Crohn DiseaseADAPTNCT04200547
Interest of the Dosage of Adalimumab Serum Levels in Crohn's Disease Patients for Prevention of Postoperative Recurrence
A study testing Immunomonitoring-based follow-up and Standard follow-up in people with Crohn Disease, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Study comparing 2 modalities of Crohn's disease patients postoperative follow-up treated with adalimumab (Humira® or biosimilar) : immunomonitoring of adalimumab serum levels versus standard follow-up, which is based on the clinical and biological activity of the disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Immunomonitoring-based follow-up and Standard follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jan 2020to 29 Jun 2024
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient between the ages of 18 and 75
- Use of an effective method of contraception during treatment with adalimumab for women of childbearing age
- Crohn's disease diagnosed according to the criteria defined by the national and international recommendations for at least 3 months
- IIeocolic resection with ileocolic anastomosis and absence of residual macroscopic lesion, or ileocolic resection with transient ostomy and restoration of continuity
- For anti-TNF-naive patients: negative pre-anti TNF balance
- Indication of postoperative treatment for the prevention of recurrence of Crohn's disease (with at least 1 risk factor for recidivism):
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- active smoking (≥ 1 cigarette / day at the time of surgery)
- hail resection> 50 cm
- second intestinal resection
- presence of anoperineal lesions
- Penetrating impairment (B3 of the Montreal Classification)
- Biotherapy treatment for more than 6 months before the surgery
- Written and signed consent by the participant and the investigator
- Affiliated person or beneficiary of the social security system.
Who cannot join
- Intolerance or allergy to adalimumab (Humira® or biosimilar)
- Patients to whom adalimumab (Humira® or biosimilar) is contraindicated
- Intestinal stoma without restoration of continuity
- Pregnant woman (dosage of positive βHCG) or breastfeeding according to article L1121-5 of the french public health law.
- Contraindication or refusal of ileocolonoscopy at 6 months
- Patient who could not be followed regularly for psychological, social or geographical reasons
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- Vulnerable people according to article L1121-6 of the french public health law
- Persons subject to legal protection (guardianship, trusteeship) or unable to express their consent according to Article L1121-8 of the french public health law or under the protection of justice according to article L1122.2 of the CSP
- Concomitant participation of the patient in another research involving the human person.
- Patient not affiliated to the social security system (Article L.1121-11).
- Patient unable to sign the consent form
- Immunized patients (with anti-adalimumab antibodies > 10ng / mL and undetectable adalimumab levels, Elisa drug sensitive technique used) for patients already treated with adalimumab (Humira® or biosimilar) before surgery
- Patients in combination therapy with azathioprine, 6-mercaptopurine or methotrexate Post-operative, or treated by another biotherapy (infliximab, vedolizumab, ustekinumab ...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Controlled, Randomized, Multicentered, Open-label Study, Comparing 2 Modalities of Follow-up of Patients With Crohn's Disease, Postoperatively Treated With Adalimumab (Immunomonitoring vs Standard Follow-up)
Study comparing 2 modalities of Crohn's disease patients postoperative follow-up treated with adalimumab (Humira® or biosimilar) : immunomonitoring of adalimumab serum levels versus standard follow-up, which is based on the clinical and biological activity of the disease.
Read the detailed description
Patients in the experimental arm will have a post-operative follow-up based on the immunomonitoring of serum levels of adalimumab. After ileocolic resection surgery, patients will have a therapeutic optimization of their adalimumab (Humira® or biosimilar) treatment, based on their serum residual rate of adalimumab.
Patients in the control group will receive a standard post-operative follow-up, which is based on clinical and biological recurrence.
- Conditions
- Crohn Disease
- Being tested
- Immunomonitoring-based follow-up, Standard follow-up
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunomonitoring-based follow-upOther
Post-operative follow-up of Crohn's disease patients will be done through the measurement of the residual rate of the drug adalimumab in the serum. Patients will receive adalimumab treatment every other week, starting 1 month after the surgery. 3 months after the surgery, serum levels of adalimumab will be measured:
- If the level is below 5ug/mL, adalimumab treatment will be increased to every other week until the end of the study.
- If adalimumab level in the serum is above 5ug/mL, the treatment's frequency will be maintained until the end of the study.
