Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab

NCT ID: NCT01273519

Last Updated: 2014-03-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 155 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-01-31

Brief Summary

The purpose of this study is to assess whether or not adalimumab (Humira®) can influence pain medication in participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) with or without comorbidities, which do not constitute a contraindication for adalimumab as stated in the released summary of product characteristics. Therefore it shall be evaluated if pain medication which is used in these participants is changed, reduced or stopped due to adalimumab treatment.

Detailed Description

This is a non-interventional, observational study 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. The assignment of the patient to a Humira-containing regimen has to be decided in advance and has to be current practice. The prescription of Humira is clearly separated from the decision to include the participant in this study.

Conditions

Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

RA, PsA, AS

Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients aged ≥ 18 years for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis
• Patients must fulfill international and national guidelines for the use of a biological disease modifying antirheumatic drug in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (chest x-ray and interferon gamma release assay or purified protein derivative-skin test negative for tuberculosis). In addition one of the following criteria must be fulfilled:

• unsatisfactory disease modifying antirheumatic drug response defined as failure to treatment with at least two disease modifying antirheumatic drugs including Methotrexate in patients with rheumatoid arthritis or psoriatic arthritis
• unsatisfactory non steroidal antiinflammatory drug response in patients with ankylosing spondylitis or unsatisfactory response to prior biological disease modifying antirheumatic drugs in patients with rheumatoid arthritis or psoriatic arthritis or ankylosing spondylitis

Exclusion Criteria

• Patients who meet contraindications as outlined in the latest version of the Humira syringe® summary of product characteristics and Humira Pen® summary of product characteristics
• Patients participating in another study program or clinical trial
• Patients who have been treated with Humira before

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Raffeiner GmbH

INDUSTRY

Sponsor Role: collaborator

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Astrid Dworan-Timler, MD

Role: STUDY_DIRECTOR

AbbVie Austria

Locations

Site Reference ID/Investigator# 52144

Bludenz, , Austria

Site Reference ID/Investigator# 44915

Fürstenfeld, , Austria

Site Reference ID/Investigator# 44910

Gloggnitz, , Austria

Site Reference ID/Investigator# 44914

Graz, , Austria

Site Reference ID/Investigator# 52143

Innsbruck, , Austria

Site Reference ID/Investigator# 44916

Klagenfurt, , Austria

Site Reference ID/Investigator# 44911

Linz, , Austria

Site Reference ID/Investigator# 44912

Linz, , Austria

Site Reference ID/Investigator# 44913

Linz, , Austria

Site Reference ID/Investigator# 44906

Neudorf, , Austria

Site Reference ID/Investigator# 44909

Sankt Pölten, , Austria

Site Reference ID/Investigator# 52145

Spitz, , Austria

Site Reference ID/Investigator# 44908

Stockerau, , Austria

Site Reference ID/Investigator# 67062

Vienna, , Austria

Site Reference ID/Investigator# 57304

Vöcklabruck, , Austria

Countries

Austria

Related Links

http://rxabbvie.com

Related Info

Other Identifiers

P12-585

Identifier Type: -

Identifier Source: org_study_id