The purpose of this study is to determine the safety and efficacy of interferon-beta-1a in subjects with active ulcerative colitis (UC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
194
Interferon-beta-1a will be administered subcutaneously at a dose of 44 mcg, three times a week up to Week 8.
Matching Placebo will be administered subcutaneously, three times a week up to Week 8.
Interferon-beta-1a will be administered subcutaneously at a dose of 66 mcg, three times a week up to Week 8.
Research Site
Munich, Germany
Research Site
Ness Ziona, Israel
Research Site
The Hague, Netherlands
Research Site
Singapore, Singapore
Percentage of subjects with endoscopically confirmed remission
Time frame: Baseline up to Week 12 or early withdrawal or treatment failure
Percentage of subjects with clinical remission
Time frame: Baseline up to Week 12 or early withdrawal or treatment failure
Percentage of subjects with clinical remission at Week 8 and 12
Time frame: Week 8 and 12
Time to first occurrence of clinical remission
Time frame: Baseline up to Week 12 or early withdrawal or treatment failure
Time to first occurrence of endoscopically confirmed remission
Time frame: Baseline up to Week 12 or early withdrawal or treatment failure
Percentage of subjects with clinical remission two weeks after endoscopically confirmed remission
Time frame: Baseline up to Week 12 or early withdrawal or treatment failure
Percentage of subjects with clinical response
Time frame: Baseline up to Week 12 or early withdrawal or treatment failure
Time to first occurrence of clinical response
Time frame: 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
Time frame: 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
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Research Site
Solna, Sweden
Research Site
Zug, Switzerland
Research Site
Feltham, United Kingdom
Time frame: Baseline, Week 4, 8 and 12
Percentage of subjects with an increase in IBDQ score of at least 15 points
Time frame: 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
Time frame: Baseline, Week 2, 4, 8 and 12
Changes from Baseline in erythrocyte sedimentation rate at Week 2, 4, 8 and 12
Time frame: Baseline, Week 2, 4, 8 and 12
Percentage of subjects with treatment failure
Time frame: Baseline up to Week 12 or early withdrawal or treatment failure