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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
EU CTIS ID: 2023-507256-76-00
What this study is testing
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®).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- A contraceptive method during the whole trial for childbearing potential female
- Patient familiar with Smartphone and internet use
- 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
You likely can't join if
- People unable to give their consent (because of their physical or mental state).
- Contraindication to anti-TNF therapy including: 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
- Absence of written consent.
See the full eligibility 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
- A contraceptive method during the whole trial for childbearing potential female
- Patient familiar with Smartphone and internet use
- 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)
- Adults with 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.
- People unable to give their consent (because of their physical or mental state).
- Contraindication to anti-TNF therapy including: 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
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.