Clinical trial • Phase III • Gastroenterology
Adalimumab for Crohn’s Disease
Phase III trial of Adalimumab for Crohn’s Disease.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Crohn’s Disease
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 30-07-2024
- First CTIS Authorization Date
- 20-08-2024
Trial design
Randomised, open-label, arm 1 (study treatment): combination of subcutaneous administration of adalimumab at a dose of 160mg (w0) - 80mg (w2) - 40mg (w4) and then 40mg every other week (eow) and oral aza capsules at a daily dose of 2.5 mg per kilogram. arm 2 (comparator treatment): combination of subcutaneous administration of adalimumab at a dose of 160mg (w0) - 80mg (w2) - 40mg (w4) and then 40mg every other week (eow) and sub-cutaneous methotrexate (mtx) 25 mg once a week.-controlled Phase III trial across 28 sites in France.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Arm 1 (study treatment): Combination of subcutaneous administration of adalimumab at a dose of 160mg (W0) - 80mg (W2) - 40mg (W4) and then 40mg every other week (EOW) and oral AZA capsules at a daily dose of 2.5 mg per kilogram. Arm 2 (comparator treatment): Combination of subcutaneous administration of adalimumab at a dose of 160mg (W0) - 80mg (W2) - 40mg (W4) and then 40mg every other week (EOW) and sub-cutaneous methotrexate (MTX) 25 mg once a week.
- Target Sample Size
- 166
- Trial Duration For Participant
- 728
Eligibility
Recruits 166 No vulnerable population selected. 'Adults protected by law' are listed in the exclusion criteria. Informed consent documents (L1 Subject information and informed consent form) are provided; only adult participants (>18 years) are eligible, so no assent for minors is applicable..
- Pregnancy Exclusion
- Planning pregnancy, pregnancy or lactation or absence of contraception
- Vulnerable Population
- No vulnerable population selected. 'Adults protected by law' are listed in the exclusion criteria. Informed consent documents (L1 Subject information and informed consent form) are provided; only adult participants (>18 years) are eligible, so no assent for minors is applicable.
Inclusion criteria
- {"criterion_text":"- Male or female patients with age > 18 years\n- CD for at least 6 weeks\n- Clinically active with CDAI > 150\n- Active inflammation by endoscopy (SES-CD ≥6 (or in isolated ileum disease SES-CD ≥4)) at baseline\n- Not responder to conventional therapy (steroids and/or immunosuppressants) or are intolerant to or have medical contraindications for such therapies and initiating treatment with adalimumab\n- Patient followed in a centre belonging to the GETAID network\n- Fertile men and women of childbearing potential included in the protocol should use adequate methods of contraception according to study drug SMPCs"}
Exclusion criteria
- {"criterion_text":"- Short bowel syndrome, ostomy, symptomatic stricture, abscess, recent history of abdominal surgery (<3 months)\n- Use of any investigational drug within 30 days\n- Adults protected by law\n- Non-passable colonic stricture\n- Previous intolerance to thiopurines or MTX\n- Previous exposition to adalimumab\n- Contra-indication to adalimumab\n- Contra-indication to immunosuppressants or anti-TNF\n- Others serious simultaneous illness that could interfere with study participation\n- Planning pregnancy, pregnancy or lactation or absence of contraception\n- Known substance abusers"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Endoscopic response defined as a decrease of at least 50% of the SES-CD at week W26 as compared to baseline","definition_or_measurement_approach":"Endoscopic response defined as a decrease of at least 50% of the SES-CD at week W26 compared to baseline (SES-CD assessed endoscopically at baseline and at W26)."}
Secondary endpoints
- {"endpoint_text":"- Clinical response at each visit","definition_or_measurement_approach":"Clinical response assessed at each visit (as stated: 'at each visit')."}
- {"endpoint_text":"- Clinical remission at each visit","definition_or_measurement_approach":"Clinical remission assessed at each visit (as stated: 'at each visit')."}
- {"endpoint_text":"- Corticosteroid-free clinical remission at W12, W26, W52, W78 and W104","definition_or_measurement_approach":"Corticosteroid-free clinical remission assessed at weeks W12, W26, W52, W78 and W104."}
- {"endpoint_text":"- Necessity of adalimumab optimization during follow-up","definition_or_measurement_approach":"Monitoring whether adalimumab optimization is required during follow-up (as stated)."}
- {"endpoint_text":"- AZA, MTX and adalimumab withdrawal during follow-up","definition_or_measurement_approach":"Recording withdrawal of AZA, MTX and adalimumab during follow-up (as stated)."}
- {"endpoint_text":"- Trough serum levels and antibodies to adalimumab at W12-W26, W52, W78 and W104","definition_or_measurement_approach":"Measurement of trough serum adalimumab levels and anti-adalimumab antibodies at W12-W26, W52, W78 and W104."}
- {"endpoint_text":"- Change in IBD-Q and change in IBD-Disability index between W0 and W12, W26, W52, W78 and W104","definition_or_measurement_approach":"Assessment of change in IBD-Q and IBD-Disability index between baseline (W0) and specified timepoints W12, W26, W52, W78 and W104."}
- {"endpoint_text":"- Change in C-reactive protein (CRP) level between W0, W12, W26, W52, W78 and W104","definition_or_measurement_approach":"Measurement of CRP at baseline and at W12, W26, W52, W78 and W104 and assessment of change."}
- {"endpoint_text":"- Change in Calprotectin level between W0, W12, W26, W52, W78 and W104","definition_or_measurement_approach":"Measurement of fecal calprotectin at baseline and at W12, W26, W52, W78 and W104 and assessment of change."}
- {"endpoint_text":"- Endoscopic remission (SES-CD< 3) and ulcer free endoscopy at W26","definition_or_measurement_approach":"Endoscopic remission defined as SES-CD < 3 and assessment of ulcer-free endoscopy at W26."}
- {"endpoint_text":"- Deep remission at W26","definition_or_measurement_approach":"Assessment of deep remission at W26 (as stated)."}
- {"endpoint_text":"- CD-related hospitalization during follow-up","definition_or_measurement_approach":"Recording Crohn's disease-related hospitalizations during follow-up (as stated)."}
- {"endpoint_text":"- CD-related surgery during follow-up","definition_or_measurement_approach":"Recording Crohn's disease-related surgeries during follow-up (as stated)."}
- {"endpoint_text":"- Occurrence of adverse events","definition_or_measurement_approach":"Recording occurrence of adverse events (as stated)."}
Recruitment
- Registry Or Advocacy Recruitment
- Yes
- Planned Sample Size
- 166
- Recruitment Window Months
- 60
- Consent Approach
- Informed consent obtained from adult participants (>18 years). Subject information and informed consent form documents are provided (L1_SIS_and_ICF_PATIENT, L1_ICF). 'Adults protected by law' are excluded. No minors included, so no assent procedures are applicable.
Methods
- Recruitment at participating hospital/clinic sites in France, specifically centres belonging to the GETAID network (inclusion criterion: 'Patient followed in a centre belonging to the GETAID network').
Geography
- Total Number Of Sites
- 28
- Total Number Of Participants
- 166
France
- Earliest CTIS Part Ii Submission Date
- 17-05-2024
- Latest Decision Or Authorization Date
- 15-10-2025
- Processing Time Days
- 516
- Number Of Sites
- 28
- Number Of Participants
- 166
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- hépato-gastro-entérologie
- Principal Investigator Name
- Jean-Marc GORNET
- Principal Investigator Email
- jean-marc.gornet@aphp.fr
- Contact Person Name
- Jean-Marc GORNET
- Contact Person Email
- jean-marc.gornet@aphp.fr
- Site Name
- Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
- Department Name
- hépatogastroentérologie
- Principal Investigator Name
- Philippe AH-SOUNE
- Principal Investigator Email
- PHILIPPE.AH-SOUNE@ch-toulon.fr
- Contact Person Name
- Philippe AH-SOUNE
- Contact Person Email
- PHILIPPE.AH-SOUNE@ch-toulon.fr
- Site Name
- Centre Medico Chirurgical Ambroise Pare Hartmann
- Department Name
- gastroentérologie
- Principal Investigator Name
- Yoram BOUHNIK
- Principal Investigator Email
- yoram.bouhnik@bjn.aphp.fr
- Contact Person Name
- Yoram BOUHNIK
- Contact Person Email
- yoram.bouhnik@bjn.aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- gastroentérologie et pancréatologie
- Principal Investigator Name
