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

NCT04131322 | Terminated Phase 4

• 1 other identifier: AMGEVITA-HVM2019
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Crohn Disease; Ulcerative Colitis

Keywords

Loss of response; Switching; Adalimumab original; Adalimumab biosimilar

Outcome Measures

Primary Outcomes (1)

• 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

  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

Secondary Outcomes (9)

• Compare the antibody formation rate.

  0, 3, 6, 9, 12, 13 months

• The score of the specific quality of life questionnaire

  0, 3, 6, 9, 12, 13 months

• The score of the Visual Analogue Scale (VAS)

  0, 3, 6, 9, 12, 13 months

• Maintenance of bioquimical remission trhough C-reactive protein

  0, 3, 6, 9, 12, 13 months

• Maintenance of bioquimical remission through Calprotectin values

  0, 3, 6, 9, 12, 13 months

Study Arms (2)

switch-cohort

EXPERIMENTAL

Adalimumab biosimilar

Drug: Amgevita 40Mg Solution for Injection

non-switchcohort

ACTIVE COMPARATOR

Adalimumab original

Drug: HUMIRA 40Mg Solution for Injection

Interventions

Amgevita 40Mg Solution for Injection DRUG

Adalimumab 40Mg Solution for Injection

Also known as: AMGEVITA

switch-cohort

HUMIRA 40Mg Solution for Injection DRUG

Adalimumab 40Mg Solution for Injection

Also known as: HUMIRA

non-switchcohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Interventions

Solutions; Injections; Adalimumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Federico Argüelles Arias, Md PhD

  Universitary Hospital Virgen Macarena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 18, 2019
• Study Start: October 10, 2019
• Primary Completion: June 8, 2020
• Study Completion: June 8, 2020
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)