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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT#: 2007-005832-10 |
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To assess whether a combination of ciprofloxacin and adalimumab is more effective than adalimumab alone for the treatment of perianal fistulas in Crohn's disease
Dutch multicenter, randomized, double-blind study with two arms. 146 patients will be included.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Adalimumab |
|
| 2 | Placebo Comparator | ciprofloxacin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab | Drug | 24 weeks: 160 mg, 80 mg, and than 40mg every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas. | 12 week |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients in remission | 12 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| C.J. van der Woude, MD PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMC | Amsterdam | Netherlands | ||||
| VU |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23525574 | Derived | Dewint P, Hansen BE, Verhey E, Oldenburg B, Hommes DW, Pierik M, Ponsioen CI, van Dullemen HM, Russel M, van Bodegraven AA, van der Woude CJ. Adalimumab combined with ciprofloxacin is superior to adalimumab monotherapy in perianal fistula closure in Crohn's disease: a randomised, double-blind, placebo controlled trial (ADAFI). Gut. 2014 Feb;63(2):292-9. doi: 10.1136/gutjnl-2013-304488. Epub 2013 Mar 23. |
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| ciprofloxacin | Drug | 12 weeks; daily 2 x 500mg |
|
|
| Amsterdam |
| Netherlands |
| Deventer ziekenhuis | Deventer | Netherlands |
| Albert Schweitzer ziekenhuis | Dordrecht | Netherlands |
| Medisch Spectrum Twente | Enschede | Netherlands |
| UMC Gronigen | Groningen | Netherlands |
| LUMC | Leiden | Netherlands |
| AZ Maastricht | Maastricht | Netherlands |
| St Antonius ziekenhuis | Nieuwegein | Netherlands |
| UMC Radboud | Nijmegen | Netherlands |
| Erasmus MC | Rotterdam | Netherlands |
| Haga ziekenhuis | The Hague | Netherlands |
| UMC Utrecht | Utrecht | Netherlands |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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