Randomized Open-Label Trial Comparing Standard Care Versus Treat-to-Target with Telemonitoring in Ulcerative Colitis Patients Initiating Adalimumab

Trial ID: 2023-507256-76-00
Sponsor: i-GETAID

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Diseases & Conditions

Colitis ulcerative

Objectives

The primary objective of this study is to evaluate the impact of a **treat to target** treatment strategy, which includes e-Monitoring and fecal calprotectin dosing at home, combined with patient education, compared to standard treatment follow-up at week 48 in patients with **ulcerative colitis** initiating treatment with **adalimumab** (Humira®). This objective is clinically relevant as it aims to determine whether a more personalized and proactive approach to treatment can improve patient outcomes in managing ulcerative colitis, a chronic inflammatory bowel disease. The study does not list any secondary objectives.

Participants

The clinical trial involves **adults** aged 18 to 74 years with **moderately-to-severely active ulcerative colitis**. Both male and female participants are included, and the study does not focus on a vulnerable population. Participants are required to have an established diagnosis of ulcerative colitis for at least three months, with a Mayo score of 6-12 points. The trial population was selected based on specific criteria, including an inadequate response to or intolerance of certain medications such as steroids, thiopurines, methotrexate, or vedolizumab. Participants must be naïve to anti-TNF therapy and other biologics, except vedolizumab, and JAK inhibitors. They should be familiar with smartphone and internet use, as the study involves e-Monitoring. Female participants of childbearing potential are required to use a contraceptive method throughout the trial. The sponsor did not provide information on the total number of participants.

Plans and Procedures

The clinical trial is designed as an **open-label randomized** study comparing standard care with a treat-to-target approach, incorporating telemonitoring and patient education for individuals with **ulcerative colitis** initiating treatment with **adalimumab**. The trial aims to evaluate the impact of this approach on treatment outcomes over a period of 48 weeks. Participants will be randomly assigned to either the standard care group or the treat-to-target group, with the latter receiving additional support through e-monitoring and fecal calprotectin dosing at home.

The trial will commence with an inclusion visit, where participants will be screened based on specific criteria, including age, disease severity, and previous treatment history. Eligible participants are adults aged 18 to 74 years with moderately-to-severely active ulcerative colitis, who have not responded adequately to previous treatments such as steroids or thiopurines. Participants must also be familiar with smartphone and internet use, as these tools are integral to the telemonitoring component of the study.

Following the inclusion visit, participants will attend regular follow-up visits at weeks 14, 26, 38, and 48. These visits will assess various endpoints, including endoscopic remission, clinical remission, and quality of life. The primary endpoint is defined as endoscopic remission at week 48, characterized by an endoscopic Mayo score of 0. Secondary endpoints include clinical remission, remission without steroids, and histological healing, among others. The end-of-study visit will occur at week 48, marking the conclusion of the participant's involvement in the trial.

Participant involvement is expected to last for the entire 48-week duration of the trial, unless early termination is warranted. Conditions that may lead to early termination include adverse events, non-compliance with the study protocol, or withdrawal of consent. The trial is anticipated to conclude by September 2028, with recruitment having started in January 2020. The study is categorized as a phase IV trial, indicating its focus on post-marketing surveillance and the evaluation of treatment strategies in a real-world setting.

Treatment

The clinical trial involves the administration of **adalimumab**, marketed under the name Humira, as the experimental medication. Humira is provided as a 40 mg **solution for injection** in a pre-filled syringe. The pharmaceutical form is specifically designed for **subcutaneous injection**. The maximum daily dose of adalimumab is 160 mg, with a total maximum dose of 160 mg over the treatment period. The treatment duration is set for a maximum of 48 weeks. The administration schedule and dosing frequency are determined based on the trial protocol, ensuring adherence to the specified treatment regimen. Participant compliance with the dosing schedule is monitored throughout the study to ensure accurate assessment of the treatment's efficacy and safety.

In addition to the experimental treatment, the study includes a standard-of-care therapy as a comparator. This involves a conventional treatment follow-up for patients with **ulcerative colitis** who are initiating adalimumab therapy. The trial aims to compare the outcomes of the standard treatment follow-up with a treat-to-target approach, which incorporates telemonitoring and patient education. The standard-of-care therapy serves as a control to evaluate the impact of the experimental treatment strategy on patient outcomes. Compliance with the standard treatment regimen is also monitored to ensure consistency and reliability of the trial results.

Efficacy

Efficacy in this clinical trial will be assessed through a series of primary and secondary endpoints. The primary endpoint is defined as endoscopic remission at week 48, characterized by an endoscopic Mayo score of 0. Secondary endpoints include clinical remission, which is defined as a total Mayo score of ≤ 2 points with no individual subscore greater than 1, and a Mayo endoscopy subscore of 0 or 1. Additional secondary endpoints encompass remission without steroids, endoscopic healing rate with a Mayo score of 0 or 1, **UCEIS** score, histological healing as measured by the Nancy score, and remission rates at study visits and week 48.

Quality of life will be evaluated by comparing baseline to weeks 14, 26, 38, and 48. Other secondary measures include patient satisfaction, continuous response, safety and tolerability, anti-TNF pharmacokinetics, and the number of visits, hospitalizations, and colectomies related to ulcerative colitis. Treatment compliance and patient adhesion will be assessed through questionnaires, and a medico-economic analysis will be conducted. These efficacy parameters will be collected and analyzed at specified timepoints throughout the trial to determine the impact of the treatment regimen.

Inclusion and Exclusion Criteria

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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)
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.
A contraceptive method during the whole trial for childbearing potential female
Patient familiar with Smartphone and internet use

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Exclusion Criteria

People 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 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