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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

ConditionUlcerative Colitis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives

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®).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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 intervention

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

Treatment groups

238 Participants
are divided into 2 treatment groups
Group A: Group Standard of careActive comparator 1 intervention
Group B: Groupe T2T with telemonitoring and patient educationActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Endoscopic Remission

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

Time frame
Week 48

Secondary outcomes

1

Efficacy of adalimumab treatment on clinical remission (at Week 48)

* Remission without steroids: * Remission rate and remission rate without steroids at study visits and Week 48

Time frame
Week 48
2

Efficacy of adalimumab treatment on endoscopic Healing (at Week 48)

Endoscopic healing rate with Mayo score 0 or 1

Time frame
Week 48
3

Efficacy of adalimumab treatment on endoscopic mucosal healing

UCEIS score

Time frame
Week 48
4

Efficacy of adalimumab treatment on histological Healing (at Week 48)

Histological healing (Nancy index)

Time frame
Week 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Lead sponsor

AbbVie

Collaborator

Source ClinicalTrials.gov
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