Back to resultsLoss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease. (ADA-SWITCH)
Primary Purpose
Crohn Disease, Ulcerative Colitis
Status
Terminated
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Amgevita 40Mg Solution for Injection
HUMIRA 40Mg Solution for Injection
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease focused on measuring Loss of response, Switching, Adalimumab original, Adalimumab biosimilar
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)
Sites / Locations
- Hospital Universitario Virgen Macarena
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
switch-cohort
non-switchcohort
Arm Description
Adalimumab biosimilar
Adalimumab original
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Compare the antibody formation rate.
Compare the antibody formation rate with Adalimumab(immunogenicity) after the switch.
The score of the specific quality of life questionnaire
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.
The score of the Visual Analogue Scale (VAS)
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.
Maintenance of bioquimical remission trhough C-reactive protein
levels of C-reactive protein in blood (mg/L).
Maintenance of bioquimical remission through Calprotectin values
levels of Calprotectin in blood (µg/g).
Drug levels
Determination of drug levels in blood (µg/ml).
Adverse Event
Proportion of patients who experience AE in each treatment group
Hospital admission rate
Proportion of patients requiring hospital admissions related to a disease outbreak during follow-up.
Surgery rate
Proportion of patients requiring surgery related to disease activity during follow-up.
Full Information
NCT ID
NCT04131322
First Posted
October 10, 2019
Last Updated
January 11, 2021
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
1. Study Identification
Unique Protocol Identification Number
NCT04131322
Brief Title
Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease.
Acronym
ADA-SWITCH
Official Title
Loss of Response of Adalimumab Biosimilar Compared With the Loss of Response of Adalimumab Original: Controlled, Randomized, Non-inferiority Open Study. "ADA-SWITCH Study"
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor cancellation
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
June 8, 2020 (Actual)
Study Completion Date
June 8, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Ulcerative Colitis
Keywords
Loss of response, Switching, Adalimumab original, Adalimumab biosimilar
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
switch-cohort
Arm Type
Experimental
Arm Description
Adalimumab biosimilar
Arm Title
non-switchcohort
Arm Type
Active Comparator
Arm Description
Adalimumab original
Intervention Type
Drug
Intervention Name(s)
Amgevita 40Mg Solution for Injection
Other Intervention Name(s)
AMGEVITA
Intervention Description
Adalimumab 40Mg Solution for Injection
Intervention Type
Drug
Intervention Name(s)
HUMIRA 40Mg Solution for Injection
Other Intervention Name(s)
HUMIRA
Intervention Description
Adalimumab 40Mg Solution for Injection
Primary Outcome Measure Information:
Title
Change from baseline to final follow-up in the response of the switch.
Description
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
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
Secondary Outcome Measure Information:
Title
Compare the antibody formation rate.
Description
Compare the antibody formation rate with Adalimumab(immunogenicity) after the switch.
Time Frame
0, 3, 6, 9, 12, 13 months
Title
The score of the specific quality of life questionnaire
Description
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.
Time Frame
0, 3, 6, 9, 12, 13 months
Title
The score of the Visual Analogue Scale (VAS)
Description
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.
Time Frame
0, 3, 6, 9, 12, 13 months
Title
Maintenance of bioquimical remission trhough C-reactive protein
Description
levels of C-reactive protein in blood (mg/L).
Time Frame
0, 3, 6, 9, 12, 13 months
Title
Maintenance of bioquimical remission through Calprotectin values
Description
levels of Calprotectin in blood (µg/g).
Time Frame
0, 3, 6, 9, 12, 13 months
Title
Drug levels
Description
Determination of drug levels in blood (µg/ml).
Time Frame
0, 3, 6, 9, 12, 13 months
Title
Adverse Event
Description
Proportion of patients who experience AE in each treatment group
Time Frame
0, 3, 6, 9, 12, 13 months
Title
Hospital admission rate
Description
Proportion of patients requiring hospital admissions related to a disease outbreak during follow-up.
Time Frame
0, 3, 6, 9, 12, 13 months
Title
Surgery rate
Description
Proportion of patients requiring surgery related to disease activity during follow-up.
Time Frame
0, 3, 6, 9, 12, 13 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Federico Argüelles Arias, Md PhD
Organizational Affiliation
Universitary Hospital Virgen Macarena
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease.
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