Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease. (ADA-SWITCH)

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status and phase

Terminated

Phase 4

Conditions

Ulcerative Colitis

Crohn Disease

Treatments

Drug: HUMIRA 40Mg Solution for Injection

Drug: Amgevita 40Mg Solution for Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT04131322

AMGEVITA-HVM2019

Details and patient eligibility

About

Loss of response of the Adalimumab biosimilar compared with the original drug.

Full description

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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 / QuantiFERONTB test) updated in the last two year, with a negative result.
Patient with serology hepatitis B and C, updated at the beginning of the treatment with Humira®
Sign an informed consent document indicating that he/she understands the purpose of, and procedures required for, the study and are willing to participate in the study.

Exclusion criteria

Positive pregnancy test at the time of inclusion or during the follow-up period, as well as women who are breastfeeding
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 <60 days.
Patient with original Adalimumab who do not meet a minimum of 6 months of stable dose (40 mg every 7 or 15 days)
Patient on corticosteroid therapy at doses: prednisone> 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)