| ID | Type | Description | Link |
|---|---|---|---|
| 91405 | |||
| Novel 4 |
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The purpose of this study is to evaluate if Leukine can induce clinical response or remission in patients with 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 | 6µg/kg SARGRAMOSTIM subcutaneous daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Induction of clinical response and/or remission as defined by decrease in CDAI score | After 8 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time and duration to response/remission | During the 8 weeks of treatment | |
| QoL (different methods) | During the whole study | |
| Safety Profile ( Adverse Event, Serious Adverse Event collection, laboratories especially AB test etc.) |
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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 |
|---|---|---|---|---|---|---|
| Buenos Aires | Buenos Aires F.D. | C1118AAT | Argentina | |||
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| Placebo | Drug | Sterile liquid solution, inactive excipient only subcutaneous daily for 8 weeks |
|
| About 20 months |
| Buenos Aires |
| Buenos Aires F.D. |
| C1264AAA |
| Argentina |
| Garran | Australian Capital Territory | 2605 | Australia |
| Concord | New South Wales | 2139 | Australia |
| New Lambton Heights | New South Wales | 2305 | Australia |
| Sydney | New South Wales | 2050 | Australia |
| Sydney | New South Wales | 2200 | Australia |
| Brisbane | Queensland | 4029 | Australia |
| Brisbane | Queensland | 4101 | Australia |
| Adelaide | South Australia | 5043 | Australia |
| Launceston | Tasmania | 7250 | Australia |
| Ballarat | Victoria | 3350 | Australia |
| Frankston | Victoria | 3199 | Australia |
| Melbourne | Victoria | 3065 | Australia |
| Melbourne | Victoria | 3128 | Australia |
| Parkville | Victoria | 3050 | Australia |
| Prahran | Victoria | 3181 | Australia |
| Fremantle | Western Australia | 6160 | Australia |
| Penrith | 2751 | Australia |
| Salvador | Estado de Bahia | 40110060 | Brazil |
| Curitiba | Paraná | 80060-900 | Brazil |
| Rio de Janeiro | Rio de Janeiro | 21949 900 | Brazil |
| Porto Alegre | Rio Grande do Sul | Brazil |
| São Paulo | São Paulo | 05403-900 | Brazil |
| São Paulo | São Paulo | 05651-901 | Brazil |
| Edmonton | Alberta | T5H 4B9 | Canada |
| Edmonton | Alberta | T6G 2B7 | Canada |
| Kelowna | British Columbia | V1Y 2H4 | Canada |
| Vancouver | British Columbia | V5Z 1H2 | Canada |
| Vancouver | British Columbia | V6Z 2K5 | Canada |
| Victoria | British Columbia | V8R 6T9 | Canada |
| Winnipeg | Manitoba | R3A 1R9 | Canada |
| Hamilton | Ontario | L8N 3Z5 | Canada |
| London | Ontario | N6A 5A5 | Canada |
| Toronto | Ontario | M3N 2V7 | Canada |
| Toronto | Ontario | M5G 1X5 | Canada |
| Windsor | Ontario | N9A 1L9 | Canada |
| Montreal | Quebec | H3A 1A1 | Canada |
| Montreal | Quebec | H3G 1A4 | Canada |
| Montreal | Quebec | H3T 1E2 | Canada |
| Québec | Quebec | G1S 4L8 | Canada |
| Sherbrooke | Quebec | J1G 2E9 | Canada |
| Milford | Auckland | 1309 | New Zealand |
| Christchurch | 8011 | New Zealand |
| Hamilton | 3204 | New Zealand |
| Lipetsk | Russia | 398055 | Russia |
| Moskva | Russia | 105203 | Russia |
| Samara | Russia | 443023 | Russia |
| Moscow | 123154 | Russia |
| Moscow | 129110 | Russia |
| Moskva | 127015 | Russia |
| Volgograd | 400107 | Russia |
| Basel | Basel | 4031 | Switzerland |
| Bern | Canton of Bern | 3010 | Switzerland |
| Lausanne | Canton of Vaud | 1011 | Switzerland |
| Donetsk | 83017 | Ukraine |
| Kharkiv | 61001 | Ukraine |
| Kiev | 03049 | Ukraine |
| Lviv | 49044 | Ukraine |
| Vinnitsa | 26014 | Ukraine |
| Bristol | Avon | BS2 8HW | United Kingdom |
| London | Greater London | W12 0HS | United Kingdom |
| Salford | Greater Manchester | M6 8HD | United Kingdom |
| Edinburgh | Lothian | EH4 2XU | United Kingdom |
| Liverpool | Merseyside | L7 8XP | United Kingdom |
| Harrow | Middlesex | HA1 3UJ | United Kingdom |
| Cardiff | South Glamorgan | CF14 4XW | United Kingdom |
| Newcastle upon Tyne | Tyne and Wear | NE1 4LP | United Kingdom |
| London | WC1E 6AU | United Kingdom |
| Sheffield | S10 2JF | United Kingdom |
| 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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