Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
166
Countries
1
Sites
28
Crohn’s Disease
To compare the endoscopic response to AZA and to MTX in combination with adalimumab in patients with CD
Key facts
- Sponsor
- Centre Hospitalier Universitaire Amiens Picardie
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2024-08-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514633-38-00
- EudraCT number
- 2021-002047-29
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Safety
To compare the endoscopic response to AZA and to MTX in combination with adalimumab in patients with CD
Secondary objectives 7
- To compare AZA to MTX in combination therapy with adalimumab on clinical efficacy (remission and response)
- To compare AZA to MTX in combination therapy with adalimumab in CD on the pharmacokinetics of adalimumab
- To compare AZA to MTX in combination therapy with adalimumab on the level of inflammatory biomarkers
- To compare the impact of AZA to MTX in combination therapy with adalimumab on CD-related disability
- To compare the impact of AZA to MTX in combination therapy with adalimumab on CD-related quality of life
- To compare the impact of AZA to MTX in combination therapy with adalimumab on CD natural history (surgeries and hospitalizations)
- To compare the safety of AZA to MTX in combination therapy with adalimumab
Conditions and MedDRA coding
Crohn’s Disease
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Essai contrôlé randomisé ouvert de supériorité avec randomisation du traitement assigné (AZA ou MTX) Group 1:Combination of subcutaneous administration of adalimumab and oral AZA capsules at a daily dose of 2.5 mg per kilogram.
Group 2:Combination of sub-cutaneous administration of adalimumab and sub-cutaneous MTX 25 mg once a week.
|
Randomised Controlled | None | study treatment: Combination of subcutaneous administration of adalimumab at a dose of 160mg (W0) - 80mg (W2)-40mg (W4) and then 40mg EOW (every other week) and oral AZA capsules at a daily dose of 2.5 mg per kilogram. comparator treatment: Combination of sub-cutaneous administration of adalimumab at a dose of 160mg (W0) - 80mg (W2) -40mg (W4) and then 40mg every other week (EOW) and sub-cutaneous MTX 25 mg once a week. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Male or female patients with age > 18 years
- CD for at least 6 weeks
- Clinically active with CDAI > 150
- Active inflammation by endoscopy (SES-CD ≥6 (or in isolated ileum disease SES-CD ≥4)) at baseline
- 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
- Patient followed in a centre belonging to the GETAID network
- Fertile men and women of childbearing potential included in the protocol should use adequate methods of contraception according to study drug SMPCs
Exclusion criteria 11
- Short bowel syndrome, ostomy, symptomatic stricture, abscess, recent history of abdominal surgery (<3 months)
- Non-passable colonic stricture
- Previous intolerance to thiopurines or MTX
- Previous exposition to adalimumab
- Contra-indication to adalimumab
- Contra-indication to immunosuppressants or anti-TNF
- Others serious simultaneous illness that could interfere with study participation
- Planning pregnancy, pregnancy or lactation or absence of contraception
- Known substance abusers
- Use of any investigational drug within 30 days
- Adults protected by law
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Endoscopic response defined as a decrease of at least 50% of the SES-CD at week W26 as compared to baseline
Secondary endpoints 14
- Clinical response at each visit
- Clinical remission at each visit
- Corticosteroid-free clinical remission at W12, W26, W52, W78 and W104
- Necessity of adalimumab optimization during follow-up
- AZA, MTX and adalimumab withdrawal during follow-up
- Trough serum levels and antibodies to adalimumab at W12-W26, W52, W78 and W104
- Change in IBD-Q and change in IBD-Disability index between W0 and W12, W26, W52, W78 and W104
- Change in C-reactive protein (CRP) level between W0, W12, W26, W52, W78 and W104
- Change in Calprotectin level between W0, W12, W26, W52, W78 and W104
- Endoscopic remission (SES-CD< 3) and ulcer free endoscopy at W26
- Deep remission at W26
- CD-related hospitalization during follow-up
- CD-related surgery during follow-up
- Occurrence of adverse events
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
IMUREL 25 mg, comprimé pelliculé
PRD980770 · Product
- Active substance
- Azathioprine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 2.5 mg/kg milligram(s)/kilogram
- Max total dose
- 1820 mg/kg milligram(s)/kilogram
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX01 — AZATHIOPRINE
- Marketing authorisation
- 34009 364 142 6 6
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Humira 20 mg solution for injection in pre-filled syringe
PRD5952375 · Product
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 160 mg milligram(s)
- Max total dose
