Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease.

NCT ID: NCT04131322

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-10
• Study Completion Date: 2020-06-08

Brief Summary

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

Detailed 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.

Conditions

Crohn Disease; Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

switch-cohort

Adalimumab biosimilar

Group Type: EXPERIMENTAL

Amgevita 40Mg Solution for Injection

Intervention Type: DRUG

Adalimumab 40Mg Solution for Injection

non-switchcohort

Adalimumab original

Group Type: ACTIVE_COMPARATOR

HUMIRA 40Mg Solution for Injection

Intervention Type: DRUG

Adalimumab 40Mg Solution for Injection

Interventions

Amgevita 40Mg Solution for Injection

Adalimumab 40Mg Solution for Injection

Intervention Type: DRUG

HUMIRA 40Mg Solution for Injection

Adalimumab 40Mg Solution for Injection

Intervention Type: DRUG

Other Intervention Names

AMGEVITA; HUMIRA

Eligibility 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 <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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Federico Argüelles Arias, Md PhD

Role: PRINCIPAL_INVESTIGATOR

Universitary Hospital Virgen Macarena

Locations

Hospital Universitario Virgen Macarena

Seville, , Spain

Countries

Spain

Other Identifiers

AMGEVITA-HVM2019

Identifier Type: -

Identifier Source: org_study_id