Crohn DiseasePhase 4ADA-SWITCHNCT04131322
Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease.
A Phase 4 study testing Amgevita 40Mg Solution for Injection and HUMIRA 40Mg Solution for Injection in people with Crohn Disease and Ulcerative Colitis, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial summary
Loss of response of the Adalimumab biosimilar compared with the original drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis
- What is being tested?
- Amgevita 40Mg Solution for Injection and HUMIRA 40Mg Solution for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 10 Oct 2019to 8 Jun 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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"
Loss of response of the Adalimumab biosimilar compared with the original drug.
Read the 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
- Being tested
- Amgevita 40Mg Solution for Injection, HUMIRA 40Mg Solution for Injection
- Keywords
- Loss of response, Switching, Adalimumab original, Adalimumab biosimilar
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amgevita 40Mg Solution for InjectionDrug
Also called AMGEVITA
Adalimumab 40Mg Solution for Injection
HUMIRA 40Mg Solution for InjectionDrug
Also called HUMIRA
Adalimumab 40Mg Solution for Injection
| Study group | Role | What they receive |
|---|---|---|
| switch-cohort | Experimental | Adalimumab biosimilar Receives: Drug: Amgevita 40Mg Solution for Injection |
| non-switchcohort | Active comparator | Adalimumab original Receives: Drug: HUMIRA 40Mg Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Compare the antibody formation rate with Adalimumab(immunogenicity) after the switch.
Measured: 0, 3, 6, 9, 12, 13 months
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.
Measured: 0, 3, 6, 9, 12, 13 months
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.
Measured: 0, 3, 6, 9, 12, 13 months
Maintenance of bioquimical remission trhough C-reactive protein
levels of C-reactive protein in blood (mg/L).
Measured: 0, 3, 6, 9, 12, 13 months
Maintenance of bioquimical remission through Calprotectin values
levels of Calprotectin in blood (µg/g).
Measured: 0, 3, 6, 9, 12, 13 months
Drug levels
Determination of drug levels in blood (µg/ml).
Measured: 0, 3, 6, 9, 12, 13 months
Adverse Event
Proportion of patients who experience AE in each treatment group
Measured: 0, 3, 6, 9, 12, 13 months
Hospital admission rate
Proportion of patients requiring hospital admissions related to a disease outbreak during follow-up.
Measured: 0, 3, 6, 9, 12, 13 months
Surgery rate
Proportion of patients requiring surgery related to disease activity during follow-up.
Measured: 0, 3, 6, 9, 12, 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start10 Oct 2019
- Primary completion8 Jun 2020
- Study completion8 Jun 2020
Why it stopped: Sponsor cancellation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Federico Argüelles Arias, Md PhD, Principal investigator, Universitary Hospital Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131322
- Sponsor's protocol ID
- AMGEVITA-HVM2019
- Acronym
- ADA-SWITCH
- Status last verified
- Jan 2021
- First submitted
- 10 Oct 2019
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT04131322
- Acronym / sponsor ID
- ADA-SWITCH / AMGEVITA-HVM2019
- Conditions
- Crohn Disease, Ulcerative Colitis
- Keywords
- Loss of response, Switching, Adalimumab original, Adalimumab biosimilar
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor cancellation
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 8 Jun 2020 (actual)
- Study completion
- 8 Jun 2020 (actual)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| switch-cohort | Experimental | Drug: Amgevita 40Mg Solution for InjectionAdalimumab biosimilar |
| non-switchcohort | Active comparator | Drug: HUMIRA 40Mg Solution for InjectionAdalimumab original |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amgevita 40Mg Solution for InjectionAlso: AMGEVITAAdalimumab 40Mg Solution for Injection | Drug | switch-cohort |
| HUMIRA 40Mg Solution for InjectionAlso: HUMIRAAdalimumab 40Mg Solution for Injection | Drug | non-switchcohort |
Primary outcome
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
9 secondary outcomes
Compare the antibody formation rate.
Time frame: 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
The score of the Visual Analogue Scale (VAS)
Time frame: 0, 3, 6, 9, 12, 13 months
Maintenance of bioquimical remission trhough C-reactive protein
Time frame: 0, 3, 6, 9, 12, 13 months
Maintenance of bioquimical remission through Calprotectin values
Time frame: 0, 3, 6, 9, 12, 13 months
Drug levels
Time frame: 0, 3, 6, 9, 12, 13 months
Adverse Event
Time frame: 0, 3, 6, 9, 12, 13 months
Hospital admission rate
Time frame: 0, 3, 6, 9, 12, 13 months
Surgery rate
Time frame: 0, 3, 6, 9, 12, 13 months
Results and safety
The study was stopped early (reason given: Sponsor cancellation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federico Argüelles Arias, Md PhD principal investigator
Universitary Hospital Virgen Macarena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amgevita 40Mg Solution for Injection and HUMIRA 40Mg Solution for Injection in people with Crohn Disease and Ulcerative Colitis, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor cancellation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.