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Long-term Safety Extension Study of Apremilast (Cc-10004) in Subjects Who Completed the Treatment Phase of the Extension Study Cc-10004-psor-005e

2014-08-27 03:13:27 | BioPortfolio

Summary

The purpose of this long-term extension study is to assess the safety of dosing with apremilast for up to five years, to see if it continues to improve psoriasis, and how subjects tolerate it.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Psoriasis

Intervention

Apremilast 20 mg, Apremiast 30 mg

Location

Associates In Research Inc.
Fresno
California
United States
93720

Status

Enrolling by invitation

Source

Celgene Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:27-0400

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Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study)

The purpose of this study is to test if the study drug apremilast is safe, if it helps improve psoriasis, and how subjects tolerate it.

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PubMed Articles [355 Associated PubMed Articles listed on BioPortfolio]

Safety and Efficacy of Apremilast Through 104 Weeks in Patients With Moderate to Severe Psoriasis Who Continued on Apremilast or Switched From Etanercept Treatment: Findings From the LIBERATE Study.

Apremilast, an oral phosphodiesterase 4 inhibitor, has demonstrated efficacy in patients with moderate to severe psoriasis.

Efficacy and Safety of Apremilast in Systemic- and Biologic-Naive Patients With Moderate Plaque Psoriasis: 52-Week Results of UNVEIL.

BACKGROUND: Many patients with moderate plaque psoriasis are undertreated despite broadening treatment options. In the phase IV UNVEIL study, oral apremilast demonstrated efficacy and safety in system...

Efficacy and Safety of Apremilast Monotherapy for Moderate to Severe Psoriasis: Retrospective Study.

Apremilast is a new oral drug for the treatment of moderate to severe plaque psoriasis that reduces inflammation by inhibiting phosphodiesterase 4. Its efficacy and safety data are limited; hence, rea...

Synergistic Cytokine Effects as Apremilast Response Predictors in Patients With Psoriasis.

•Based on nonlinear multivariate algorithms, IL-17F is the most important predictor of PASI improvement with apremilast, and nonlinear synergistic cytokine effects are more predictive of PASI respon...

Real-World Clinical Experience With Apremilast in a Large US Retrospective Cohort Study of Patients With Moderate to Severe Plaque Psoriasis.

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Medical and Biotech [MESH] Definitions

A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region. Accelerated epidermopoiesis is considered to be the fundamental pathologic feature in psoriasis.

A glucocorticoid used topically in the treatment of DERMATITIS; ECZEMA; or PSORIASIS. It may cause skin irritation.

A topical anti-inflammatory glucocorticoid used in DERMATOSES, skin allergies, PSORIASIS, etc.

An anthracene derivative that disrupts MITOCHONDRIA function and structure and is used for the treatment of DERMATOSES, especially PSORIASIS. It may cause FOLLICULITIS.

A humanized monoclonal antibody that binds to IL-12 and IL-23 and is used as a DERMATOLOGIC AGENT in the treatment of patients with plaque PSORIASIS who have not responded to other therapies.

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