Clinical trial NCT01273519: Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab
Official title: Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis
Keywords: Ankylosing
Rheumatoid
Antibodies
Arthritis
Pain
Antirheumatic Agents
Psoriatic
Spondylitis
Monoclonals
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Raffeiner GmbH
First posted: 2011-01-10
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
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 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.

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

Primary outcomes:
measure: Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Physician Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12
timeFrame: Baseline, Month 12
measure: Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12
timeFrame: Baseline, Month 12
measure: Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12
timeFrame: Baseline, Month 12
measure: Participant Assessment of the Pattern of Pain Progression (Sudden/Creeping) in the Past 3 Months at Baseline and Month 12
timeFrame: Baseline, Month 12
measure: Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12
timeFrame: Baseline, Month 12
measure: Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Scores at Baseline, and Months 3, 6, 9, and 12
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for Participants With Ankylosing Spondylitis (AS) at Baseline, and Months 3, 6, 9, and 12
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12
timeFrame: Baseline, Months 3, 6, 9, 12
Other outcomes:
Locations:
city: Bludenz
country: Austria
facility: Site Reference ID/Investigator# 52144
city: Fuerstenfeld
country: Austria
facility: Site Reference ID/Investigator# 44915
city: Gloggnitz
country: Austria
facility: Site Reference ID/Investigator# 44910
city: Graz
country: Austria
facility: Site Reference ID/Investigator# 44914
city: Innsbruck
country: Austria
facility: Site Reference ID/Investigator# 52143
city: Klagenfurt
country: Austria
facility: Site Reference ID/Investigator# 44916
city: Linz
country: Austria
facility: Site Reference ID/Investigator# 44911
city: Linz
country: Austria
facility: Site Reference ID/Investigator# 44912
city: Linz
country: Austria
facility: Site Reference ID/Investigator# 44913
city: Neudorf
country: Austria
facility: Site Reference ID/Investigator# 44906
city: Spitz
country: Austria
facility: Site Reference ID/Investigator# 52145
city: St. Poelten
country: Austria
facility: Site Reference ID/Investigator# 44909
city: Stockerau
country: Austria
facility: Site Reference ID/Investigator# 44908
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 67062
city: Voecklabruck
country: Austria
facility: Site Reference ID/Investigator# 57304
Study officials:
affiliation: AbbVie Austria
name: Astrid Dworan-Timler, MD
role: STUDY_DIRECTOR
References: