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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temporary increase in adalimumab | Active Comparator |
| |
| Continued monitoring as per standard of care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Drug | Dose of adalimumab will be increased by 40mg every 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |