Clinical trial NCT01083693: 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
Official title: An Open Label Multicenter Post Marketing Observational Study for the Evaluation of Quality of Life Outcomes and Tolerability of HUMIRA in Routine Clinical Use in Patients With RA PsA AS After Unsustainable Response to Disease Modifying Antirheumatic Drugs and or Biologicals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis
Keywords: Monoclonals
Antibodies
Ankylosing Spondylitis
Antirheumatic Agents
Quality of Life
Adalimumab
rheumatoid arthritis
psoriatic arthritis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Group Data Management Biostatistics
First posted: 2010-03-10
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic and medical practice specialized in rheumatology

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.


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.

Primary outcomes:
measure: RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI
timeFrame: Baseline, months 3,6,9,12
measure: SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
timeFrame: Baseline, months 3,6,9,12
measure: EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression
timeFrame: Baseline, months 3,6,9,12
Secondary outcomes:
measure: DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale
timeFrame: Baseline,months 3,6,9,12
measure: Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness
timeFrame: Baseline, months 3,6,9,12
measure: Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only
timeFrame: Baseline, months 3,6,9,12
measure: Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only
timeFrame: Baseline, months 3,6,9,12
measure: Erythrocyte Sedimentation Rate
timeFrame: Baseline, months 3,6,9,12
measure: C-Reactive Protein
timeFrame: Baseline, months 3,6,9,12
Other outcomes:
Locations:
city: Amstetten
country: Austria
facility: Site Reference ID/Investigator # 32372
city: Bludenz
country: Austria
facility: Site Reference ID/Investigator # 32368
city: Gloggnitz
country: Austria
facility: Site Reference ID/Investigator # 32367
city: Graz
country: Austria
facility: Site Ref # / Investigator 37123
city: Innsbruck
country: Austria
facility: Site Ref # / Investigator 37125
city: Klagenfurt
country: Austria
facility: Site Reference ID/Investigator # 32375
city: Linz
country: Austria
facility: Site Reference ID/Investigator # 32365
city: Linz
country: Austria
facility: Site Reference ID/Investigator # 32369
city: Linz
country: Austria
facility: Site Reference ID/Investigator # 32371
city: Linz
country: Austria
facility: Site Reference ID/Investigator # 32376
city: Neudorf
country: Austria
facility: Site Reference ID/Investigator # 32373
city: Salzburg
country: Austria
facility: Site Reference ID/Investigator # 32364
city: Vienna
country: Austria
facility: Site Reference ID/Investigator # 18782
city: Vienna
country: Austria
facility: Site Reference ID/Investigator # 32363
city: Vienna
country: Austria
facility: Site Reference ID/Investigator # 32377
city: Vienna
country: Austria
facility: Site Reference ID/Investigator # 32378
city: Vienna
country: Austria
facility: Site Reference ID/Investigator # 32366
city: Voecklabruck
country: Austria
facility: Site Reference ID/Investigator # 32374
city: Weiz
country: Austria
facility: Site Reference ID/Investigator # 32370
city: Wels
country: Austria
facility: Site Ref # / Investigator 37124
Study officials:
affiliation: Abbott AUSTRIA
name: Astrid Dworan-Timler, MD
role: STUDY_DIRECTOR
References: