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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

2019-12-09 00:56:35 | BioPortfolio

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®).

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

Study Design

Conditions

Ulcerative Colitis

Intervention

Adalimumab, Calprotectin, e-Monitoring, Therapy Education

Location

CHU Amiens- Picardie (site Sud)
Amiens
France
80054

Status

Not yet recruiting

Source

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-12-09T00:56:35-0500

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Medical and Biotech [MESH] Definitions

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Inflammation of the COLON that is predominantly confined to the MUCOSA. Its major symptoms include DIARRHEA, rectal BLEEDING, the passage of MUCUS, and ABDOMINAL PAIN.

Chronic, non-specific inflammation of the GASTROINTESTINAL TRACT. Etiology may be genetic or environmental. This term includes CROHN DISEASE and ULCERATIVE COLITIS.

An acute form of MEGACOLON, severe pathological dilatation of the COLON. It is associated with clinical conditions such as ULCERATIVE COLITIS; CROHN DISEASE; AMEBIC DYSENTERY; or CLOSTRIDIUM ENTEROCOLITIS.

A surgical procedure involving the excision of the COLON and RECTUM and the formation of an ILEOANAL RESERVOIR (pouch). In patients with intestinal diseases, such as ulcerative colitis, this procedure avoids the need for an OSTOMY by allowing for transanal defecation.

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