Standard follow-upOther
Post-operative follow-up of Crohn's disease patients will be based on clinical and biological parameters. Patients will receive adalimumab treatment every other week, starting 1 month after the surgery. If clinical relapse (CDAI > 220 together with an increase of 70 points) and biological relapse (CRP > 10mg/mL and fecal calprotectin > 100 ug/g) occur, frequency of adalimumab treatment will be increased to once a week.
| Study group | Role | What they receive |
|---|---|---|
| Immunomonitoring-based follow-up | Experimental | Post-operative follow-up of Crohn's disease patients will be done through the measurement of the residual rate of the drug adalimumab in the serum. Receives: Other: Immunomonitoring-based follow-up |
| Standard follow-up | Active comparator | Post-operative follow-up of Crohn's disease patients will be based on clinical and biological parameters. This strategy is the standard strategy for post-operative follow-up of Crohn's disease patients. Receives: Other: Standard follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with a Rutgeerts score ≥ i2
The primary endpoint will be measured by ileocolonoscopy under general anesthesia after standard preparation by PEG with video recording of the examination, carried out by one of the investigators of the study in each center. An ileocolonoscopy 6 months after intestinal resection remains the reference examination for the endoscopic diagnosis of recurrence according to the endoscopic Rutgeerts score (endoscopic recurrence if Rutgeerts score ≥ i2) and allows the adaptation or the introduction of a treatment to limit clinical recurrence at 18 months.
Measured: 6 months
Secondary outcomes (5)
Percentage of patients with clinical recurrence
Evaluation of the clinical recurrence after surgery . Evaluation based on the CDAI. (clinical recurrence if CDAI ≥ 220 and ≥70 points increase from baseline CDAI), CRP (> 10mg/L) and fecal calprotectin (> 100μg/ g).
Measured: 3 and 6 months
Percentage of patients with biological recurrence
Biological recurrence will be evaluated based on CRP and fecal calprotectin:
CRP: 10 mg / L threshold to define a biological recurrence. Fecal Calprotectin: 100 μg / g threshold to define a biological recurrence
Measured: 3 and 6 months
Percentage of patients with adverse effects
The practitioner will assess (through a questionnaire) the presence or absence : of joint pain, allergic reactions, autoimmune reaction, complications at the puncture wound, infections, hospitalization .
Measured: 3 and 6 months
Rate of adalimumab in the serum
Adalimumab levels (in μg/mL) will be measured on a blood sample
Measured: 1, 3, and 6 months
Rate of anti-adalimumab antibodies in the serum
Anti-adalimumab antibodies (ng/mL) will be measured on a blood sample only in cases of undetectable adalimumabemia (Elisa Drug-sensitive technique)
Measured: 1, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start29 Jan 2020
- Primary completion29 Jun 2024
- Study completion29 Jun 2024
Why it stopped: The recruitment of participants was no longer sufficient to continue the study.
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.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter, interregional, open-label, prospective comparative PHASE III, randomized with a ratio (1:1), with 2 parallel groups (experimental group called "immunomonitoring" and control group called "standard strategy based on clinical and biological activity").
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucile BOIVINEAU, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200547
- Sponsor's protocol ID
- RECHMPL19_0071
- Other IDs
- UF 7772
- Acronym
- ADAPT
- Status last verified
- Jan 2025
- First submitted
- 12 Dec 2019
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Controlled, Randomized, Multicentered, Open-label Study, Comparing 2 Modalities of Follow-up of Patients With Crohn's Disease, Postoperatively Treated With Adalimumab (Immunomonitoring vs Standard Follow-up)
- ClinicalTrials.gov ID
- NCT04200547
- Acronym / sponsor ID
- ADAPT / RECHMPL19_0071
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The recruitment of participants was no longer sufficient to continue the study.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 29 Jun 2024 (actual)
- Study completion
- 29 Jun 2024 (actual)
- First posted
- 16 Dec 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.
Study comparing 2 modalities of Crohn's disease patients postoperative follow-up treated with adalimumab (Humira® or biosimilar) : immunomonitoring of adalimumab serum levels versus standard follow-up, which is based on the clinical and biological activity of the disease.
Detailed description
Patients in the experimental arm will have a post-operative follow-up based on the immunomonitoring of serum levels of adalimumab. After ileocolic resection surgery, patients will have a therapeutic optimization of their adalimumab (Humira® or biosimilar) treatment, based on their serum residual rate of adalimumab.
