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| Sponsor: | Celgene Corporation |
|---|---|
| Information provided by (Responsible Party): | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT00866359 |
Purpose
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 Syndrome |
Drug: Apremilast (CC-10004) Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Followed by an Active-Treatment Extension to Evaluate the Efficacy and Safety of Apremilast(CC-10004) in the Treatment of Behçet Disease |
| Estimated Enrollment: | 156 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: A. Apremilast |
Drug: Apremilast (CC-10004)
Treatment Phase Days 1-7: Titration from 10 mg BID apremilast tablets arm A (or matching placebo arm B) to 30 mg BID apremilast arm A(or matching placebo arm B) Day 8-84: Maintenance of 30 mg BID apremilast arm A (or matching placebo arm B) Dose reductions to 20 mg BID apremilast arm A (or matching placebo arm B) are permitted. Extension Phase All subjects will be given active drug Days 85-91: All placebo subjects from Treatment phase will be dose titrated from 10 mg BID apremilast tablets arm A to 30 mg BID Apremilast. Day 92-169: Maintenance of 30 mg BID apremilast arm A or dose reductions to 20 mg BID apremilast arm A (if not previously down titrated) |
| Placebo Comparator: B. Placebo Comparator |
Drug: Placebo
Treatment Phase Days 1-7: Titration from 10mg BID matching placebo (arm B) to 30mg BID placebo (arm B) Day 8-84: Maintenance of 30mg BID placebo (arm B). Dose reductions to 20 mg BID matching placebo (arm B) are permitted. Extension Phase All subjects will be given active drug Days 85-91: All placebo subjects from Treatment phase will be dose titrated from 10 mg BID apremilast tablets arm A to 30 mg BID Apremilast. Day 92-169: Maintenance of 30 mg BID apremilast or dose reductions to 20 mg BID apremilast (if not previously down titrated) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | |
| Eskişehir Osmangazi University | |
| Eskişehir, Turkey, 26480 | |
| University of Istanbul | |
| Istanbul, Turkey, 34098 | |
| Selçuk University | |
| Konya, Turkey, 42080 | |
| Principal Investigator: | Yusuf Yazici, MD | NYU Hospital for Joint Diseases |
More Information
| Responsible Party: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT00866359 History of Changes |
| Other Study ID Numbers: | CC-10004-BCT-001, EudraCT#: 2008-002722-11 |
| Study First Received: | March 18, 2009 |
| Last Updated: | May 1, 2012 |
| Health Authority: | United States: Food and Drug Administration Turkey: Ministry of Health |
|
Behcet Syndrome Mouth Diseases Stomatognathic Diseases Uveitis, Anterior Panuveitis Uveitis Uveal Diseases |
Eye Diseases Vasculitis Vascular Diseases Cardiovascular Diseases Skin Diseases, Vascular Skin Diseases |