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Raptiva in Palm and Sole Psoriasis

2014-08-27 03:19:31 | BioPortfolio

Summary

The primary purpose of the study is to evaluate the safety and efficacy of Raptiva® compared to placebo in controlling moderate to severe chronic plaque psoriasis involving palms and/or soles scoring PPPASIN5 in subjects that are candidates for phototherapy or systemic therapies.

The rational of the trial is that psoriasis involving palms and/or soles is a painful condition associated with fissuring, scaling and in some instances with pustulation. Because of its localization, it is a disabling condition that limits dexterity and affects social interaction, leading to compromised quality of life; and this confers additional severity to that of plaque psoriasis on the body. The therapeutic approach for palm and sole plaque-type psoriasis usually begins with topical corticosteroid treatment. If the disease reaches a certain extent, the next step involves the addition of systemic treatments. Substances like methotrexate, retinoids and cyclosporine have shown to be efficacious, but their long-term usage is often limited by toxicity. Biologic treatments for psoriasis avoid this toxicity and offer a new therapeutic approach.

The therapeutic potential of Raptiva® to treat palm and sole psoriasis refractory to systemic treatments has been described in numerous case reports and in one placebo-controlled phase IV study. However, in all cases, the number of subjects included was low, and in most cases the trials were not prospectively designed.

Since the efficacy of Raptiva® on psoriasis of palms and soles must be determined using the validated PPPASI measure, it is necessary for scientific and ethical reasons to include a placebo arm during the first 12 weeks. Finally, as the clinical response may sometimes take longer than 12 weeks, subjects must be treated and evaluated during an additional 12-week open-label extended treatment period (4) (11) (12) (13) (14) (15) (16) (17) (18).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Conditions

Chronic Plaque Psoriasis

Intervention

Efalizumab (Raptiva), Placebo

Status

Terminated

Source

Merck KGaA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:31-0400

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RESTORE: Raptiva® (Efalizumab) Evaluation of Safety and Treatment Optimization

RESTORE is an observational, open-label, multi-center, prospective, study enrolling Raptiva® (efalizumab) treated patients with moderate to severe chronic plaque psoriasis. The overall du...

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A Study to Evaluate the Safety of Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2600g

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Therapeutic equivalence of two formulations of calcipotriol-betamethasone ointment: a multi-centre, randomized, double-blind study in adult patients with chronic plaque psoriasis.

Topical agents are the first-line therapy for psoriasis and treatment of choice for mild to moderate chronic plaque psoriasis. Patients with severe psoriasis often use topical therapies at least for s...

Certolizumab Pegol for the Treatment of Chronic Plaque Psoriasis: Results through 48 Weeks from Two Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Studies (CIMPASI-1 and CIMPASI-2).

Certolizumab pegol, the only Fc-Free, PEGylated anti-tumor necrosis factor biologic, demonstrated clinically meaningful improvements and suggested a positive risk-benefit balance in phase 2 studies in...

Tildrakizumab: First Global Approval.

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A review of neurologic complications of biologic therapy in plaque psoriasis.

The use of biologic medications has represented a great advancement in the treatment of moderate to severe plaque psoriasis and has improved patients' quality of life. Despite the increasing popularit...

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 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.

Chronic inflammation and loss of PERIODONTIUM that is associated with the amount of DENTAL PLAQUE or DENTAL CALCULUS present. Chronic periodontitis occurs mostly in adults and was called adult periodontitis, but this disease can appear in young people.

Endovascular procedure in which atheromatous plaque is excised by a cutting or rotating catheter. It differs from balloon and laser angioplasty procedures which enlarge vessels by dilation but frequently do not remove much plaque. If the plaque is removed by surgical excision under general anesthesia rather than by an endovascular procedure through a catheter, it is called ENDARTERECTOMY.

The term applied to a group of relatively uncommon inflammatory, maculopapular, scaly eruptions of unknown etiology and resistant to conventional treatment. Eruptions are both psoriatic and lichenoid in appearance, but the diseases are distinct from psoriasis, lichen planus, or other recognized dermatoses. Proposed nomenclature divides parapsoriasis into two distinct subgroups, PITYRIASIS LICHENOIDES and parapsoriasis en plaques (small- and large-plaque parapsoriasis).

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