Advertisement

Topics

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

2014-07-23 21:09:57 | BioPortfolio

Summary

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 marketing authorization with regards to dose, population and indication.

No data currently exists to characterize patient populations being prescribed HUMIRA® in Eastern Europe. Further, it is important to establish the clinical outcome and tolerability of HUMIRA® in Eastern European patients, as well as their compliance with HUMIRA® treatment, in particular the acceptability of self-injection, which may influence all of the above in routine clinical practice.

Description

The primary objective of this post-marketing observational study (PMOS) is to evaluate the clinical outcome of HUMIRA® in routine clinical use in rheumatologic patients in different Eastern European countries.

The secondary objectives of this PMOS are to evaluate in rheumatologic patients being routinely treated with Humira in Eastern Europe:

- Tolerability of treatment with HUMIRA®

- Duration of treatment with HUMIRA ®

- Change in Quality of Life (HAQ-DI)

- Patient acceptability of self-injection and compliance with therapy

- Patient characteristics (demographic, social, disease type, severity and duration)

- The routine rheumatologic practices (previous and current disease specific treatment) Each patient will be observed during his/her HUMIRA® treatment for a period of max. 13 months.

If the physician decides to permanently discontinue HUMIRA® before the end of the planned observational period of 13 months, the reason for discontinuation and the new treatment regimen prescribed, if applicable, will be documented. The next routine follow-up visit will be the termination visit for this patient in the PMOS.

The tuberculosis (TB) screening period per patient will be 1-4 weeks and, if applicable, the TB prophylactic treatment period before HUMIRA® administration will be 1 month in accordance with local Guidelines.

Study Conduct This PMOS will be conducted in a prospective, single-arm, multicountry, multicenter format.

As this study is observational in nature, its follow-up is not interventional and is left to the judgment of each physician within the 14-17 months period (including TB screening and prophylaxis, if indicated), which defines the survey for each patient.

For indicative purposes, follow-up of patients should enable approximately 7 patient visits during this period. These visits will take place at average intervals of 3 months, apart from the first visit following TB screening, the first visit following introduction of Humira and final visits required because of intercurrent events. If treatment with Humira® is discontinued, the standard practice is to review the patient after a period of 70 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.

For these reasons, the most likely visits are defined as "V1", "V2", "V3", "V4", "V5", "V6", "V7", although numbers and dates will depend only on the decision of the physician:

- V1: Screening visit (followed by TB prophylaxis, if indicated)

- V2: Baseline and introduction of HUMIRA® therapy

- V3: 1 month after introduction of HUMIRA® therapy

- V4: 3 months after previous visit

- V5: 3 months after previous visit

- V6: 3 months after previous visit

- V7: 3 months after previous visit Failure to meet these suggested dates will not constitute a breach of the protocol.

Study Design

Time Perspective: Prospective

Conditions

Rheumatoid Arthritis

Location

Site Reference ID/Investigator# 32631
Budapest
Hungary
1027

Status

Recruiting

Source

Abbott

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:57-0400

Clinical Trials [1187 Associated Clinical Trials listed on BioPortfolio]

Safety Study of Abatacept to Treat Rheumatoid Arthritis

The purpose of this study is to compare the incidence rates of infection, malignancy and death among patients with rheumatoid arthritis who are treated with abatacept and those who are tre...

Activity Limitations in Rheumatoid Arthritis

Objective: To evaluate what factors contribute to activity limitations in subjects with rheumatoid arthritis considering the International Classification of Functioning, Disability and Hea...

Rosuvastatin in Rheumatoid Arthritis (RORA)

Patients with rheumatoid arthritis are at increased risk of having cardiovascular deaths. Our study is aimed at looking at the effects of proven cholesterol lowering treatment drug called ...

A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients

This study will look at whether this new drug is effective in the treatment of rheumatoid arthritis, and at whether it is safe and well-tolerated by patients with the disease.

A Multiple Dose Study to Evaluate Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis

The purpose of this study is to determine if AMG 108 in combination with methotrexate is safe and effective in the treatment of rheumatoid arthritis.

PubMed Articles [1191 Associated PubMed Articles listed on BioPortfolio]

Validity of the Rheumatoid Arthritis Impact of Disease (RAID) score and definition of cut-off points for disease activity states in a population-based European cohort of patients with rheumatoid arthritis.

To assess the validity of the Rheumatoid Arthritis Impact of Disease (RAID) for measuring disease activity of rheumatoid arthritis (RA), and to determine cut-off values for defining the disease activi...

Triple Therapy Versus Biologic Therapy for Active Rheumatoid Arthritis: A Cost-Effectiveness Analysis.

The RACAT (Rheumatoid Arthritis Comparison of Active Therapies) trial found triple therapy to be noninferior to etanercept-methotrexate in patients with active rheumatoid arthritis (RA).

Genetic variation of the alpha-1-antitrypsin gene is associated with increased autoantibody production in rheumatoid arthritis.

To examine the prevalence of alpha-1 antitrypsin (AAT) deficiency (AATD) in rheumatoid arthritis (RA), and to determine if AATD is associated with higher levels of rheumatoid factor (RF), antinuclear ...

Trends of hospitalization for serious infections in patients with rheumatoid arthritis in the US between 1993 and 2013.

Epidemiology of hospitalizations with infection among patients with rheumatoid arthritis (RA) is unknown despite an increase in RA treatments that confer infection risk.

The projected burden of osteoarthritis and rheumatoid arthritis in Australia: A population-level analysis.

To forecast the prevalence and direct healthcare costs of osteoarthritis (OA) and rheumatoid arthritis (RA) in Australia to the year 2030.

Medical and Biotech [MESH] Definitions

Arthritis in children, with onset before 16 years of age. The terms juvenile rheumatoid arthritis (JRA) and juvenile idiopathic arthritis (JIA) refer to classification systems for chronic arthritis in children. Only one subtype of juvenile arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.

Rheumatoid arthritis of children occurring in three major subtypes defined by the symptoms present during the first six months following onset: systemic-onset (Still's Disease, Juvenile-Onset), polyarticular-onset, and pauciarticular-onset. Adult-onset cases of Still's disease (STILL'S DISEASE, ADULT-ONSET) are also known. Only one subtype of juvenile rheumatoid arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.

A variable mixture of the mono- and disodium salts of gold thiomalic acid used mainly for its anti-inflammatory action in the treatment of rheumatoid arthritis. It is most effective in active progressive rheumatoid arthritis and of little or no value in the presence of extensive deformities or in the treatment of other forms of arthritis.

Systemic-onset rheumatoid arthritis in adults. It differs from classical rheumatoid arthritis in that it is more often marked by acute febrile onset, and generalized lymphadenopathy and hepatosplenomegaly are more prominent.

Antibodies found in adult RHEUMATOID ARTHRITIS patients that are directed against GAMMA-CHAIN IMMUNOGLOBULINS.

More From BioPortfolio on "EValuation of HumIRA® in Patients With Active Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis in EASTern European Countries"

Quick Search
Advertisement
 

Searches Linking to this Trial