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Sponsored by: |
Celgene Corporation |
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Information provided by: | Celgene Corporation |
ClinicalTrials.gov Identifier: | NCT00866359 |
The purpose of this study is to assess whether Apremilast is safe and effective in the treatment of patients with Behcet Disease.
Condition | Intervention | Phase |
---|---|---|
Behcet Disease |
Drug: Apremilast (CC-10004) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
Estimated Enrollment: | 156 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
Drug: Apremilast (CC-10004)
Treatment Phase Days 1-7: Titration from 10 mg BID apremilast tablets (or matching placebo) to 30 mg BID apremilast (or matching placebo) Day 8-84: Maintenance of 30 mg BID apremilast (or matching placebo Dose reductions to 20 mg BID (or matching placebo) are permitted. Extension Phase All subjects will be given active drug
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2: Placebo Comparator |
Drug: Apremilast (CC-10004)
Treatment Phase Days 1-7: Titration from 10 mg BID apremilast tablets (or matching placebo) to 30 mg BID apremilast (or matching placebo) Day 8-84: Maintenance of 30 mg BID apremilast (or matching placebo Dose reductions to 20 mg BID (or matching placebo) are permitted. Extension Phase All subjects will be given active drug
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory criteria: Hgb ≥ 9 g/dL, WBC count ≥ 3000 /microL and ≤14,000/microL, platelet count ≥ 100,000
Exclusion Criteria:
Contact: Wayne R Hull, BS | 908-860-7496 | whull@celgene.com |
United States, Florida | |
Mayo Clinic - Rheumatology and Internal Medicine | |
Jacksonville, Florida, United States, 32224 | |
United States, Massachusetts | |
E5, Boston University School of Medicine | |
Boston, Massachusetts, United States, 02118 | |
United States, New York | |
NYU Hospital for Joint Diseases | |
New York, New York, United States, 10003 | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 | |
Turkey | |
University of Istanbul | |
Istanbul, Turkey, 34098 | |
Eskişehir Osmangazi University | |
Eskişehir, Turkey, 26480 | |
Selçuk University | |
Konya, Turkey, 42080 |
Responsible Party: | Celgene Corporation ( Wayne Hull ) |
Study ID Numbers: | CC-10004-BCT-001, EudraCT#: 2008-002722-11 |
Study First Received: | March 18, 2009 |
Last Updated: | March 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00866359 History of Changes |
Health Authority: | United States: Food and Drug Administration; Turkey: The Republic of Turkey Ministry of Health, Pharmaceutical General Directorate Central Ethics Committee |
Panuveitis Uveitis, Anterior Mouth Diseases Behcet Syndrome Uveal Diseases Vasculitis |
Skin Diseases Uveitis Eye Diseases Vascular Diseases Stomatognathic Diseases |
Mouth Diseases Uveitis, Anterior Panuveitis Uveal Diseases Skin Diseases, Vascular Vasculitis Skin Diseases |
Eye Diseases Vascular Diseases Behcet Syndrome Uveitis Cardiovascular Diseases Stomatognathic Diseases |