CDPhase 4CURENCT03306446
Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab
A Phase 4 study testing Start adalimumab in monotherapy in people with CD, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 23 sites in 2 countries.
Trial summary
This is a prospective, longitudinal, multicenter study conducted in a cohort of patients with early CD. This study will not change the patient/physician relationship. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CD
- What is being tested?
- Start adalimumab in monotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 17 Mar 2015to Mar 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient aged 18 years old to 75 years old 2. Patient with early luminal Crohn's disease (less than 24 months since diagnosis), 3. Patient who is
- intolerant to immunosuppressants or steroids, or
- primarily not responders to immunosuppressants for at least 3 months [azathioprine: at least 2.5 mg/kg/d; 6-mercaptopurine: at least 1.5 mg/kg/d; methotrexate: 25 mg/week (subcutaneous or intramuscular route)], and/or
- not responder to steroids [prednisolone equivalent at least 40 mg/d], and/or
- steroid-dependent [unable to reduce corticosteroids below the equivalent of prednisolone 10 mg/d or budesonide < 6 mg/d within 3 months of starting corticosteroids without recurrent active disease, or who have a relapse within 3 months of stopping corticosteroids], 4. Patient with CDAI > 150, 5. Patient with at least one ulcer in at least one affected segment (Magnetic Resonance Imaging (MRI) of gastrointestinal tract or colonoscopy or by video capsule conducted after failure of conventional therapy and within 12 weeks before inclusion in the study), 6. Patient naïve for anti-TNF, 7. Patient whose physician decides to start adalimumab as monotherapy independently from the study protocol, 8. Patient followed in a centre belonging to the GETAID network. 9. Written consent.
Who cannot join
- Patient with active complex perianal fistula according to the definition of the American Gastroenterological Association (AGA) [high anal fistula, abscess, proctitis, multiple external openings],
- Patient with stoma,
- previous surgery in IBD
- Pregnant or breastfeeding women, absence of contraception
- Patient with any contra-indication to adalimumab.
- Patient with any contra-indication to MRI
Show all 9Show fewer
- Minors and people unable to give their consent (because of their physical or mental state).
- Subject who has not given his/her consent to participate.
- Subject participating in another study.
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
France22 sites
Chu Amiens
Amiens
Chu Besancon
Besançon
CHU de Caen- Hopital de la Cote de Nacre
Caen, 14033
CHU de CLERMONT FERRAND- Hopital Estain
Clermont-Ferrand, 67000
APHP- Hopital BEAUJON
Clichy, 92110
CHU de Colmar- Hopital Trousseau Medecine A
Colmar, 68024
Chu Lille
Lille
CHU de Montpellier- Hopital saint Eloi
Montpellier, 34295
CHU NANTES - Hôpital Hôtel Dieu
Nantes, 44093
CHU de NICE- Hopital Archet 2
Nice, 06200
CHU de Nimes- Hopital Carémeau
Nîmes, 30029
APHP- Hopital COCHIN
Paris, 75014
APHP- Hopital BICHAT
Paris, 75018
IMM
Paris, 75674
CHU Bordeaux- Hopital Haut Levèque
Pessac, 33600
CHU LYON- Hopital Lyon Sud
Pierre-Bénite, 69495
CHU RENNES - Hopital Pontchaillou
Rennes
CHU de Saint Etienne- Hopital Nord
Saint-Priest-en-Jarez, 42270
CHU de TOULOUSE
Toulouse, 31403
CHU de Tours - Hopital Trousseau
Tours, 37044
CH Valenciennes
Valenciennes, 59322
CHU NANCY - Hopital Brabois
Vandœuvre-lès-Nancy, 54500
About this study
This is a prospective, longitudinal, multicenter study conducted in a cohort of patients with early CD. This study will not change the patient/physician relationship.
Read the detailed description
The main objective will be to evaluate the sustained deep remission rate one year after discontinuation of a 12 month course of adalimumab in adult patients with early CD who have achieved deep remission at 12 months AND who were already in clinical remission (CDAI < 150) and biomarker remission (CRP < 5 mg/L and fecal calprotectin < 250) at 6 months. The study will also address several questions:
- What is the rate of deep remission after a 12-month course of adalimumab in early CD patients?
- What is the rate of deep remission 12 months after adalimumab discontinuation in patients with deep remission after a 12-month course of adalimumab (thus defining sustained deep remission) AND who were already in clinical remission (CDAI < 150) and biomarker remission (CRP < 5 mg/L and fecal calprotectin < 250) at 6 months?
- What are the consequences of a treatment with adalimumab on the natural course of CD and long-term clinical outcomes (bowel damage, CD related surgeries and hospitalization, and patient-reported outcomes)? Therefore the study will give information on the effect of a 12-month course of adalimumab in early CD patients, impact of "drug holiday" after deep remission has been achieved, and long term effect of adalimumab on early CD course (relapses, CD-related surgery and hospitalizations, bowel damage, and patient-reported outcomes). The study will also assess predictors of loss of deep remission at 2-year evaluation in patients who achieved 1-year deep remission. Efficacy and tolerability of adalimumab will be assessed.
