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PSC Trial Watch
UCRecruiting

A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab

Phase 4 · Testing Adalimumab, Calprotectin and e-Monitoring · 24 sites · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing Adalimumab (a drug), Calprotectin (a diagnostic test), e-Monitoring and Therapy Education. Condition(s) listed: Ulcerative Colitis.

Participants are assigned to groups by chance (randomized).

It is open-label: participants know what they are receiving.

Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.

Who can join

Some of the main requirements, copied from the record:

Plus 8 more requirement(s). There are also 19 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

Main thing being measured

In the researchers’ words

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…

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Official details

StatusRecruiting
PhasePhase 4
Study typeInterventional
ConditionsUlcerative Colitis
Lead sponsorGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives
CollaboratorsAbbVie
Enrollment238 (estimated)
Start date2020-01-14
Primary completion (est.)2025-04
First posted2019-12-03
Last updated2023-05-31
Official titleAn 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
ClinicalTrials.gov IDNCT04183608

Interventions

Full eligibility criteria (from the record)
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

Locations (24)

SiteCityCountrySite status
CHU Amiens- Picardie (site Sud)AmiensFranceRecruiting
CHRU de Besançon - Hôpital Jean MinjozBesançonFranceActive, not recruiting
CHU Caen Hôpital Côte de NacreCaenFranceWithdrawn
CHU EstaingClermont-FerrandFranceRecruiting
APHP - Hôpital BeaujonClichyFranceRecruiting
CH Colmar - Hôpital PasteurColmarFranceActive, not recruiting
Centre hospitalier de DouaiDouaiFranceTerminated
CHRU Lille Hôpital Claude HuriezLilleFranceRecruiting
APHM - Hôpital NordMarseilleFranceRecruiting
GHI Le Raincy-MontfermeilMontfermeilFranceRecruiting
CHU Montpellier - Hôpital Saint EloiMontpellierFranceRecruiting
CHU Nantes - Hôpital Hotel DieuNantesFranceRecruiting
CHU Nice- Hopital l'ArchetNiceFranceRecruiting
CHU Nîmes - Hôpital Universitaire CaremeauNîmesFranceRecruiting
CHU Bordeaux - Hôpital Haut LévêquePessacFranceRecruiting
CHU Lyon SudPierre-BéniteFranceRecruiting
CHU Rennes Hôpital PontchaillouRennesFranceRecruiting
CH Saint Etienne Hopital NordSaint-Priest-en-JarezFranceNot yet recruiting
CH Toulon - CHITS CH Sainte MusseToulonFranceWithdrawn
CHU Toulouse - Hôpital RangueilToulouseFranceRecruiting
CH Tourcoing - Hôpital Gustave DronTourcoingFranceNot yet recruiting
CHU Nancy - Hôpital de BraboisVandœuvre-lès-NancyFranceRecruiting
Centre hospitalier de CholetCholet, Maine Et LoireFranceActive, not recruiting
APHP - Hôpital du Kremlin-BicêtreLe Kremlin-Bicêtre, Île-de-France RegionFranceRecruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.