Universitary Hospital Virgen Macarena|