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 · Type: OBSERVATIONAL · Enrollment: 62
Last updated 2020-10-08
Summary
The primary objective of this study is to evaluate long-term effectiveness of adalimumab in pediatric participants starting a treatment for Crohn's disease in real life conditions, namely to describe the time to loss of clinical benefit in a time to event approach. Main secondary objectives are to describe growth and pubertal development and to describe long-term safety. The participants will be followed-up up to 10 years.
Conditions
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
AbbVie Inc. · AbbVie
Eligibility
- Min Age
- 6 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-09-26
- Primary Completion
- 2019-10-14
- Completion
- 2019-10-14
Countries
- France
Study Locations
More Related Trials
-
Study of Adalimumab Treatment for Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease
NCT00409617 ·Status: COMPLETED ·Phase: PHASE3
-
Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease
NCT00077779 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
NCT04673357 ·Status: COMPLETED ·Phase: PHASE3
-
Reduce Risk for Crohn's Disease Patients
NCT02852694 ·Status: COMPLETED ·Phase: PHASE4
-
Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease
NCT00195715 ·Status: COMPLETED ·Phase: PHASE3
-
Lengthening Adalimumab Dosing Interval in Quiescent Crohn's Disease Patients
NCT03172377 ·Status: UNKNOWN ·Phase: PHASE4
-
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
NCT02065557 ·Status: COMPLETED ·Phase: PHASE3
-
Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study
NCT02450513 ·Status: COMPLETED
-
Remission in Subjects With Crohn's Disease, Open Label Extension
NCT01070303 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Test Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Crohn's Disease
NCT04643483 ·Status: WITHDRAWN ·Phase: PHASE3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
-
Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD
NCT03059849 ·Status: WITHDRAWN ·Phase: PHASE4
-
Efficacy and Safety of Two Regimens of Maintenance Therapy in Children With Crohn Disease
NCT01559142 ·Status: UNKNOWN ·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
-
A Study of Abatacept in Patients With Active Crohn's Disease
NCT00406653 ·Status: TERMINATED ·Phase: PHASE3
-
Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis
NCT02632175 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease
NCT00055367 ·Status: COMPLETED ·Phase: PHASE2
-
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
-
Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease
NCT02065570 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase I Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients With Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn's Disease
NCT03478956 ·Status: TERMINATED ·Phase: PHASE1
-
Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
NCT06332534 ·Status: RECRUITING ·Phase: PHASE3
-
Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
NCT02403323 ·Status: TERMINATED ·Phase: PHASE3
-
A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease
NCT04102111 ·Status: TERMINATED ·Phase: PHASE2
-
A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's Disease
NCT04655807 ·Status: WITHDRAWN ·Phase: PHASE2
-
Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year
NCT03464136 ·Status: COMPLETED ·Phase: PHASE3