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Clinical Trials

Clinical Trials. [Brief] Update. Joseph F. Merola, MD MMSc Director of Clinical Trials, BWH Dermatology 1/9/2014 update on trials for faculty mtg. BWH Dermatology Clinical Trials. Psoriasis. A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of:

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Clinical Trials

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  1. Clinical Trials [Brief] Update Joseph F. Merola, MD MMSc Director of Clinical Trials, BWH Dermatology 1/9/2014 update on trials for faculty mtg

  2. BWH Dermatology Clinical Trials Psoriasis • A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of: • Brodalumab (IL-17 inhibitor) Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis (Amgen) • Closed to enrollment • Thank you for referrals! • Co-I: Stephanie Liu, Abrar Qureshi

  3. BWH Dermatology Clinical Trials Psoriasis • Phase IV: “Open Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects with Moderate to Severe Plaque Psoriasis Who Have Lost a Satisfactory Response to Adalimumab” (Amgen) • Subjects who meet certain eligibility criteria will receive etanercept twice a week for 12 weeks and then once a week for 12 weeks • Study participation includes approximately 9 visits • Study visits every 4 weeks for 24 weeks, plus a follow up phone call 30 days after subject study completion • Lost response to Humira in the past 6 months • Other biologics in the past OK, ustekinumab > 6 months ago • Exclude if adverse event to other biologics • OPEN for enrollment • Co-I: Stephanie Liu, Abrar Qureshi

  4. BWH Dermatology Clinical Trials Psoriatic Arthritis • A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF TOFACITINIB IN SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS AND AN INADEQUATE RESPONSE TO AT LEAST ONE TNF INHIBITOR (Pfizer) • Not yet open to enrollment • (Coming soon: Late winter / early spring 2014)

  5. BWH Dermatology Clinical Trials IIS: Cutaneous Lupus • A phase 0 biomarker pilot study to evaluate the feasibility of using tape harvesting to collect RNA from the upper epidermis of healthy volunteers and subjects with discoid lupus (Biogen IDEC) • Patients with active DLE as well as negative controls (normal skin / healthy volunteers) • Not yet open to enrollment • (Coming soon: Late winter / early spring 2014) • Co-I: Janice Lin, Ruth Ann, Mital, Elena Massarotti

  6. BWH Dermatology Clinical Trials Investigator-Initiated Trials Support • Service for investigators interested in observational and interventional trials • Trial / protocol design • Building a budget • Contract • IRB support • Regulatory monitoring • Navigating and utilizing the CCI • Clinical support (consents, phlebotomy, scheduling etc)

  7. BWH Dermatology Clinical Trials IIS • Trial of Abatacept for Vitiligo (BMS) • Vaneeta Sheth (PI)

  8. BWH Dermatology Clinical Trials In the works… • Atopic Dermatitis (anti IL-4) • Hidradenitis (anti IL-1) • Mital Patel

  9. Clinical Trials Team / Thank You • Mary O’Donnell • Karen Coughlan • Jade Cumberbatch • Helen Kuo • Donna Sullivan • Stephanie Liu • Rob Fuhlbrigge, Alex Gionfriddo • Meghan Hunt, Heather Centauro

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