Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD (BEAT-IBD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03059849|
Recruitment Status : Unknown
Verified February 2017 by McMaster University.
Recruitment status was: Not yet recruiting
First Posted : February 23, 2017
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease Ulcerative Colitis||Drug: Adalimumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||290 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD|
|Estimated Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||May 1, 2018|
|Estimated Study Completion Date :||September 1, 2018|
|Active Comparator: Temporary increase in adalimumab||
Dose of adalimumab will be increased by 40mg every 2 weeks.
|No Intervention: Continued monitoring as per standard of care|
- Number of patients with clinical relapse [ Time Frame: One year ]Clinical relapse will be based on increased clinical symptoms or endoscopic changes requiring use of corticosteroids, addition of an immunomodulator, change to another biologic therapy, or surgery.
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): NCT03059849
|Contact: Cindy James||905 525 9140 ext firstname.lastname@example.org|