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| ID | Type | Description | Link |
|---|---|---|---|
| 91282 | |||
| Novel 2 |
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The purpose of this study is to evaluate the effectiveness of Leukine to decrease the need for steroid treatment for Crohn's disease.
On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sargramostim (Leukine) | Drug | Once daily via subcutaneous injection for up 22 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Corticosteroid-free remission | At the end of the study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Steroid-free remission or response to treatment as defined by the protocol | At the end of the study treatment | |
| Quality of Life using Inflammatory Bowel Disease Questionaire, SF 36 and EuroQol-derived visual scale (VAS) | At the end of the study treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19505878 | Derived | Valentine JF, Fedorak RN, Feagan B, Fredlund P, Schmitt R, Ni P, Humphries TJ. Steroid-sparing properties of sargramostim in patients with corticosteroid-dependent Crohn's disease: a randomised, double-blind, placebo-controlled, phase 2 study. Gut. 2009 Oct;58(10):1354-62. doi: 10.1136/gut.2008.165738. Epub 2009 Jun 7. |
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| Placebo | Drug | Once daily via subcutaneous injection for up 22 weeks |
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| 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 |
|---|---|
| C081222 | sargramostim |
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