- Cyrielle GILLETTA DE SAINT JOSEPH
- Principal Investigator Email
- gilletta.c@chu-toulouse.fr
- Contact Person Name
- Cyrielle GILLETTA DE SAINT JOSEPH
- Contact Person Email
- gilletta.c@chu-toulouse.fr
- Site Name
- Centre Hospitalier Intercommunal Creteil
- Department Name
- hépatogastroentérologie
- Principal Investigator Name
- Mathias VIDON
- Principal Investigator Email
- mathias.vidon@chicreteil.fr
- Contact Person Name
- Mathias VIDON
- Contact Person Email
- mathias.vidon@chicreteil.fr
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- hépatologie gastro-enterologie
- Principal Investigator Name
- Guillaume SAVOYE
- Principal Investigator Email
- guillaume.savoye@chu-rouen.fr
- Contact Person Name
- Guillaume SAVOYE
- Contact Person Email
- guillaume.savoye@chu-rouen.fr
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- gastroentérologie hépatologie
- Principal Investigator Name
- Antony BUISSON
- Principal Investigator Email
- abuisson@chu.clermontferrand.fr
- Contact Person Name
- Antony BUISSON
- Contact Person Email
- abuisson@chu.clermontferrand.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- hépato-gastro-enterologie
- Principal Investigator Name
- David LAHARIE
- Principal Investigator Email
- david.laharie@chu-bordeaux.fr
- Contact Person Name
- David LAHARIE
- Contact Person Email
- david.laharie@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- gastro-enterologie et hépatologie
- Principal Investigator Name
- Guillaume BOUGUEN
- Principal Investigator Email
- guillaume.bouguen@chu-rennes.fr
- Contact Person Name
- Guillaume BOUGUEN
- Contact Person Email
- guillaume.bouguen@chu-rennes.fr
- Site Name
- Centre Hospitalier De Tourcoing
- Department Name
- hépatogastroentérologie
- Principal Investigator Name
- Noemie TAVERNIER
- Principal Investigator Email
- ntavernier@ch-tourcoing.fr
- Contact Person Name
- Noemie TAVERNIER
- Contact Person Email
- ntavernier@ch-tourcoing.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- hépato-gastro-enterologie
- Principal Investigator Name
- Arnaud BOUREILLE
- Principal Investigator Email
- arnaud.boureille@chu-nantes.fr
- Contact Person Name
- Arnaud BOUREILLE
- Contact Person Email
- arnaud.boureille@chu-nantes.fr
- Site Name
- CHRU De Nancy
- Department Name
- hépatogastroentérologie
- Principal Investigator Name
- Laurent PEYRIN-BIROULET
- Principal Investigator Email
- peyrinbiroulet@gmail.com
- Contact Person Name
- Laurent PEYRIN-BIROULET
- Contact Person Email
- peyrinbiroulet@gmail.com
- Site Name
- Centre Hospitalier Valence
- Department Name
- gastroentérologie
- Principal Investigator Name
- Celine MONTUCLARD
- Principal Investigator Email
- cmonlucard@ch-valence.fr
- Contact Person Name
- Celine MONTUCLARD
- Contact Person Email
- cmonlucard@ch-valence.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- hépato-gastro-entérologie
- Principal Investigator Name
- Xavier ROBLIN
- Principal Investigator Email
- xavier.roblin@chu-st-etienne.fr
- Contact Person Name
- Xavier ROBLIN
- Contact Person Email
- xavier.roblin@chu-st-etienne.fr
- Site Name
- Centre Hospitalier De Roubaix
- Department Name
- gastroentérologie
- Principal Investigator Name
- Nicolas DUVEAU
- Principal Investigator Email
- nicolas.duveau@gmail.fr
- Contact Person Name
- Nicolas DUVEAU
- Contact Person Email
- nicolas.duveau@gmail.fr
- Site Name
- Centre Hospitalier De Colmar
- Department Name
- gastroentérologie
- Principal Investigator Name
- Laurianne PLASTARAS
- Principal Investigator Email
- laurianne.plastaras@ch-colmar.fr
- Contact Person Name
- Laurianne PLASTARAS
- Contact Person Email
- laurianne.plastaras@ch-colmar.fr
- Site Name
- Centre Hospitalier De La Cote Basque
- Department Name
- gastroentérologie
- Principal Investigator Name
- Felix GOUTORBE
- Principal Investigator Email
- fgoutorbe@ch-cotebasque.fr
- Contact Person Name
- Felix GOUTORBE
- Contact Person Email
- fgoutorbe@ch-cotebasque.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- gastroentérologie
- Principal Investigator Name
- Maria NACHURY
- Principal Investigator Email
- maria.nachury@chru-lille.fr
- Contact Person Name
- Maria NACHURY
- Contact Person Email
- maria.nachury@chru-lille.fr
- Site Name
- Hopital Beaujon
- Department Name
