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

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ClinicalTrials.gov Identifier: NCT04183608
Recruitment Status : Recruiting
First Posted : December 3, 2019
Last Update Posted : June 30, 2021
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Brief Summary:

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®).


Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Adalimumab Diagnostic Test: Calprotectin Other: e-Monitoring Other: Therapy Education Phase 4

Detailed Description:

NUMBER OF PATIENTS : 238 patients in 20 sites in France

RECRUITMENT PERIOD : The trial duration for each patient will be 144 weeks

MAIN ENDPOINT : At week 48 success defined by: Endoscopic remission defined by an endoscopic Mayo score 0

SECONDARY ENDPOINTS:

At W48

  • Clinical remission (Clinical remission is defined as a total Mayo score ≤2 points, with no individual sub score >1, and a Mayo endoscopy sub score of 0 or 1)
  • Remission without steroids
  • Endoscopic healing rate with Mayo score 0 or 1
  • UCEIS score
  • Histological healing (Nancy score)
  • Remission rate and remission rate without steroids at study visits and W48
  • Quality of life evolution (evaluate visit W0 vs W14, W26, W38 and W48)
  • Patients satisfaction
  • Continuous response
  • Safety and tolerability
  • Anti-TNF pharmacokinetics
  • Number of visits in trial
  • Number of UC related hospitalizations
  • Number of colectomies
  • Treatment compliance (questionnaire)
  • Patient adhesion (questionnaire)
  • Medico-economic analysis

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : January 14, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Active Comparator: Group Standard of care
In standard of care, patient only visits every 3 months the doctor so the optimization of treatment can be done only at this frequency.
Drug: Adalimumab
Patients will all receive Adalimumab 160/80/40mg EOW until V1 (W14) followed by 40mg EOW until V2 (W26)

Active Comparator: Groupe T2T with telemonitoring and patient education
Treatment with e-Monitoring, home fecal calprotectin testing and therapy education.
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.




Primary Outcome Measures :
  1. Endoscopic Remission [ Time Frame: Week 48 ]

    Treatment success of a treat to target with telemonitoring follow up using e-Monitoring and fecal calprotectin dosing at home associated to an appropriate patient education compared to standard treatment follow up at Week 48.

    Definition of treatment success: Endoscopic remission defined by an endoscopic Mayo score 0



Secondary Outcome Measures :
  1. Efficacy of adalimumab treatment on clinical remission (at Week 48) [ Time Frame: Week 48 ]
    • Remission without steroids:
    • Remission rate and remission rate without steroids at study visits and Week 48

  2. Efficacy of adalimumab treatment on endoscopic Healing (at Week 48) [ Time Frame: Week 48 ]
    Endoscopic healing rate with Mayo score 0 or 1

  3. Efficacy of adalimumab treatment on endoscopic mucosal healing [ Time Frame: Week 48 ]
    UCEIS score

  4. Efficacy of adalimumab treatment on histological Healing (at Week 48) [ Time Frame: Week 48 ]
    Histological healing (Nancy index)

  5. Efficacy of adalimumab treatment on patient quality of life (at Week 48) [ Time Frame: Week 48 ]
    Quality of life evolution (evaluate visit 0 vs -Week 14, Week 26, Week 38 and Week 48)

  6. Patient satisfaction [ Time Frame: Week 48 ]
    Patient satisfaction evaluate with all questionnaires of quality of life

  7. Treatment compliance [ Time Frame: Week 48 ]
    Treatment compliance evaluate at every visit

  8. Patient adhesion [ Time Frame: Week 48 ]
    Patient adhesion evaluate with questionnaire

  9. Disability score evolution [ Time Frame: Week 48 ]
    IBD Disability index, evaluate visit 0 vs - Week 14, Week 26, Week 38 and Week 48

  10. Medico-economic analysis [ Time Frame: Week 48 ]
    Medico-economic comparative analysis between standard of care follow up and tight monitoring follow up

  11. Continuous Clinical Response (CCR) [ Time Frame: Week 48 ]
    Definition: Partial Mayo Response at each visit (Visit 1, Visit 2, Visit 3) with a total Mayo response on Week 48 Visit 4 visit. In the telemonitoring group the partial Mayo limited to questions 1 and 2 will be directly answered by patients themselves through ePRO2 they will score the first 2 questions of partial Mayo from home and send that info to the investigator.

  12. Loss of clinical response [ Time Frame: Week 48 ]
    Pharmacokinetic dosage of Adalimumab (Anti-TNF)

  13. Number of visits in trial [ Time Frame: Week 48 ]
    Number of visits in trial per patients

  14. Colectomies at Week 48 [ Time Frame: Week 48 ]
    Proportion of patients with colectomy

  15. UC related Hospitalizations at Week 48 [ Time Frame: Week 48 ]
    Proportion of UC related hospitalizations



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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) or methotrexate 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 (i.e anti-integrin antibodies) or other biologics known to be effective for UC (approved or investigational)
  • 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

Exclusion Criteria:

  • The patients should not present any of the following 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, including anti-integrin antibodies (approved or investigational), 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04183608


Contacts
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Contact: Xavier Hebuterne, MD PhD 04 92 03 65 75 hebuterne.x@chu-nice.fr

Locations
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Sponsors and Collaborators
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
AbbVie
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Responsible Party: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier: NCT04183608    
Other Study ID Numbers: GETAID-2018-01
First Posted: December 3, 2019    Key Record Dates
Last Update Posted: June 30, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:
IBD
UC
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents