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study to investigate the safety and efficacy properties of PF-00547659 in patients with active ulcerative colitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.03 mg/kg or placebo iv | Other |
| |
| 0.1 mg/kg or placebo iv | Other |
| |
| 0.3 mg/kg or placebo iv | Other |
| |
| 1.0 mg/kg or placebo iv | Experimental |
| |
| 3.0 mg/kg or placebo sc | Other |
| |
| 10 mg/kg or placebo iv | Other |
| |
| 0.3 mg/kg or placebo sc | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single dose-group A | Biological | PF-00547659, single iv dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and toleration | up to 12 weeks | |
| Endoscopic score changes as calculated using section 3 of the Mayo Score | up to 12 weeks | |
| Disease activity score changes as calculated using the Mayo Score | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of PF-00547659 | up to 12 weeks | |
| Fecal concentrations of calprotectin | up to 12 weeks | |
| Plasma concentrations of CRP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Brussels | 1200 | Belgium | |||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21317177 | Derived | Vermeire S, Ghosh S, Panes J, Dahlerup JF, Luegering A, Sirotiakova J, Strauch U, Burgess G, Spanton J, Martin SW, Niezychowski W. The mucosal addressin cell adhesion molecule antibody PF-00547,659 in ulcerative colitis: a randomised study. Gut. 2011 Aug;60(8):1068-75. doi: 10.1136/gut.2010.226548. Epub 2011 Feb 11. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| 0.1 mg/kg or placebo iv (multiple dose) | Other |
|
| 0.3 mg/kg or placebo iv (multiple dose) | Other |
|
| 3.0 mg/kg or placebo iv | Other |
|
| 0.1 mg/kg or placebo sc | Other |
|
| 0.3 mg/kg or placebo sc (multiple dose) | Other |
|
| Single dose-group A |
| Biological |
PF-00547659, single iv dose |
|
| Multiple dose- Group B | Biological | PF-00547659, multiple dose |
|
| Single dose-group A | Biological | PF-00547659, single iv dose |
|
| Multiple dose- Group B | Biological | PF-00547659, multiple dose |
|
| Single dose-group A | Biological | PF-00547659, single dose |
|
| Single dose-group A | Biological | PF-00547659, single dose |
|
| Single dose-group A | Biological | PF-00547659, single dose |
|
| Single dose-group A | Biological | PF-00547659, single dose |
|
| Multiple dose-Group B | Biological | PF-00547659, multiple dose |
|
| Multiple dose- Group B | Biological | PF-00547659, multiple dose |
|
| Multiple dose- Group B | Biological | PF-00547659, multiple dose |
|
| Multiple dose- Group B | Biological | PF-00547659, multiple dose |
|
| Multiple dose- Group B | Biological | PF-00547659, multiple dose |
|
| Multiple dose-Group B | Biological | PF-00547659, multiple dose |
|
| up to 12 weeks |
| Brussels |
| B-1070 |
| Belgium |
| Pfizer Investigational Site | Leuven | 3000 | Belgium |
| Pfizer Investigational Site | Brno | 625 00 | Czechia |
| Pfizer Investigational Site | Prague | 120 00 | Czechia |
| Pfizer Investigational Site | Prague | 128 01 | Czechia |
| Pfizer Investigational Site | Aarhus C | 8000 | Denmark |
| Pfizer Investigational Site | Berlin | 10117 | Germany |
| Pfizer Investigational Site | Kiel | 24105 | Germany |
| Pfizer Investigational Site | Münster | 48129 | Germany |
| Pfizer Investigational Site | Regensburg | 93042 | Germany |
| Pfizer Investigational Site | Oslo | 0027 | Norway |
| Pfizer Investigational Site | Nitra | 950 01 | Slovakia |
| Pfizer Investigational Site | Barcelona | BARCELONA | 08025 | Spain |
| Pfizer Investigational Site | Barcelona | BARCELONA | 08035 | Spain |
| Pfizer Investigational Site | L'hospitalet DEL Llobregat | BARCELONA | 08907 | Spain |
| Pfizer Investigational Site | Madrid | Madrid | 28040 | Spain |
| Pfizer Investigational Site | Majadahonda | Madrid | 28222 | Spain |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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