A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab
Recruiting
Phase 4
Interventional Study
Ulcerative Colitis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 238 (estimated)
- Sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Other
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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 u…
Trial Locations
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Eligibility 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), methotrexate or vedolizumab or adults with moderately-to-severely active UC who had no respons…
Contacts