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Documentation of Humira in Psoriasis Patients in Routine Clinical Practice

2014-08-27 03:15:35 | BioPortfolio

Summary

Safety and Effectiveness of adalimumab (Humira) in Psoriasis Patients in Routine Clinical Practice.

Description

Postmarketing Observational Study to Evaluate the Work Productivity, Safety and Efficacy of Humira for the Treatment of Moderate to Severe Plaque Psoriasis in Daily Clinical Practice.The primary objectives of the PMOS are to explore changes in health related care utilization data by the evaluation of:

- the number of missed working days

- the number of visits to doctor's office

- the number and duration of hospitalizations

- work ability to assess efficacy for different subgroups by

- the number of patients achieving a PASI 75 response to evaluate safety by

- the documentation and analysis of adverse events for all patients and subgroups with concomitant diseases Secondary objectives include the exploration of changes in quality of life measurements, of the influence of age, gender and duration of disease

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Conditions

Moderate to Severe Plaque Psoriasis

Intervention

adalimumab (Humira)

Location

Site Reference ID/Investigator# 35037
Aachen
Germany
52074

Status

Recruiting

Source

Abbott

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:35-0400

Clinical Trials [2238 Associated Clinical Trials listed on BioPortfolio]

Comparative Clinical Trial of Efficacy and Safety of BCD-057 and Humira® in Patients With Moderate to Severe Plaque Psoriasis

CALYPSO clinical study is a phase 3 study which is carried out to establish the efficacy, safety and pharmacokinetic equivalence of BCD-055 (adalimumab, manufactured by JSC BIOCAD, Russia)...

MSB11022 in Moderate to Severe Chronic Plaque Psoriasis

The purpose of this study is to demonstrate equivalence in efficacy and to compare the safety and immunogenicity of an investigational medication called MSB11022 with Humira® in people wi...

MYL-1401A Efficacy and Safety Comparability Study to Humira®

To assess the equivalence of MYL-1401A to Humira® with regards to efficacy in subjects with moderate-to-severe chronic plaque psoriasis

Study of Efficacy and Safety of HLX03 in Subjects With Moderate to Severe Plaque Psoriasis

This is a multicenter, randomized, double-blind, positive drug parallel-group controlled clinical study in China to evaluate efficacy, safety, tolerability and immunogenicity of HLX03 and ...

A Post Marketing Observational Study (PMOS) of the Quality of Life in Adalimumab Treated Psoriasis Patients Failing Other Biological Disease Modifying Anti-rheumatic Drugs (BDMARDs) Over 1 Year

The aim of this PMOS is to obtain further data on long-term safety, efficacy and the evaluation of quality of life outcomes of the HUMIRA-Pen in routine clinical use in patients with Moder...

PubMed Articles [7225 Associated PubMed Articles listed on BioPortfolio]

Long-Term Optimization of Outcomes With Flexible Adalimumab Dosing in Patients With Moderate to Severe Plaque Psoriasis.

The recently updated dosing recommendation for adalimumab for moderate to severe plaque psoriasis states that patients with inadequate response to adalimumab every other week (EOW) after 16 weeks may ...

Psoriasis Area and Severity Index (PASI) response in moderate-severe psoriatic patients switched to adalimumab: results from the OPPSA study.

Few studies have compared the efficacy of switching to adalimumab in the real-life setting in plaque psoriasis patients.

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...

Safety of Tildrakizumab for Moderate-to-Severe Plaque Psoriasis: Pooled Analysis of Three Randomised Controlled Trials.

Short-term IL-23p19 inhibition by tildrakizumab improves plaque psoriasis and appears well-tolerated.

Safety and Efficacy of a Halobetasol/Tazarotene Fixed Combination in the Treatment of Moderate-to-Severe Plaque Psoriasis: Results of two Phase 3 randomized controlled trials.

Topical corticosteroids are the mainstay of psoriasis treatment; long-term safety concerns limit use. Combination with tazarotene may optimize efficacy, minimizing safety/tolerability concerns, In pat...

Medical and Biotech [MESH] Definitions

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.

A narcotic antagonist with analgesic properties. It is used for the control of moderate to severe pain.

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.

An opioid analgesic used similarly to MORPHINE in the control of moderate to severe pain. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1097)

A group of tetraterpenes, with four terpene units joined head-to-tail. Biologically active members of this class are used clinically in the treatment of severe cystic ACNE; PSORIASIS; and other disorders of keratinization.

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