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Apremilast

Patients with psoriasis vulgaris and patients with psoriatic arthritis who are treated with OTEZLA Tablets

To evaluate the safety and efficacy of OTEZLA in actual clinical settings of use in patients with Psoriasis vulgaris that is with an inadequate response to topical therapies and Psoriasis arthropathica

1. Planned registration period 2 years
2. Planned surveillance period for 4 years from 6 months after launch

Post-Marketing Surveillance Study of OTEZLA

OTEZLA® Tablets Drug Use-Results Survey

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Number of participants with adverse events

General Improvement Rating will be assessed by physician's observation

Visual Analog Scale (VAS) pain will be used for psoriatic arthritis patients' assessment.

PGA: assessment for psoriatic vulgaris by physician to classify disease activity in a consistent manner

The Dermatology Life Quality Index or DLQI is a dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire

Activity for arthritis Baseline is calculated by Disease Activity Score-DAS28 method

Amgen

Crohn Disease

Necrosis

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Fistula

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Inflammatory Bowel Diseases

Gastroenteritis

Dermatologic Agents

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Antibodies

Antibodies, Monoclonal

Immunoglobulins

Infliximab

Immunologic Factors

Tumor Necrosis Factor Inhibitors

monoclonal antibody cA2

Richard Vensel McCloskey

OBJECTIVES:

I. Evaluate the efficacy of chimeric monoclonal antibody (cA2) compared with placebo in closure of enterocutaneous fistulae in patients with Crohn's disease.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to investigational site and number of fistulae (single vs multiple).

Patients are randomized to one of three treatment arms: Arm I: Patients receive an infusion of chimeric monoclonal antibody (cA2) on weeks 0, 2, and 6. Arm II: Patients receive an infusion of cA2 on weeks 0 and 2, and an infusion of placebo on week 6. Arm III: Patients receive an infusion of placebo on day 1 of weeks 0, 2, and 6.

Patients are followed every month for 3 months, then every 6-12 months for up to 2 years.

Phase III Randomized Study of Anti-Tumor Necrosis Factor Chimeric Monoclonal Antibody (cA2) for Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease

Centocor, Inc.

FDA Office of Orphan Products Development

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Post-Marketing Surveillance Study of OTEZLA	NCT03284879	Psoriasis		-	Amgen
Phase III Randomized Study of Anti-Tumor Necrosis Factor Chimeric Monoclonal Antibody (cA2) for Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease	NCT00004941	Crohn's Disease	monoclonal anti...	18 Years - 65 Years	FDA Office of Orphan Products Development
Post-Marketing Surveillance Study of OTEZLA	NCT03284879	Psoriasis		-	Amgen
Phase III Randomized Study of Anti-Tumor Necrosis Factor Chimeric Monoclonal Antibody (cA2) for Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease	NCT00004941	Crohn's Disease	monoclonal anti...	18 Years - 65 Years	FDA Office of Orphan Products Development

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