Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

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

A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab (NCT04183608) is a Phase 4 interventional studying Ulcerative Colitis, sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 EW according to patient and/or investigator preference) and azathioprine (2.0/2.5 mg/kg/ day) or methotrexate (25 mg EW) until V3 (W 38). OBJECTIVES: To assess the impact of a treat to target treatment follow up by e-Monitoring and fecal calprotectin dosing at home associated to an appropriate patient education versus standard treatment follow up at W48 in patients requiring a treatment with adalimumab (Humira®).

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 238 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Ulcerative Colitis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Adalimumab

Patients will all receive Adalimumab 160/80/40mg EOW until V1 (W14) followed by 40mg EOW until V2 (W26)

DIAGNOSTIC_TEST

Calprotectin

Fecal calprotectin dosing at home with IBDoc

OTHER

e-Monitoring

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

OTHER

Therapy Education

Patient Education at W0, W2, W14, W26 and W38.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Centre hospitalier de Cholet
Cholet, Maine Et Loire, France
CHU Amiens- Picardie (site Sud)
Amiens, France
CHRU de Besançon - Hôpital Jean Minjoz
Besançon, France
CHU Caen Hôpital Côte de Nacre
Caen, France
CHU Estaing
Clermont-Ferrand, France
APHP - Hôpital Beaujon
Clichy, France
CH Colmar - Hôpital Pasteur
Colmar, France
Centre hospitalier de Douai
Douai, France
CHRU Lille Hôpital Claude Huriez
Lille, France
APHM - Hôpital Nord
Marseille, France
GHI Le Raincy-Montfermeil
Montfermeil, France
CHU Montpellier - Hôpital Saint Eloi
Montpellier, France
CHU Nantes - Hôpital Hotel Dieu
Nantes, France
CHU Nice- Hopital l'Archet
Nice, France
CHU Nîmes - Hôpital Universitaire Caremeau
Nîmes, France
CHU Bordeaux - Hôpital Haut Lévêque
Pessac, France
CHU Lyon Sud
Pierre-Bénite, France
CHU Rennes Hôpital Pontchaillou
Rennes, France
CH Saint Etienne Hopital Nord
Saint-Priest-en-Jarez, France
CH Toulon - CHITS CH Sainte Musse
Toulon, France

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04183608), the sponsor (Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04183608 clinical trial studying?

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 EW according to patient and/or investigator preference) and azathioprine (2.0/2.5 mg/kg/ day) or methotrexate (25 mg EW) until V3 (W 38). OBJECTIVES: To assess the impact of a tr… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04183608?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04183608?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04183608. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04183608. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.