- hépatologie et gastro-enterologie
- Principal Investigator Name
- Francisca JOLY
- Principal Investigator Email
- francisca.joly@bjn.aphp.fr
- Contact Person Name
- Francisca JOLY
- Contact Person Email
- francisca.joly@bjn.aphp.fr
- Site Name
- CHU Besancon
- Department Name
- gastro-enterologie
- Principal Investigator Name
- Lucine VUITTON
- Principal Investigator Email
- lvuitton@chu-besancon.fr
- Contact Person Name
- Lucine VUITTON
- Contact Person Email
- lvuitton@chu-besancon.fr
- Site Name
- Centre Hospitalier Universitaire De Caen Normandie
- Department Name
- hépato-gastro-entérologie
- Principal Investigator Name
- Cléa ROUILLON
- Principal Investigator Email
- rouillon-cl@chu-caen.fr
- Contact Person Name
- Cléa ROUILLON
- Contact Person Email
- rouillon-cl@chu-caen.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- hepato-gastro-enterologie
- Principal Investigator Name
- Xavier HEBUTERNE
- Principal Investigator Email
- hebuterne.x@chu-nice.fr
- Contact Person Name
- Xavier HEBUTERNE
- Contact Person Email
- hebuterne.x@chu-nice.fr
- Site Name
- Centre Hospitalier Universitaire Reims
- Department Name
- hépato-gastro-enterologie
- Principal Investigator Name
- Quentin LAURENT BADR
- Principal Investigator Email
- qlaurent@chu-reims.fr
- Contact Person Name
- Quentin LAURENT BADR
- Contact Person Email
- qlaurent@chu-reims.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- hépatogastroentérologie
- Principal Investigator Name
- Driffa MOUSSATA
- Principal Investigator Email
- D.MOUSSATA@chu-tours.fr
- Contact Person Name
- Driffa MOUSSATA
- Contact Person Email
- D.MOUSSATA@chu-tours.fr
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- gastroentérologie
- Principal Investigator Name
- Mathurin FUMERY
- Principal Investigator Email
- fumery.mathurin@chu-amiens.fr
- Contact Person Name
- Mathurin FUMERY
- Contact Person Email
- fumery.mathurin@chu-amiens.fr
- Site Name
- Centre Hospitalier Henri Mondor
- Department Name
- gastro-enterologie
- Principal Investigator Name
- Mathieu UZZAN
- Principal Investigator Email
- mathieu.uzzan@aphp.fr
- Contact Person Name
- Mathieu UZZAN
- Contact Person Email
- mathieu.uzzan@aphp.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- hépatologie et gastro-enterologie
- Principal Investigator Name
- Stéphane NANCEY
- Principal Investigator Email
- stephane.nancey@chu-lyon.fr
- Contact Person Name
- Stéphane NANCEY
- Contact Person Email
- stephane.nancey@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- hepato-gastro-enterologie
- Principal Investigator Name
- Romain ALTWEGG
- Principal Investigator Email
- r-altwegg@chu-montpellier.fr
- Contact Person Name
- Romain ALTWEGG
- Contact Person Email
- r-altwegg@chu-montpellier.fr
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Universitaire Amiens Picardie
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- Humira 20 mg solution for injection in pre-filled syringe
- Active Substance
- Adalimumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous use
- Route
- Subcutaneous
- Authorisation Status
- Authorised (marketing authorisation present)
- Starting Dose
- 160 mg (W0) - 80 mg (W2) - 40 mg (W4) then 40 mg every other week
- Dose Levels
- 160 mg; 80 mg; 40 mg; maintenance 40 mg EOW
- Frequency
- Loading doses at W0, W2, W4 then every other week
- Maximum Dose
- 160 mg (loading dose)
- Investigational Product Name
- IMUREL 25 mg, comprimé pelliculé
- Active Substance
- Azathioprine
- Modality
- Small molecule
- Routes Of Administration
- Oral use
- Route
- Oral
- Authorisation Status
- Authorised (marketing authorisation present)
- Starting Dose
- 2.5 mg per kilogram daily
- Dose Levels
- 2.5 mg/kg daily
- Frequency
- Daily
- Maximum Dose
- 2.5 mg/kg daily
- Investigational Product Name
- METOJECT 25 mg/0,5 ml, solution injectable en seringue préremplie
- Active Substance
- Methotrexate
- Modality
- Small molecule
- Routes Of Administration
- Subcutaneous use
- Route
- Subcutaneous
- Authorisation Status
- Authorised (marketing authorisation present)
- Starting Dose
- 25 mg once a week (subcutaneous)
- Dose Levels
- 25 mg weekly
- Frequency
- Once a week
- Maximum Dose
- 25 mg (weekly)
- Combination Treatment
- Yes
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