Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab
NCT03306446 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 203
Last updated 2023-05-31
Summary
This is a prospective, longitudinal, multicenter study conducted in a cohort of patients with early CD. This study will not change the patient/physician relationship.
Conditions
Interventions
- DRUG
-
Start adalimumab in monotherapy
Discontinuation of Adalimumab in patients who achieved deep remission
Sponsors & Collaborators
-
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
lead OTHER
Principal Investigators
-
Yoram Bouhnik, MD · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
-
Laurent Peyrin-Biroulet, MD, PhD · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-03-17
- Primary Completion
- 2021-03-31
- Completion
- 2025-03-31
Countries
- Belgium
- France
Study Locations
More Related Trials
-
Adalimumab on Preventing Post-chirurgic Recurrence on Crohn´s Disease
NCT01564823 ·Status: COMPLETED ·Phase: PHASE3
-
An Observational Study of Fecal Calprotectin as Clinical Tool in Monitoring Moderate-to-severe Crohn's Disease on Adalimumab Induction Therapy: a KoRean Experience (FAIR)
NCT01759264 ·Status: COMPLETED
-
Remission in Subjects With Crohn's Disease, Open Label Extension
NCT01070303 ·Status: COMPLETED ·Phase: PHASE3
-
Effects of Adalimumab on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon
NCT00348283 ·Status: COMPLETED ·Phase: PHASE3
-
Early Immunosuppressants in Crohn's Disease
NCT00546546 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease
NCT00409682 ·Status: COMPLETED ·Phase: PHASE3
-
Adalimumab-psoriasis and Small Bowel Lesions
NCT01556672 ·Status: COMPLETED ·Phase: PHASE4
-
Open-Label Adalimumab for Ulcerative Colitis Patients
NCT00421642 ·Status: COMPLETED ·Phase: PHASE1
-
Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
NCT00105300 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
NCT00055523 ·Status: COMPLETED ·Phase: PHASE2
-
Interest of the Dosage of Adalimumab Serum Levels in Crohn's Disease Patients for Prevention of Postoperative Recurrence
NCT04200547 ·Status: TERMINATED ·Phase: NA
-
A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
NCT03017014 ·Status: TERMINATED
-
Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD
NCT03059849 ·Status: WITHDRAWN ·Phase: PHASE4
-
Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)
NCT00427921 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease
NCT02065570 ·Status: COMPLETED ·Phase: PHASE3
-
Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study
NCT02450513 ·Status: COMPLETED
-
Adalimumab for the Management of Post-operative Crohn's Disease (CD)
NCT01629628 ·Status: UNKNOWN ·Phase: PHASE3
-
Lengthening Adalimumab Dosing Interval in Quiescent Crohn's Disease Patients
NCT03172377 ·Status: UNKNOWN ·Phase: PHASE4
-
Predictive Factors of ANTI-TNF Response in Luminal Crohn's Disease Complicated by Abscess
NCT02856763 ·Status: COMPLETED
-
Switching From Adalimumab to Infliximab
NCT01338740 ·Status: COMPLETED
-
Assessing Effectiveness of Adalimumab for Treating Ulcerative Colitis in Real Life Conditions
NCT02738125 ·Status: COMPLETED
-
A Study of Subcutaneous HUMIRA (Adalimumab) Injection to Assess Adverse Events and Change in Disease Activity In Adult Participants With Moderate to Severe Active Crohn's Disease (CD)
NCT05394805 ·Status: COMPLETED
-
Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis
NCT02065622 ·Status: COMPLETED ·Phase: PHASE3
-
Open Label Study to Evaluate Long Term Efficacy, Safety and Tolerability of Repeated Dosing in Subjects With Crohn's Disease and Who Participated and Successfully Completed M14-115
NCT02185014 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's Disease
NCT02499783 ·Status: COMPLETED ·Phase: PHASE3