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| Name | Class |
|---|---|
| University of Southern Denmark | OTHER |
| Hvidovre University Hospital | OTHER |
| Aarhus University Hospital | OTHER |
| AbbVie |
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This study wants to investigate the efficiency of biological treatment for chronic pouchitis. Chronic pouchitis is inflammation in a reconstruction after removal of the colon, a pouch. It is examined in patients with ulcerative colitis.
The primary objective evaluation is to evaluate the clinically effect of biological therapy (adalimumab) in patients with chronic pouchitis.
Secondary objective is to evaluate the effect of biological therapy on the endoscopical and histological inflammatory activity.
It is a double-blinded randomized placebo controlled study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab | Active Comparator | Every second week, mg: 160-80-40-40-40-40 12 weeks in all |
|
| Placebo | Placebo Comparator | Given as the active comparator, every second week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response on treatment with Adalimumab | The number of patients with chronic pouchitis achieving a clinical improvement, defined as a reduction in clinically PDAI ≥ 2 at any time within the 12 weeks of treatment with adalimumab (Humira). Clinical PDAI (0-6 points)(pouchitis disease activity index)refers to fewer (0-1 point), number of bowel movements(0-2 points), rectal bleeding(0-1 point) and fecal urgency(0-2 points). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical improvement after 12 weeks of treatment | The number of patients with a clinical improvement (PDAI reduction ≥ 2)at week 12 See the description of clinical improvement and PDAI under primary endpoint | 12 weeks |
| Clinical remission after 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Kjeldsen, Phd | Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | 5000 | Denmark |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D019449 | Pouchitis |
| ID | Term |
|---|---|
| D003092 | Colitis |
| 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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| INDUSTRY |
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| Drug |
|
The number of patients with pouchitis in remission at week 12 (total PDAI ≤4) |
| 12 weeks |
| Endoscopic and histologic response after treatment with Adalimumab | Effect (reduction in PDAI)of adalimumab (Humira) on the endoscopical and histological activity in chronic pouchitis Endoscopical and histological activity is defined from PDAI (pouchitis disease activity index). Endoscopically the presence of Edema, Granularity, Friability, Loss of vascular pattern, Mucous exudates or Ulceration, gives 1 point each (max 6 points). Histological the presence of polymorphic nuclear leukocyte infiltration and ulceration each gives 1-3 points regarding severity (max 6 points) | 12 weeks |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D007079 | Ileitis |
| D004751 | Enteritis |
| D007077 | Ileal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |