N/A
N=161
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
Rheumatoid Arthritis · Ankylosing Spondylitis · Psoriatic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01083693 ↗Enrolled (actual)
161
Serious AEs
5.0%
Results posted
Jul 2011
Primary outcome: Primary: RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI — 1.2; 0.9; 1.1; 0.9 Units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI |
1.2; 0.9; 1.1; 0.9; 0.4; 0.8 | — |
| PRIMARY 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 |
51.4; 58.1; 53.3; 53.1; 67.4; 74.3 | — |
| PRIMARY 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 |
0.5; 0.5; 0.4; 0.5; 0.7; 0.8 | — |
| SECONDARY 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 |
5.4; 4.9; 5.3; 3.8; 3.0; 3.7 | — |
| SECONDARY 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 |
6.0; 2.8; 2.0; 2.4; 2.5; 4.6 | — |
| SECONDARY Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only |
55.1; 52.0; 54.4; 28.8; 29.0; 28.9 | — |
| SECONDARY Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only |
51.4; 46.8; 50.4; 29.9; 25.3; 28.9 | — |
| SECONDARY Erythrocyte Sedimentation Rate |
35.8; 31.7; 25.2; 32.4; 25.3; 16.0 | — |
| SECONDARY C-Reactive Protein |
1.9; 1.1; 1.4; 1.7; 1.2; 0.7 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01083693). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.