Status:
RECRUITING
A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab
Lead Sponsor:
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Collaborating Sponsors:
AbbVie
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
NUMBER OF PATIENTS : 238 patients in 20 sites in France RECRUITMENT PERIOD : The trial duration for each patient will be 144 weeks MAIN ENDPOINT : At week 48 success defined by: Endoscopic remission...
Eligibility Criteria
Inclusion
- Adults with moderately-to-severely active Ulcerative Colitis (UC) who had an inadequate response to or failed to tolerate steroids and thiopurines (azathioprine or 6-mercaptopurine), methotrexate or vedolizumab or adults with moderately-to-severely active UC who had no response to an adequate steroid course
- Age ≥ 18 years and \< 75 years
- Patients scheduled to start a treatment with adalimumab
- Naïve to anti-TNF therapy and other biologics known to be effective for UC (approved or investigational) except for vedolizumab
- Naïve to JAK inhibitors (approved or investigational)
- Moderately-to-severely active UC for at least 3 months with a Mayo score of 6-12 points (endoscopy subscore of at least 2)
- Established diagnosis of UC for at least 3 months (pancolitis, left-sided colitis, proctosigmoiditis and proctitis are allowed).
- Patient has to be treated with oral 5-ASA at time of inclusion regardless of the dose if no contra-indication.
- Azathioprine, 6-mercaptopurine or methotrexate will be stopped two weeks before inclusion.
- A contraceptive method during the whole trial for childbearing potential female
- Patient familiar with Smartphone and internet use
Exclusion
- Patients unable to give their consent (because of their physical or mental state).
- Absence of written consent.
- Pregnancy or breastfeeding.
- Patients with severe acute colitis or patients at imminent risk for colectomy.
- History of colectomy.
- History of colonic mucosal dysplasia or adenomatous colonic polyps that are not removed.
- Screening stool trial positive for enteric pathogens or Clostridium difficile toxin.
- Oral corticosteroids at a dose \> 40 mg prednisone or its equivalent per day at inclusion (oral steroids should be at stable dose at least 7 days before inclusion)
- Any current or previous use of cyclosporine, tacrolimus, anti-TNF therapy, and other biologics (except vedolizumab), JAK inhibitors (approved or investigational), or any current or previous use of an investigational agent within 5 half-lives of that agent before the first trial agent injection.
- Contraindication to anti-TNF therapy according to drug labeling:
- Active infection.
- Non-treated latent tuberculosis.
- Heart failure (NYHA: Grade III and IV).
- Malignancy during the previous 5 years.
- Demyelinating neurological disease.
- Current or recent (less than 4 weeks) vaccination with attenuated live vaccines
- Patients with a dominant arm deficiency or physical impairment impeding the achievement of the tests
- Patients using a prohibited medication
- Patients participating in another trial or being in a follow-up period for another trial
Key Trial Info
Start Date :
January 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT04183608
Start Date
January 14 2020
End Date
May 1 2028
Last Update
May 31 2023
Active Locations (24)
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1
Centre hospitalier de Cholet
Cholet, Maine Et Loire, France, 49300
2
CHU Amiens- Picardie (site Sud)
Amiens, France, 80054
3
CHRU de Besançon - Hôpital Jean Minjoz
Besançon, France, 25030
4
CHU Caen Hôpital Côte de Nacre
Caen, France, 14033