- Conditions
- CD
- Being tested
- Start adalimumab in monotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Start adalimumab in monotherapyDrug
Also called begin humira in monotherapie in Early crohn disease patient
Discontinuation of Adalimumab in patients who achieved deep remission
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab in monotherapy | Experimental | Start Adalimumab in monotherapy at 160 mg at inclusion, 80 mg on 2nd week and 40 mg/week each other week over 12 months. Receives: Drug: Start adalimumab in monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained deep remission rate
Number of patients with sustained deep remission at one year
Measured: 12 months
Secondary outcomes (1)
2-year deep remission rate
Number of patients with 2-year deep remission rate among patients who did not achieve 1-year remission
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start17 Mar 2015
- Primary completionMar 2021
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CDStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoram Bouhnik, MD, Principal investigator, Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesLaurent Peyrin-Biroulet, MD, PhD, Principal investigator, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306446
- Sponsor's protocol ID
- GETAID 2013-1
- Acronym
- CURE
- Status last verified
- May 2023
- First submitted
- 21 Jun 2015
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab
- ClinicalTrials.gov ID
- NCT03306446
- Acronym / sponsor ID
- CURE / GETAID 2013-1
- Conditions
- CD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesUniversity, hospital or other
- Study start
- 17 Mar 2015 (actual)
- Primary completion
- Mar 2021 (actual)
- Study completion
- Mar 2025 (estimated)
- First posted
- 11 Oct 2017 (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.
This is a prospective, longitudinal, multicenter study conducted in a cohort of patients with early CD. This study will not change the patient/physician relationship.
Detailed description
The main objective will be to evaluate the sustained deep remission rate one year after discontinuation of a 12 month course of adalimumab in adult patients with early CD who have achieved deep remission at 12 months AND who were already in clinical remission (CDAI < 150) and biomarker remission (CRP < 5 mg/L and fecal calprotectin < 250) at 6 months. The study will also address several questions:
- What is the rate of deep remission after a 12-month course of adalimumab in early CD patients?
- What is the rate of deep remission 12 months after adalimumab discontinuation in patients with deep remission after a 12-month course of adalimumab (thus defining sustained deep remission) AND who were already in clinical remission (CDAI < 150) and biomarker remission (CRP < 5 mg/L and fecal calprotectin < 250) at 6 months?
- What are the consequences of a treatment with adalimumab on the natural course of CD and long-term clinical outcomes (bowel damage, CD related surgeries and hospitalization, and patient-reported outcomes)? Therefore the study will give information on the effect of a 12-month course of adalimumab in early CD patients, impact of "drug holiday" after deep remission has been achieved, and long term effect of adalimumab on early CD course (relapses, CD-related surgery and hospitalizations, bowel damage, and patient-reported outcomes). The study will also assess predictors of loss of deep remission at 2-year evaluation in patients who achieved 1-year deep remission. Efficacy and tolerability of adalimumab will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab in monotherapy | Experimental | Drug: Start adalimumab in monotherapyStart Adalimumab in monotherapy at 160 mg at inclusion, 80 mg on 2nd week and 40 mg/week each other week over 12 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patient aged 18 years old to 75 years old 2. Patient with early luminal Crohn's disease (less than 24 months since diagnosis), 3. Patient who is
- intolerant to immunosuppressants or steroids, or
- primarily not responders to immunosuppressants for at least 3 months [azathioprine: at least 2.5 mg/kg/d; 6-mercaptopurine: at least 1.5 mg/kg/d; methotrexate: 25 mg/week (subcutaneous or intramuscular route)], and/or
- not responder to steroids [prednisolone equivalent at least 40 mg/d], and/or
- steroid-dependent [unable to reduce corticosteroids below the equivalent of prednisolone 10 mg/d or budesonide < 6 mg/d within 3 months of starting corticosteroids without recurrent active disease, or who have a relapse within 3 months of stopping corticosteroids], 4. Patient with CDAI > 150, 5. Patient with at least one ulcer in at least one affected segment (Magnetic Resonance Imaging (MRI) of gastrointestinal tract or colonoscopy or by video capsule conducted after failure of conventional therapy and within 12 weeks before inclusion in the study), 6. Patient naïve for anti-TNF, 7. Patient whose physician decides to start adalimumab as monotherapy independently from the study protocol, 8. Patient followed in a centre belonging to the GETAID network. 9. Written consent.
Key exclusion criteria (9 listed)
- Patient with active complex perianal fistula according to the definition of the American Gastroenterological Association (AGA) [high anal fistula, abscess, proctitis, multiple external openings],
- Patient with stoma,
- previous surgery in IBD
- Pregnant or breastfeeding women, absence of contraception
- Patient with any contra-indication to adalimumab.
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 |
|---|---|---|
| Start adalimumab in monotherapyAlso: begin humira in monotherapie in Early crohn disease patientDiscontinuation of Adalimumab in patients who achieved deep remission | Drug | Adalimumab in monotherapy |
Primary outcome
Sustained deep remission rate
Time frame: 12 months
Number of patients with sustained deep remission at one year
1 secondary outcome
2-year deep remission rate
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
Yoram Bouhnik, MD principal investigator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Laurent Peyrin-Biroulet, MD, PhD principal investigator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Start adalimumab in monotherapy in people with CD, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 23 sites in 2 countries.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in France, Belgium. 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?
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?
Sustained deep remission rate (time frame: 12 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 31 May 2023.