LOSS OF RESPONSE OF THE ADALIMUMAB BIOSIMILAR COMPARED WITH THE LOSS OF RESPONSE OF THE ADALIMUMAB ORIGINAL: CONTROLLED, RANDOMIZED, NON-INFERIORITY OPEN STUDY.

INTERVENTION: Trade Name: AMGEVITA® Product Name: AMGEVITA (Adalimumab biosimilar ) Pharmaceutical Form: Solution for injection Trade Name: HUMIRA ® Product Name: Humira (adalimumab original) Pharmaceutical Form: Solution for injection CONDITION: Inflammatory Bowel Disease: Crohn's Disease and Ulcerative Colitis Therapeutic area: Diseases [C] ‐ Digestive System Diseases [C06] PRIMARY OUTCOME: ; Secondary Objective: ‐ Compare the safety of the Adalimumab original switch (Humira®) to Adalimumab biosimilar (Amgevita®) vs the maintenance of the original medication in patients with inflammatory bowel disease.; ‐ Compare the antibody formation rate with Adalimumab(immunogenicity) after the switch.; ‐ Compare the score of the specific quality of life questionnaire in patients with inflammatory bowel disease (IBDQ‐9) before and after the switch.; ‐ Compare the score of the visual analogue scale (VAS) of pain at the puncture site after the switch.; ‐ Determine prognostic factors for the maintenance of biochemical remission (C‐reactive protein, calprotectin), and drug (drug levels, formation of antibodies against ADA drug).; Main Objective: To compare the loss of response of the switch (replacement) from Adalimumab original (Humira®) to Adalimumab biosimilar (Amgevita®) vs the maintenance of the Adalimumab original in patients with inflammatory bowel disease. Primary end point(s): Loss of response: measured as the proportion of patients with a loss of response at twelve months (adalimumab original vs adalimumab biosimilar) Timepoint(s) of evaluation of this end point: 12‐months SECONDARY OUTCOME: ; Secondary end point(s): Loss of response:; ‐ Proportion of patients who need treatment intensification; ‐ Proportion of patients who need corticosteroids; ‐ Proportion of patients who need to change biological due to loss of response; ‐ Proportion of patients with changes in the quality of life index (IBDQ‐9) after the switch.; ‐ Proportion of patients presenting a higher score on the analogous scale of pain after the drug switch.; ; Immunogenicity; Immunogenicity rate: measured as the proportion of patients that generate anti‐ drug antibodies after the switch; ; Safety; ‐ Rate of adverse events: measured as the proportion of adverse events during the clinical study. (all types of adverse events will be reported, and they will be graduated according to their severity and will collected in CRF); ‐ Hospital admission rate measured as the proportion of patients requiring hospital admissions related to a disease outbreak during follow‐up.; ‐ Surgery rate: measured as the proportion of patients requiring surgery related to disease activity during follow‐up.; ; Timepoint(s) of evaluation of this end point: loss of response : 12 months; Safety : 16 months; INCLUSION CRITERIA: ‐ Be male or female over 18 years of age ‐ Be a Patient with a previous confirmed diagnosis of Crohn´s disease an Ulcerative Colitis ‐ Previous treated with original Adalimumab for at least 6 months with regular maintenance dose (40 mg every 15 days) and in clinical and biological remission. ‐ Patients under treatment with intensified Adalimumab (40mg every 7 days or 80mg every 7 days) to maintain clinical and biological remission for at least 6 months. ‐ Patients with oral mesalazine with a stable dose for more than 30 days. ‐ Patients with immunosuppressive therapy (methotrexate, azathioprine) with a minimum intake time> 60 days. ‐ Patients may be accepted with corticosteroids at the established doses: prednisone <20mg / dl, budesonide <9mg / dl. ‐ Patients who have a tuberculosis (TB) study (Mantoux / QuantiFE