A Phase 4 interventional study of Adalimumab in Crohn Disease and Ulcerative Colitis, sponsored by McMaster University. Withdrawn. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by McMaster University · Phase 4, Interventional, and Treatment
To examine whether a temporary three month increase in adalimumab dosing will prevent relapse in patients with inflammatory bowel disease in clinical remission who have elevated calprotectin.
Patients using adalimumab for Crohn's disease or ulcerative colitis who are in clinical remission will be followed with fecal calprotectin monitoring every 3 months. Patients with a sustained rise in calprotectin who maintain clinical remission will be offered an opportunity to have an increase in adalimumab for three months. Patients who use the three months of increased adalimumab dosing will be compared to patients who do not use increased dosing to determine if relapse rates differ between these two groups.
1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.
Browse Crohn Disease studies →McMaster University is the lead sponsor of 738 studies on the registry; 125 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
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Exclusion Criteria:
Drug: Adalimumab
Dose of adalimumab will be increased by 40mg every 2 weeks.
Number of patients with clinical relapse
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.
Time frame: One year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2018; primary completion for Feb 2019, 12 months later.
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This study is withdrawn, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Adalimumab