Loss of response of the Adalimumba biosimilar compared with the original drug

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000717-37-ES

Enrollment

136

Registered

2019-06-28

Start date

2019-06-27

Completion date

Unknown

Last updated

2021-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease: Crohn's Disease and Ulcerative Colitis

Interventions

Trade Name: AMGEVITA® Product Name: AMGEVITA (Adalimumab biosimilar ) Pharmaceutical Form: Solution for injection Trade Name: HUMIRA ® Product Name: Humira (adalimumab original) Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: -Pregnant or nursing women - Patients with uncontrolled comorbidities, active cancer, diabetes mellitus, severe cardiovascular disease, obstructive pulmonary disease, serious active infections. - Patients with oral mesalazine initiated less than 30 days. - Patients with immunosuppressive therapy (methotrexate, azathioprine) with a minimum intake time of 20mg / dl, budesonide = 9mg / dl, or with IV corticoids within 14 days prior screening date. - Patients with mental disorders, alcohol / other substance abuse, or conditions that do not allow adherence to the study protocol. - Patients with active TB - Patients with defined Hepatitis B and C defined as: HBV: hepatitis B surface antigen (HbsAg) positive together with positive HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR). HCV: HCV ribonucleic acid (RNA) detectable in any patient with positive anti-HCV antibody (IgG)

Design outcomes

Primary

Measure	Time frame
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.;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).;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	—

Measure

Time frame

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.;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).;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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Spain

Contacts

Public ContactUICEC-HUVR

Unidad de Investigación Clínica y Ensayos Clínicos

claram.rosso.sspa@juntadeandalucia.es0034955012144

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026