Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab (CURE)
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|ClinicalTrials.gov Identifier: NCT03306446|
Recruitment Status : Active, not recruiting
First Posted : October 11, 2017
Last Update Posted : January 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|CD||Drug: Start adalimumab in monotherapy||Phase 4|
The main objective will be to evaluate the sustained deep remission rate one year after discontinuation of a 12 month course of adalimumab in adult patients with early CD who have achieved deep remission at 12 months AND who were already in clinical remission (CDAI < 150) and biomarker remission (CRP < 5 mg/L and fecal calprotectin < 250) at 6 months. The study will also address several questions:
- What is the rate of deep remission after a 12-month course of adalimumab in early CD patients?
- What is the rate of deep remission 12 months after adalimumab discontinuation in patients with deep remission after a 12-month course of adalimumab (thus defining sustained deep remission) AND who were already in clinical remission (CDAI < 150) and biomarker remission (CRP < 5 mg/L and fecal calprotectin < 250) at 6 months?
- What are the consequences of a treatment with adalimumab on the natural course of CD and long-term clinical outcomes (bowel damage, CD related surgeries and hospitalization, and patient-reported outcomes)? Therefore the study will give information on the effect of a 12-month course of adalimumab in early CD patients, impact of "drug holiday" after deep remission has been achieved, and long term effect of adalimumab on early CD course (relapses, CD-related surgery and hospitalizations, bowel damage, and patient-reported outcomes). The study will also assess predictors of loss of deep remission at 2-year evaluation in patients who achieved 1-year deep remission. Efficacy and tolerability of adalimumab will be assessed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||203 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab|
|Actual Study Start Date :||March 17, 2015|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2025|
Experimental: Adalimumab in monotherapy
Start Adalimumab in monotherapy at 160 mg at inclusion, 80 mg on 2nd week and 40 mg/week each other week over 12 months.
Drug: Start adalimumab in monotherapy
Discontinuation of Adalimumab in patients who achieved deep remission
Other Name: begin humira in monotherapie in Early crohn disease patient
- Sustained deep remission rate [ Time Frame: 12 months ]Number of patients with sustained deep remission at one year
- 2-year deep remission rate [ Time Frame: 2 years ]Number of patients with 2-year deep remission rate among patients who did not achieve 1-year remission
- Impact of an early treatment with adalimumab on long-term clinical outcomes [ Time Frame: 5 years ]Frequency and severity of adverse events in patients followed for 5 years
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): NCT03306446
|Principal Investigator:||Yoram Bouhnik, MD||Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives|
|Principal Investigator:||Laurent Peyrin-Biroulet, MD, PhD||Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives|