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| ID | Type | Description | Link |
|---|---|---|---|
| 9903 |
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Lack of Efficacy
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The purpose of this study is to determine the safety and efficacy of interferon beta-1a in maintaining remission in patients with Crohn's disease.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon beta-1a | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint was the proportion of patients who maintained remission (relapse-free) and did not receive any additional treatment for the management of Crohn's disease by week 26. |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary efficacy endpoints assessed the effect of treatment with IFN beta 1a on the following measures: | ||
| The proportion of patients who maintained remission (relapse-free) and did not receive any additional treatment for the management of Crohn's disease by week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Pena Rossi, M.D. | EMD Serono | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Information Office | Munich | Germany | ||||
| Medical Information Office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19302707 | Derived | Pena Rossi C, Hanauer SB, Tomasevic R, Hunter JO, Shafran I, Graffner H. Interferon beta-1a for the maintenance of remission in patients with Crohn's disease: results of a phase II dose-finding study. BMC Gastroenterol. 2009 Mar 20;9:22. doi: 10.1186/1471-230X-9-22. |
| Label | URL |
|---|---|
| Full FDA approved prescribing information can be found here | View source |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
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| Time to relapse |
| Change from baseline to end of treatment in Quality of Life (IBDQ) score, CDAI score, biological markers of inflammation (CRP and ESR), number of fistulas (including new fistulas and closure of existing ones), and antibodies to interferon beta-1a. |
| Roma |
| Italy |
| Medical Information Office | Solna | Sweden |
| Medical Information Office | Zug | Switzerland |
| Medical Information Office | Feltham | United Kingdom |
| D007410 | Intestinal Diseases |
| D036341 |
| Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |