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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Adalimumab 40Mg Solution for Injection
Adalimumab 40Mg Solution for Injection
Hospital Universitario Virgen Macarena
Seville, Spain
Change from baseline to final follow-up in the response of the switch.
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
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
Compare the antibody formation rate.
Compare the antibody formation rate with Adalimumab(immunogenicity) after the switch.
Time frame: 0, 3, 6, 9, 12, 13 months
The score of the specific quality of life questionnaire
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.
Time frame: 0, 3, 6, 9, 12, 13 months
The score of the Visual Analogue Scale (VAS)
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.
Time frame: 0, 3, 6, 9, 12, 13 months
Maintenance of bioquimical remission trhough C-reactive protein
levels of C-reactive protein in blood (mg/L).
Time frame: 0, 3, 6, 9, 12, 13 months
Maintenance of bioquimical remission through Calprotectin values
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levels of Calprotectin in blood (µg/g).
Time frame: 0, 3, 6, 9, 12, 13 months
Drug levels
Determination of drug levels in blood (µg/ml).
Time frame: 0, 3, 6, 9, 12, 13 months
Adverse Event
Proportion of patients who experience AE in each treatment group
Time frame: 0, 3, 6, 9, 12, 13 months
Hospital admission rate
Proportion of patients requiring hospital admissions related to a disease outbreak during follow-up.
Time frame: 0, 3, 6, 9, 12, 13 months
Surgery rate
Proportion of patients requiring surgery related to disease activity during follow-up.
Time frame: 0, 3, 6, 9, 12, 13 months