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

January 11, 2021 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Loss of Response of Adalimumab Biosimilar Compared With the Loss of Response of Adalimumab Original: Controlled, Randomized, Non-inferiority Open Study. "ADA-SWITCH Study"

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: switch-cohort
Adalimumab biosimilar
Drug: Amgevita 40Mg Solution for Injection
Adalimumab 40Mg Solution for Injection
Other Names:
  • AMGEVITA
ACTIVE_COMPARATOR: non-switchcohort
Adalimumab original
Drug: HUMIRA 40Mg Solution for Injection
Adalimumab 40Mg Solution for Injection
Other Names:
  • HUMIRA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline to final follow-up in the response of the switch.
Time Frame: 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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Compare the antibody formation rate.
Time Frame: 0, 3, 6, 9, 12, 13 months
Compare the antibody formation rate with Adalimumab(immunogenicity) after the switch.
0, 3, 6, 9, 12, 13 months
The score of the specific quality of life questionnaire
Time Frame: 0, 3, 6, 9, 12, 13 months
Compare the score of the specific quality of life questionnaire Short Inflammatory Bowel Disease Questionnaire (SIBDQ) in patients with inflammatory bowel disease before and after the switch.The minimum value is 1 and the maximum is 7, where higher scores means better outcome.
0, 3, 6, 9, 12, 13 months
The score of the Visual Analogue Scale (VAS)
Time Frame: 0, 3, 6, 9, 12, 13 months
Compare the score of the Visual Analogue Scale (VAS) of pain at the puncture site after the switch. The minimum value is 0 mm and the maximum value is 100 mm, where the higher score means a worse outcome.
0, 3, 6, 9, 12, 13 months
Maintenance of bioquimical remission trhough C-reactive protein
Time Frame: 0, 3, 6, 9, 12, 13 months
levels of C-reactive protein in blood (mg/L).
0, 3, 6, 9, 12, 13 months
Maintenance of bioquimical remission through Calprotectin values
Time Frame: 0, 3, 6, 9, 12, 13 months
levels of Calprotectin in blood (µg/g).
0, 3, 6, 9, 12, 13 months
Drug levels
Time Frame: 0, 3, 6, 9, 12, 13 months
Determination of drug levels in blood (µg/ml).
0, 3, 6, 9, 12, 13 months
Adverse Event
Time Frame: 0, 3, 6, 9, 12, 13 months
Proportion of patients who experience AE in each treatment group
0, 3, 6, 9, 12, 13 months
Hospital admission rate
Time Frame: 0, 3, 6, 9, 12, 13 months
Proportion of patients requiring hospital admissions related to a disease outbreak during follow-up.
0, 3, 6, 9, 12, 13 months
Surgery rate
Time Frame: 0, 3, 6, 9, 12, 13 months
Proportion of patients requiring surgery related to disease activity during follow-up.
0, 3, 6, 9, 12, 13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Federico Argüelles Arias, Md PhD, Universitary Hospital Virgen Macarena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 8, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 8, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AMGEVITA-HVM2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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