An open-label randomized trial COmparing staNdard of care versus Treat to target with telemonitoRing and patient education in patients with ulcerative cOlitis initiating adalimumab : The CONTROL trial

Phase 1

• Conditions: lcerative Colitis; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856

• Registration Number: EUCTR2018-003490-10-FR
• Lead Sponsor: GETAID

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-26
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

-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) or methotrexate 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 (i.e anti-integrin antibodies) or other biologics known to be effective for UC (approved or investigational)
-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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 238
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 238

Exclusion Criteria

-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, including anti-integrin antibodies (approved or investigational), 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:
oActive infection.
oNon-treated latent tuberculosis.
oHeart failure (NYHA: Grade III and IV).
oMalignancy during the previous 5 years.
oDemyelinating neurological disease.
oCurrent 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified