Quality of Life Outcomes of HUMIRA in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) After Unsustainable Response to Biologicals and Disease Modifying Antirheumatic Drugs

NCT ID: NCT01083693

Last Updated: 2011-08-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 162 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-06-30

Brief Summary

The aim of this post-marketing observational study is to obtain further data on the evaluation of quality of life outcomes of HUMIRA® in routine clinical use in patients with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Ankylosing Spondylitis (AS) after unsustainable clinical response to disease modifying antirheumatic drugs (DMARD) and or biological disease modifying antirheumatic drugs (BDMARD). Treatment strategies in moderate to severe rheumatoid arthritis, psoriatic arthritis and in severe active ankylosing spondylitis commonly consist of introducing biologics after conventional disease modifying antirheumatic drugs or non steroidal antiinflammatory drugs fail. Although biologic disease modifying antirheumatic drugs are generally well-tolerated, intolerances may develop or efficacy may diminish, at which time another biologic disease modifying antirheumatic drug might be considered. This study shall evaluate the quality of life outcomes of HUMIRA®, given after conventional disease modifying antirheumatic drugs and or non antiinflammatory drug failures and or after biological disease modifying antirheumatic drug failures . Failure in this context means primary or secondary loss of efficacy or intolerance to the initial agent.

Conditions

Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis

Study Design

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

Study Groups

Rheumatoid, Psoriatic Arthritis, Ankylosing Spondylitis

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, patients with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients age greater than or equal to 18
• Patients must fulfill international and national guidelines for use of a BDMARD in RA, PsA and AS (Chest X-ray and purified protein derivative (PPD) skin test negative for tuberculosis).

In addition one of the following criteria must be fulfilled:

• unsatisfactory DMARD response defined as failure to treatment with at least two DMARDs including Methotrexate in patients with RA or PsA
• unsatisfactory NSAID response in patients with AS or
• unsatisfactory response to prior BDMARDs (in this case patients must have received BDMARDs at least 12 weeks before visit 1) in patients with RA or PsA or AS.

Exclusion Criteria

• Patients who meet contraindications as outlined in the latest version of the Humira syringe® Summary of Product Characteristics (SmPC) and Humira Pen® SmPC
• Patients participating in another study or clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Group Data Management Biostatistics

UNKNOWN

Sponsor Role: collaborator

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Abbott AUSTRIA

Principal Investigators

Astrid Dworan-Timler, MD

Role: STUDY_DIRECTOR

Abbott AUSTRIA

Locations

Site Reference ID/Investigator # 32372

Amstetten, , Austria

Site Reference ID/Investigator # 32368

Bludenz, , Austria

Site Reference ID/Investigator # 32367

Gloggnitz, , Austria

Site Ref # / Investigator 37123

Graz, , Austria

Site Ref # / Investigator 37125

Innsbruck, , Austria

Site Reference ID/Investigator # 32375

Klagenfurt, , Austria

Site Reference ID/Investigator # 32365

Linz, , Austria

Site Reference ID/Investigator # 32369

Linz, , Austria

Site Reference ID/Investigator # 32371

Linz, , Austria

Site Reference ID/Investigator # 32376

Linz, , Austria

Site Reference ID/Investigator # 32373

Neudorf, , Austria

Site Reference ID/Investigator # 32364

Salzburg, , Austria

Site Reference ID/Investigator # 18782

Vienna, , Austria

Site Reference ID/Investigator # 32363

Vienna, , Austria

Site Reference ID/Investigator # 32377

Vienna, , Austria

Site Reference ID/Investigator # 32378

Vienna, , Austria

Site Reference ID/Investigator # 32366

Vienna, , Austria

Site Reference ID/Investigator # 32374

Vöcklabruck, , Austria

Site Reference ID/Investigator # 32370

Weiz, , Austria

Site Ref # / Investigator 37124

Wels, , Austria

Countries

Austria

Other Identifiers

P10-726

Identifier Type: -

Identifier Source: org_study_id