Actively Recruiting
A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab
Led by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Updated on 2023-05-31
238
Participants Needed
24
Research Sites
432 weeks
Total Duration
On this page
Sponsors
G
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
PHASE: IV DESCRIPTIVE: Randomized, interventional, open label multicenter trial POPULATION: Moderate to severe ulcerative colitis STUDY TREATMENTS: Patients will all receive Adalimumab 160/80/40mg EOW until V1 (W14) followed by 40mg EOW until V2 (W26) and could be optimized up to 80mg EOW (or 40 EW according to patient and/or investigator preference) for two months and then could be optimized up to 80mg EOW (or 40 EW according to patient and/or investigator preference) and azathioprine (2.0/2.5 mg/kg/ day) or methotrexate (25 mg EW) until V3 (W 38). OBJECTIVES: To assess the impact of a treat to target treatment follow up by e-Monitoring and fecal calprotectin dosing at home associated to an appropriate patient education versus standard treatment follow up at W48 in patients requiring a treatment with adalimumab (Humira®).
CONDITIONS
Official Title
A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with moderately-to-severely active ulcerative colitis who had an inadequate response or intolerance to steroids, thiopurines, methotrexate, or vedolizumab, or no response to an adequate steroid course
- Age 18 years and older but less than 75 years
- Patients scheduled to start treatment with adalimumab
- Nafive to anti-TNF therapy and other biologics effective for ulcerative colitis except vedolizumab
- Nafive to JAK inhibitors
- Moderately-to-severely active ulcerative colitis for at least 3 months with a Mayo score of 6-12 and endoscopy subscore of at least 2
- Established diagnosis of ulcerative colitis for at least 3 months
- Current treatment with oral 5-ASA unless contraindicated
- Stopped azathioprine, 6-mercaptopurine, or methotrexate two weeks before inclusion
- Use of contraception for females with childbearing potential throughout the trial
- Familiar with smartphone and internet use
You will not qualify if you...
- Unable to give consent due to physical or mental condition
- No written consent provided
- Pregnancy or breastfeeding
- Severe acute colitis or imminent risk of colectomy
- History of colectomy
- History of colonic mucosal dysplasia or unresected adenomatous polyps
- Positive stool test for enteric pathogens or Clostridium difficile toxin
- Use of oral corticosteroids over 40 mg prednisone (or equivalent) daily at inclusion
- Use of cyclosporine, tacrolimus, anti-TNF therapy, other biologics (except vedolizumab), JAK inhibitors, or investigational agents within 5 half-lives before trial start
- Contraindications to anti-TNF therapy including active infection, untreated latent tuberculosis, severe heart failure, recent malignancy, demyelinating neurological disease, or recent live vaccines
- Dominant arm deficiency or physical impairment affecting test performance
- Use of prohibited medications
- Participation in another trial or follow-up from another trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Centre hospitalier de Cholet
Cholet, Maine Et Loire, France, 49300
Active, Not Recruiting
2
CHU Amiens- Picardie (site Sud)
Amiens, France, 80054
Actively Recruiting
3
CHRU de Besançon - Hôpital Jean Minjoz
Besançon, France, 25030
Active, Not Recruiting
4
CHU Caen Hôpital Côte de Nacre
Caen, France, 14033
Withdrawn
5
CHU Estaing
Clermont-Ferrand, France, 63003
Actively Recruiting
6
APHP - Hôpital Beaujon
Clichy, France, 92110
Actively Recruiting
7
CH Colmar - Hôpital Pasteur
Colmar, France, 68024
Active, Not Recruiting
8
Centre hospitalier de Douai
Douai, France, 59507
Terminated
9
CHRU Lille Hôpital Claude Huriez
Lille, France, 59037
Actively Recruiting
10
APHM - Hôpital Nord
Marseille, France, 13915
Actively Recruiting
11
GHI Le Raincy-Montfermeil
Montfermeil, France, 93370
Actively Recruiting
12
CHU Montpellier - Hôpital Saint Eloi
Montpellier, France, 34295
Actively Recruiting
13
CHU Nantes - Hôpital Hotel Dieu
Nantes, France, 44093
Actively Recruiting
14
CHU Nice- Hopital l'Archet
Nice, France, 62002
Actively Recruiting
15
CHU Nîmes - Hôpital Universitaire Caremeau
Nîmes, France, 30029
Actively Recruiting
16
CHU Bordeaux - Hôpital Haut Lévêque
Pessac, France, 33604
Actively Recruiting
17
CHU Lyon Sud
Pierre-Bénite, France, 69495
Actively Recruiting
18
CHU Rennes Hôpital Pontchaillou
Rennes, France, 35033
Actively Recruiting
19
CH Saint Etienne Hopital Nord
Saint-Priest-en-Jarez, France, 42270
Not Yet Recruiting
20
CH Toulon - CHITS CH Sainte Musse
Toulon, France, 83056
Withdrawn
21
CHU Toulouse - Hôpital Rangueil
Toulouse, France, 31403
Actively Recruiting
22
CH Tourcoing - Hôpital Gustave Dron
Tourcoing, France, 59200
Not Yet Recruiting
23
CHU Nancy - Hôpital de Brabois
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
24
APHP - Hôpital du Kremlin-Bicêtre
Le Kremlin-Bicêtre, Île-de-France Region, France, 94275
Actively Recruiting
Research Team
X
Xavier Hebuterne, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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