Patients in the control group will receive a standard post-operative follow-up, which is based on clinical and biological recurrence.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a multicenter, interregional, open-label, prospective comparative PHASE III, randomized with a ratio (1:1), with 2 parallel groups (experimental group called "immunomonitoring" and control group called "standard strategy based on clinical and biological activity").
| Arm | Type | Receives |
|---|---|---|
| Immunomonitoring-based follow-up | Experimental | Other: Immunomonitoring-based follow-upPost-operative follow-up of Crohn's disease patients will be done through the measurement of the residual rate of the drug adalimumab in the serum. |
| Standard follow-up | Active comparator | Other: Standard follow-upPost-operative follow-up of Crohn's disease patients will be based on clinical and biological parameters. This strategy is the standard strategy for post-operative follow-up of Crohn's disease patients. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient between the ages of 18 and 75
- Use of an effective method of contraception during treatment with adalimumab for women of childbearing age
- Crohn's disease diagnosed according to the criteria defined by the national and international recommendations for at least 3 months
- IIeocolic resection with ileocolic anastomosis and absence of residual macroscopic lesion, or ileocolic resection with transient ostomy and restoration of continuity
- For anti-TNF-naive patients: negative pre-anti TNF balance
Key exclusion criteria (13 listed)
- Intolerance or allergy to adalimumab (Humira® or biosimilar)
- Patients to whom adalimumab (Humira® or biosimilar) is contraindicated
- Intestinal stoma without restoration of continuity
- Pregnant woman (dosage of positive βHCG) or breastfeeding according to article L1121-5 of the french public health law.
- Contraindication or refusal of ileocolonoscopy at 6 months
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 |
|---|---|---|
| Immunomonitoring-based follow-upPost-operative follow-up of Crohn's disease patients will be done through the measurement of the residual rate of the drug adalimumab in the serum. Patients will receive adalimumab treatment every other week, starting 1 month after the surgery. 3 months after the surgery, serum levels of adalimumab will be measured: * If the level is below 5ug/mL, adalimumab treatment will be increased to every other week until the end of the study. * If adalimumab level in the serum is above 5ug/mL, the treatment's frequency will be maintained until the end of the study. | Other | Immunomonitoring-based follow-up |
| Standard follow-upPost-operative follow-up of Crohn's disease patients will be based on clinical and biological parameters. Patients will receive adalimumab treatment every other week, starting 1 month after the surgery. If clinical relapse (CDAI > 220 together with an increase of 70 points) and biological relapse (CRP > 10mg/mL and fecal calprotectin > 100 ug/g) occur, frequency of adalimumab treatment will be increased to once a week. | Other | Standard follow-up |
Primary outcome
Percentage of patients with a Rutgeerts score ≥ i2
Time frame: 6 months
The primary endpoint will be measured by ileocolonoscopy under general anesthesia after standard preparation by PEG with video recording of the examination, carried out by one of the investigators of the study in each center. An ileocolonoscopy 6 months after intestinal resection remains the reference examination for the endoscopic diagnosis of recurrence according to the endoscopic Rutgeerts score (endoscopic recurrence if Rutgeerts score ≥ i2) and allows the adaptation or the introduction of a treatment to limit clinical recurrence at 18 months.
5 secondary outcomes
Percentage of patients with clinical recurrence
Time frame: 3 and 6 months
Percentage of patients with biological recurrence
Time frame: 3 and 6 months
Percentage of patients with adverse effects
Time frame: 3 and 6 months
Rate of adalimumab in the serum
Time frame: 1, 3, and 6 months
Rate of anti-adalimumab antibodies in the serum
Time frame: 1, 3, and 6 months
Results and safety
The study was stopped early (reason given: The recruitment of participants was no longer sufficient to continue the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2025.
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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.
Lucile BOIVINEAU principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunomonitoring-based follow-up and Standard follow-up in people with Crohn Disease, run by University Hospital, Montpellier at 1 site in France.
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 14 inclusion and 13 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 21 Jan 2025. 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 France. 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.
Are results available for this study?
The study was stopped early (reason given: The recruitment of participants was no longer sufficient to continue the study.). 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?
Percentage of patients with a Rutgeerts score ≥ i2 (time frame: 6 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 21 Jan 2025.