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
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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…
- Age ≥ 18 years and < 75 years
- Patients scheduled to start a treatment with adalimumab
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
- About 238 participants are expected to take part.
- Start date: 2020-01-14.
- Main results expected around 2025-04 (estimate from the record).
- 24 study sites listed (16 marked recruiting) in France.
Main thing being measured
- Endoscopic Remission (Week 48)
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
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
| Collaborators | AbbVie |
| Enrollment | 238 (estimated) |
| Start date | 2020-01-14 |
| Primary completion (est.) | 2025-04 |
| First posted | 2019-12-03 |
| Last updated | 2023-05-31 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT04183608 |
Interventions
- Adalimumab (Drug)
Patients will all receive Adalimumab 160/80/40mg EOW until V1 (W14) followed by 40mg EOW until V2 (W26) - Calprotectin (Diagnostic Test)
Fecal calprotectin dosing at home with IBDoc - e-Monitoring (Other)
e-Monitoring at Week 6, Week 10, Week 14, Week 18, Week 22, Week 26, Week 34, Week 38, Week 42 and Week 48 The patient must complete the first 2 questions of the Mayo score: * Stool frequency * The frequency of bleeding He must also complete the information on his injections - Therapy Education (Other)
Patient Education at W0, W2, W14, W26 and W38.
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)
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens- Picardie (site Sud) | Amiens | France | Recruiting |
| CHRU de Besançon - Hôpital Jean Minjoz | Besançon | France | Active, not recruiting |
| CHU Caen Hôpital Côte de Nacre | Caen | France | Withdrawn |
| CHU Estaing | Clermont-Ferrand | France | Recruiting |
| APHP - Hôpital Beaujon | Clichy | France | Recruiting |
| CH Colmar - Hôpital Pasteur | Colmar | France | Active, not recruiting |
| Centre hospitalier de Douai | Douai | France | Terminated |
| CHRU Lille Hôpital Claude Huriez | Lille | France | Recruiting |
| APHM - Hôpital Nord | Marseille | France | Recruiting |
| GHI Le Raincy-Montfermeil | Montfermeil | France | Recruiting |
| CHU Montpellier - Hôpital Saint Eloi | Montpellier | France | Recruiting |
| CHU Nantes - Hôpital Hotel Dieu | Nantes | France | Recruiting |
| CHU Nice- Hopital l'Archet | Nice | France | Recruiting |
| CHU Nîmes - Hôpital Universitaire Caremeau | Nîmes | France | Recruiting |
| CHU Bordeaux - Hôpital Haut Lévêque | Pessac | France | Recruiting |
| CHU Lyon Sud | Pierre-Bénite | France | Recruiting |
| CHU Rennes Hôpital Pontchaillou | Rennes | France | Recruiting |
| CH Saint Etienne Hopital Nord | Saint-Priest-en-Jarez | France | Not yet recruiting |
| CH Toulon - CHITS CH Sainte Musse | Toulon | France | Withdrawn |
| CHU Toulouse - Hôpital Rangueil | Toulouse | France | Recruiting |
| CH Tourcoing - Hôpital Gustave Dron | Tourcoing | France | Not yet recruiting |
| CHU Nancy - Hôpital de Brabois | Vandœuvre-lès-Nancy | France | Recruiting |
| Centre hospitalier de Cholet | Cholet, Maine Et Loire | France | Active, not recruiting |
| APHP - Hôpital du Kremlin-Bicêtre | Le Kremlin-Bicêtre, Île-de-France Region | France | Recruiting |
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.