- 4240 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AB04 — -
- Marketing authorisation
- EU/1/03/256/022
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
METOJECT 25 mg/0,5 ml, solution injectable en seringue préremplie
PRD779196 · Product
- Active substance
- Methotrexate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 2600 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BA01 — METHOTREXATE
- Marketing authorisation
- 34009 268 899 2 0
- MA holder
- MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire Amiens Picardie
- Sponsor organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Address
- 1 Rond Point Du Pr Christian Cabrol
- City
- Amiens Cedex 1
- Postcode
- 80054
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- Mathurin FUMERY
Public contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- Mathurin FUMERY
Locations
1 EU/EEA country · 28 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 166 | 28 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Henri Mondor
gastro-enterologie, 50 Avenue De La Republique, 15002, Aurillac Cedex
Centre Hospitalier Universitaire De Nantes
hépatologie et gastro-enterologie, 1 Place Alexis Ricordeau, 44000, Nantes
Hospices Civils De Lyon
hépatologie et gastro-enterologie, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Universitaire De Rennes
gastro-enterologie et hépatologie, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire Reims
hépato-gastro-enterologie, Rue Du General Koenig, 51092, Reims Cedex
Centre Hospitalier Universitaire De Bordeaux
hépato-gastro-enterologie, Avenue De Magellan, 33600, Pessac
CHU Besancon
gastro-enterologie, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Centre Hospitalier Universitaire De Lille
gastroentérologie, Rue Michel Polonowski, 59000, Lille
Hopital Beaujon
hépatologie et gastro-enterologie, 100 Boulevard Du General Leclerc, 92110, Clichy
Centre Hospitalier Universitaire Amiens Picardie
gastroentérologie, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Centre Hospitalier De Tourcoing
hépatogastroentérologie, 155 Rue Du President Coty, Bp 40619, Tourcoing Cedex
Centre Hospitalier Universitaire De Caen Normandie
hépato-gastro-entérologie, Avenue De La Cote De Nacre, 14000, Caen
Centre Medico Chirurgical Ambroise Pare Hartmann
gastroentérologie, 25 Boulevard Victor Hugo, 92200, Neuilly-Sur-Seine
Centre Hospitalier De Colmar
gastroentérologie, 39 Avenue De La Liberte, Bp 60535, Colmar Cedex
Centre Hospitalier De Roubaix
gastroentérologie, 11 Boulevard Lacordaire, Hopital Victor Provo, Roubaix
Centre Hospitalier De La Cote Basque
gastroentérologie, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
Centre Hospitalier Valence
gastroentérologie, 179 Boulevard Marechal Juin, 26000, Valence
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
hépatogastroentérologie, 54 Rue Henri Sainte Claire Deville, 83100, Toulon
Centre Hospitalier Intercommunal Creteil
hépatogastroentérologie, 40 Avenue De Verdun, 94010, Creteil Cedex
Centre Hospitalier Regional Universitaire De Tours
hépatogastroentérologie, 2 Boulevard Tonnelle, 37000, Tours
Centre Hospitalier Universitaire De Toulouse
gastroentérologie et pancréatologie, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Universitaire De Montpellier
hepato-gastro-enterologie, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
University Hospital Of Clermont-Ferrand
gastroentérologie hépatologie, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
CHRU De Nancy
hépatogastroentérologie, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Centre Hospitalier Universitaire De Nice
hepato-gastro-enterologie, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Universitaire De Saint Etienne
hépato-gastro-entérologie, St Priest En Jarez, 25 Boulevard Pasteur, St Etienne Cedex 2
Centre Hospitalier Universitaire Rouen
hépatologie gastro-enterologie, 1 Rue De Germont, Bp 96031, Rouen Cedex
Assistance Publique Hopitaux De Paris
hépato-gastro-entérologie, Porte 23, 1 Avenue Claude Vellefaux, Paris Cedex 10
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-514633-38-00 | 6.0 |
| Protocol (for publication) | D1_Protocol V6_2024-514633-38-00_04Aug2025_TC | 6.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ICF V5_2024-514633-38-00_04Aug2025_TC | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_PATIENT | 5.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_SmPC HUMIRA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_SmPC IMUREL | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_SmPC METOJECT | 1 |
| Synopsis of the protocol (for publication) | D1_Synopsis V6_2024-514633-38-00 _04AuG2025_Clean | 6.0 |
| Synopsis of the protocol (for publication) | D1_Synopsis V6_2024-514633-38-00 _04AuG2025_TC | 6.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-30 | France | Acceptable 2024-08-19
|
2024-08-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-18 | France | Acceptable 2025-10-15
|
2025-10-15 |