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| Name | Class |
|---|---|
| Merck Serono International SA | INDUSTRY |
The purpose of this study is to determine the safety and efficacy of interferon-beta-1a in subjects with active ulcerative colitis (UC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interferon-beta-1a, 44 microgram | Experimental |
| |
| Interferon-beta-1a, 66 microgram | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon-beta-1a, 44 microgram | Drug | Interferon-beta-1a will be administered subcutaneously at a dose of 44 mcg, three times a week up to Week 8. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with endoscopically confirmed remission | Baseline up to Week 12 or early withdrawal or treatment failure |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with clinical remission | Baseline up to Week 12 or early withdrawal or treatment failure | |
| Percentage of subjects with clinical remission at Week 8 and 12 | Week 8 and 12 | |
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Inclusion Criteria:
Moderately active UC, defined as:
At least one previous flare-up of UC
Maintenance treatment with 5-aminosalicylic acid (5-ASA) at a stable dose for the management of UC is allowed, but not required. The daily dose of 5-ASA has to be stable for at least 4 weeks before Study Day 1 and has to be no more than 3.6 gram/day. This dose has to be maintained throughout the study. Corticosteroids will not be allowed during the study, with the exceptions of inhaled steroids and topical dermatological steroids
Age ≥18 years, of either sex
Adequate bone marrow reserve: white blood cells (WBC) greater than (>) 3.5*10^9 per liter (/L), neutrophils >1.5*10 ^9 /L, thrombocytes >100 *10^9 /L, hemoglobin >8.5 gram per deciliter (g/dL)
Female subjects are to be neither pregnant nor breast-feeding and has to lack childbearing potential, as will be defined by either being post-menopausal or surgically sterile or using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide or not pregnant which will be established by a negative serum or urinary Human chorionic gonadotrophin (hCG) test within 7 days before Study Day 1. A pregnancy test is not required if the subject was post-menopausal or surgically sterile
Willingness and ability to comply with the protocol for the duration of the study
Written informed consent, obtained before any study-related procedure not part of the subject's normal medical care, with the understanding that the subject can withdraw consent at any time without prejudice to his or her future medical care
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Pena Rossi, M.D. | Merck Serono International SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Munich | Germany | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19145731 | Result | Pena-Rossi C, Schreiber S, Golubovic G, Mertz-Nielsen A, Panes J, Rachmilewitz D, Shieh MJ, Simanenkov VI, Stanton D, Graffner H. Clinical trial: a multicentre, randomized, double-blind, placebo-controlled, dose-finding, phase II study of subcutaneous interferon-beta-la in moderately active ulcerative colitis. Aliment Pharmacol Ther. 2008 Sep 15;28(6):758-67. doi: 10.1111/j.1365-2036.2008.03778.x. |
| Label | URL |
|---|---|
| Full FDA approved prescribing information can be found here | View source |
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|
| Placebo | Drug | Matching Placebo will be administered subcutaneously, three times a week up to Week 8. |
|
| Interferon-beta-1a, 66 microgram | Drug | Interferon-beta-1a will be administered subcutaneously at a dose of 66 mcg, three times a week up to Week 8. |
|
|
| Time to first occurrence of clinical remission |
| Baseline up to Week 12 or early withdrawal or treatment failure |
| Time to first occurrence of endoscopically confirmed remission | Baseline up to Week 12 or early withdrawal or treatment failure |
| Percentage of subjects with clinical remission two weeks after endoscopically confirmed remission | Baseline up to Week 12 or early withdrawal or treatment failure |
| Percentage of subjects with clinical response | Baseline up to Week 12 or early withdrawal or treatment failure |
| Time to first occurrence of clinical response | Baseline up to Week 12 or early withdrawal or treatment failure |
| Change from Baseline in Ulcerative Colitis Scoring System (UCSS) total score and sub-scores at Week 2, 4, 6, 8 and 12 | Baseline, Week 2, 4, 6, 8 and 12 |
| Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score and sub-scores at Week 4, 8 and 12 | Baseline, Week 4, 8 and 12 |
| Percentage of subjects with an increase in IBDQ score of at least 15 points | Baseline up to Week 12 or early withdrawal or treatment failure |
| Change from Baseline in C-reactive protein level at Week 2, 4, 8 and 12 | Baseline, Week 2, 4, 8 and 12 |
| Changes from Baseline in erythrocyte sedimentation rate at Week 2, 4, 8 and 12 | Baseline, Week 2, 4, 8 and 12 |
| Percentage of subjects with treatment failure | Baseline up to Week 12 or early withdrawal or treatment failure |
| Ness Ziona |
| Israel |
| Research Site | The Hague | Netherlands |
| Research Site | Singapore | Singapore |
| Research Site | Solna | Sweden |
| Research Site | Zug | Switzerland |
| Research Site | Feltham | United Kingdom |
| 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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| ID | Term |
|---|---|
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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