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

NCT01083693 | Completed Results

• 1 other identifier: P10-726
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 20

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

Keywords

Monoclonals; Antibodies; Ankylosing Spondylitis; Antirheumatic Agents; Quality of Life; Adalimumab; rheumatoid arthritis; psoriatic arthritis

Outcome Measures

Primary Outcomes (3)

• RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI

  The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures a patient's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip, activities. Each question is evaluated according to the degree of severity on a scale ranging from 0 (without any difficulty) to 3 (unable to do).

  Baseline, months 3,6,9,12

• 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

  Medical Outcomes Study Short Form 36 (MOS SF-36) is generic assessment of health status that consists of 36 questions within 8 domains including Physical Functioning (PF), Role Functioning - Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Functioning - Emotional (RE), Mental Health (MH) and Reported Health Transition (HT). Results from each domain are summarized and transformed into a scale ranging from 0 (worst) to 100 (best) with the exception of HT. The score range for HT is 0 (worst) to 5 (best).

  Baseline, months 3,6,9,12

• 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

  European Quality of Life 5 Dimensions (EQ-5D) is a self-reported health outcome which measures mobility, self care, usual activities, pain discomfort, anxiety depression. An overall score is derived that measures from -0.59 (worst) to +1 (best). In addition, health state is measured on the thermometer scale (score 0 to 100) with higher scores representing better health status.

  Baseline, months 3,6,9,12

Secondary Outcomes (6)

• 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

  Baseline,months 3,6,9,12

• 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

  Baseline, months 3,6,9,12

• Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only

  Baseline, months 3,6,9,12

• Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only

  Baseline, months 3,6,9,12

• Erythrocyte Sedimentation Rate

  Baseline, months 3,6,9,12

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic and medical practice specialized in rheumatology

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead
• Group Data Management Biostatistics: collaborator

Study Sites (20)

Site Reference ID/Investigator # 32372

Amstetten, A-3300, Austria

Location

Site Reference ID/Investigator # 32368

Bludenz, A-6700, Austria

Location

Site Reference ID/Investigator # 32367

Gloggnitz, A-2640, Austria

Location

Site Ref # / Investigator 37123

Graz, A-8020, Austria

Location

Site Ref # / Investigator 37125

Innsbruck, A-6020, Austria

Location

Site Reference ID/Investigator # 32375

Klagenfurt, A-9020, Austria

Location

Site Reference ID/Investigator # 32365

Linz, A-4020, Austria

Location

Site Reference ID/Investigator # 32369

Linz, A-4020, Austria

Location

Site Reference ID/Investigator # 32371

Linz, A-4020, Austria

Location

Site Reference ID/Investigator # 32376

Linz, A-4020, Austria

Location

Site Reference ID/Investigator # 32373

Neudorf, A-2351, Austria

Location

Site Reference ID/Investigator # 32364

Salzburg, A-5020, Austria

Location

Site Reference ID/Investigator # 18782

Vienna, A-1030, Austria

Location

Site Reference ID/Investigator # 32363

Vienna, A-1030, Austria

Location

Site Reference ID/Investigator # 32377

Vienna, A-1100, Austria

Location

Site Reference ID/Investigator # 32378

Vienna, A-1100, Austria

Location

Site Reference ID/Investigator # 32366

Vienna, A-1140, Austria

Location

Site Reference ID/Investigator # 32374

Vöcklabruck, A-4840, Austria

Location

Site Reference ID/Investigator # 32370

Weiz, A-8160, Austria

Location

Site Ref # / Investigator 37124

Wels, A-4600, Austria

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

1-800-633-9110

Study Officials

• Astrid Dworan-Timler, MD

  Abbott AUSTRIA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 28, 2010
• First Posted: March 10, 2010
• Study Start: September 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 11, 2011
• Results First Posted: July 26, 2011

Record last verified: 2011-08

Locations

AU (20)