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Comparing standard care with targeted treatment and monitoring for ulcerative colitis patients starting adalimumab

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 4 Interventional Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · NCT04183608

This study is testing if a new approach that includes extra monitoring and education can help adults with moderate to severe ulcerative colitis feel better when they start treatment with adalimumab, compared to standard care.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment238 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives Academic / other
Drugs / interventionsvedolizumab, adalimumab, methotrexate, prednisone
Locations24 sites (Cholet, Maine Et Loire and 23 other locations)
Trial IDNCT04183608 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a targeted treatment approach combined with telemonitoring and patient education against standard care in adults with moderate to severe ulcerative colitis initiating adalimumab therapy. The study involves a randomized, open-label design across multiple centers in France, enrolling 238 patients. Participants will receive adalimumab and may have their treatment optimized based on their response, with follow-up assessments including endoscopic and clinical remission rates at 48 weeks. The trial aims to determine if enhanced monitoring and education can improve patient outcomes compared to standard treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with moderately to severely active ulcerative colitis who are starting treatment with adalimumab and have not previously responded to other therapies.

Not a fit: Patients who have previously received anti-TNF therapy or JAK inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to better management and improved remission rates for patients with ulcerative colitis.

How similar studies have performed: Other studies have shown promising results with similar targeted treatment and monitoring approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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), 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 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 (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

Where this trial is running

Cholet, Maine Et Loire and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ulcerative ColitisIBDUC
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.