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| ID | Type | Description | Link |
|---|---|---|---|
| 91404 | |||
| Novel 3 |
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The purpose of this study is to evaluate whether treatment with Leukine in patients with Crohn's disease who have previously responded to Leukine can be helped again, once they have relapsed.
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 | 6 μg/kg sargramostim administered SC once daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving clinical response or remission | At Day 57 of the randomized retreatment phase |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving clinical response or remission | At the end of Week 8 of the open-label phase. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco | California | 94117 | United States | |||
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| Placebo | Drug | Placebo administered SC once daily during the randomized retreatment phase. |
|
| Atlanta |
| Georgia |
| 30342 |
| United States |
| New Orleans | Louisiana | 70118-5799 | United States |
| Boston | Massachusetts | 02114-2696 | United States |
| Morristown | New Jersey | 07962-1956 | United States |
| Philadelphia | Pennsylvania | 19104-4399 | United States |
| Houston | Texas | 77030 | United States |
| 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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