Advertisement

Topics

Safety and Effectiveness and Effect on Quality of Life and Work Productivity of Humira in Patients With Psoriatic Arthritis in Clinical Routine

2014-08-27 03:15:31 | BioPortfolio

Summary

Safety and effectiveness, quality of life and work productivity of Humira in patients with psoriatic arthritis in clinical routine.

Description

The primary objective of the Non-Interventional Study is to explore the therapeutic success, measured by improvements in the following target variables (with regard to the respective baseline value):

- The number of missed working days

- The self-assessed workability

- The severity of clinical symptoms (number of tender and swollen joints, C-reactive Protein and erythrocyte sedimentation rate respectively; total score Disease Activity Score 28, Psoriasis Area and Severity Index)

- The severity of functional impairment (Health Assessment Questionnaire)

- The health-related quality of life .

All of the patient and disease characteristics which are documented at baseline will be evaluated for their additional impact on the target variables (therapeutic success). Particularly the impact of previous biologic therapies on clinical target variables will be evaluated.

The secondary objective is to document the therapeutic success by the following variables:

- The number of physician visit

- The number and duration of hospitalization

- The number of days of impairment in non-occupational activities

- Pain, exhaustion/fatigue

- The reduction of number and dose of concomitant medication

- Patient's assessment of adalimumab therapy compared to previous therapies.

Target parameters for safety evaluation of adalimumab are:

- The evaluation of safety and tolerability by the documentation and analysis of serious adverse events (SAEs) and adverse events (AEs)

- Evaluation of safety and tolerability for subgroups of patients with common frequent concomitant diseases, especially diabetes type II, cardiovascular, liver, and renal insufficiencies, and related concomitant medications.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Conditions

Psoriatic Arthritis

Intervention

adalimumab (Humira)

Status

Not yet recruiting

Source

Abbott

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:31-0400

Clinical Trials [1386 Associated Clinical Trials listed on BioPortfolio]

Belgian Registry of HUMIRA (Adalimumab) in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

A five year, post-marketing observational study to follow-up patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who are treated with HUMIRA (adalimumab)

Efficacy and Safety of Humira in Patients With Psoriatic Arthritis in Normal Medical Practice

This study is a documentation of effectiveness and safety of Humira in patients with psoriatic arthritis.

A 24 Week Open Label Study of the Utility of Adalimumab in Active Axial Forms of Psoriatic Arthritis

Based on published data and according to the approved product label for ankylosing spondylitis and psoriatic arthritis, it can be expected that adalimumab 40 mg every 14 days should be eff...

EValuation of HumIRA® in Patients With Active Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis in EASTern European Countries

This is a non-interventional, post-marketing, observational study (PMOS) in which HUMIRA® (adalimumab) is prescribed in the usual manner in accordance with the terms of the local marketin...

Humira in Rheumatoid Arthritis - Do Bone Erosions Heal?

Studies on tumor necrosis factor alpha antagonist (anti-TNF) therapy in rheumatoid arthritis (RA) patients have found that erosive damage may "heal" in some RA patients treated with anti-T...

PubMed Articles [1143 Associated PubMed Articles listed on BioPortfolio]

Secukinumab for psoriatic arthritis: comparative effectiveness versus licensed biologics/apremilast: a network meta-analysis.

A network meta-analysis using randomized controlled trial data compared psoriatic arthritis (PsA) outcomes (American College of Rheumatology [ACR], Psoriasis Area Severity Index [PASI] and Psoriatic A...

Identification of a Single Nucleotide Polymorphism in NFKBIA with Different Effects on Psoriatic Arthritis and Cutaneous Psoriasis in China.

Genome-wide association studies have recently identified a number of non-major histocompatibility complex regions associated with psoriatic arthritis. However, data on Chinese patients with psoriatic ...

Differential efficacy of biologic treatments targeting the TNF-α/IL-23/IL-17 axis in psoriasis and psoriatic arthritis.

Psoriasis and psoriatic arthritis cause significant physical and psychological burdens for afflicted individuals. An accelerated TNF-α/IL-23/IL-17 axis is their major pathomechanism; therefore, anti-...

The effect of Adalimumab on the vasculature in psoriatic skin lesions.

Vascular proliferation is considered an important feature in psoriasis. Early psoriatic changes are characterized by vascular network expansion; healing of the lesions ultimately results in a decreasi...

Similar Pharmacokinetics of the Adalimumab (Humira) Biosimilar BI 695501 Whether Administered via Subcutaneous Autoinjector or Prefilled Syringe (VOLTAIRE-AI and VOLTAIRE-TAI): Phase 1, Randomized, Open-Label, Parallel-Group Trials.

BI 695501 has shown similar efficacy, safety, and immunogenicity to the adalimumab reference product, Humira. We present two phase 1 studies comparing the pharmacokinetics, safety, and immunogenicity ...

Medical and Biotech [MESH] Definitions

A humanized monoclonal antibody that binds specifically to TNF-ALPHA and blocks its interaction with endogenous TNF RECEPTORS to modulate INFLAMMATION. It is used in the treatment of RHEUMATOID ARTHRITIS; PSORIATIC ARTHRITIS; CROHN'S DISEASE and ULCERATIVE COLITIS.

A chimeric monoclonal antibody to TNF ALPHA that is used in the treatment of RHEUMATOID ARTHRITIS; ANKYLOSING SPONDYLITIS; PSORIATIC ARTHRITIS and CROHN'S DISEASE.

A type of inflammatory arthritis associated with PSORIASIS, often involving the axial joints and the peripheral terminal interphalangeal joints. It is characterized by the presence of HLA-B27-associated SPONDYLARTHROPATHY, and the absence of rheumatoid factor.

A recombinant version of soluble human TNF receptor that binds specifically to TUMOR NECROSIS FACTOR and inhibits its binding with endogenous TNF receptors. It prevents the inflammatory effect of TNF and is used to treat RHEUMATOID ARTHRITIS; PSORIATIC ARTHRITIS and ANKYLOSING SPONDYLITIS.

A polyethylene-glycolated Fab' fragment of TUMOR NECROSIS FACTOR antibody that binds specifically to TNF-ALPHA and neutralises it in a dose-dependent manner. It also inhibits the production of lipopolysaccharide-induced TNF-ALPHA and IL-1 BETA and is used to treat RHEUMATOID ARTHRITIS and PSORIATIC ARTHRITIS.

More From BioPortfolio on "Safety and Effectiveness and Effect on Quality of Life and Work Productivity of Humira in Patients With Psoriatic Arthritis in Clinical Routine"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Gout
According to the National Arthritis Data Workgroup, an estimated 6 million people in the United States report having experienced gout at some point in their lives. In fact, gout is the most common form of inflammatory arthritis in men over the age of 40....

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...


Searches Linking to this Trial