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Greek Study on Work Productivity and Sleep in Patients With Rheumatic Diseases Treated With Adalimumab

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01282372
First received: January 21, 2011
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  Purpose

Primary objective

• To evaluate the mean change from baseline of activity impairment as measured by the Work Productivity and Activity Impairment - General Health Problem Questionnaire instrument in patients with rheumatic diseases (Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis) treated with adalimumab, over a period of two years, as prescribed by the rheumatologist in a normal clinical setting and in accordance with the terms of the Greek Summary Product Characteristics

Secondary objectives

To assess the effect of adalimumab at 3, 6, 12, 18 and 24 months of treatment as:

  • Evolution of all components of Work Productivity and Activity Impairment - General Health Problem Questionnaire (absenteeism, presenteeism, percentage of overall work and activity impairment due to the disease) in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis patients
  • Change of Disease Activity Score for 28 joints and Health Assessment Questionaire Scoring in Rheumatoid Arthritis patients
  • Alteration of Bath Ankylosing Spondylitis Disease Activity Index scoring in Ankylosing Spondylitis patients
  • Alteration of Psoriatic Arthritis Response Criteria scoring in Psoriatic Arthritis patients
  • Effect on sleep disturbances as measured by Medical Outcomes Study Sleep Scale instrument in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis patients
  • Correlation of mean change of Disease Activity Score for 28 joints and Health Assessment Questionnaire, Bath Ankylosing Spondylitis Disease Activity Index and Psoriatic Arthritis Response Criteria from baseline until 24 months of treatment with number of missed workdays, degree of work performance and sleep disturbances in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis patients

Condition
Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A 2-year Health Related Quality of Life Observational Study Evaluating the Effect of Treatment With Adalimumab on Work Productivity and Sleep in Patients With Rheumatic Diseases in Greece

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Mean change from baseline of activity impairment as measured by the Work Productivity and Activity Impairment - General Health Problem Quest. instrument [ Time Frame: Baseline up to 24 months ] [ Designated as safety issue: No ]
    In patients with rheumatic diseases (Rheumatoid Arthritis,Ankylosing Spondylitis,Psoriatic Arthritis)


Secondary Outcome Measures:
  • Evolution of all components of Work Productivity and Activity Impairment - General Health Problem Questionnaire (absenteeism, presenteeism, percentage of overall work and activity impairment due to the disease) [ Time Frame: Baseline up to 24 months ] [ Designated as safety issue: No ]
    In Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis patients

  • Mean change of Disease Activity Score for 28 joints and Health Assessment Questionnaire Scoring [ Time Frame: Baseline up to 24 months ] [ Designated as safety issue: No ]
    In Rheumatoid Arthritis patients

  • Mean alteration of Bath Ankylosing Spondylitis Disease Activity Index scoring [ Time Frame: Baseline up to 24 months ] [ Designated as safety issue: No ]
    In Ankylosing Spondylitis patients

  • Mean alteration of Psoriatic Arthritis Response Criteria scoring [ Time Frame: Baseline up to 24 months ] [ Designated as safety issue: No ]
    In Psoriatic Arthritis patients


Estimated Enrollment: 500
Study Start Date: March 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with rheumatic diseases
All eligible patients with rheumatic diseases treated with Adalimumab

Detailed Description:

Work Productivity is improved in patients with rheumatic diseases after treatment with Tumor Necrosis Factor antagonists, especially adalimumab. There are no data for Work Productivity in Psoriatic Arthritis and limited data exist for Sleep disturbance in patients treated with adalimumab. Since there are no data for Work productivity and Sleep disturbance in Greek patients with rheumatic diseases (Rheumatoid Arthritis, Ankylosing spondylitis, Psoriatic arthritis) the effect of treatment with adalimumab will be assessed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients treated with Adalimumab according to routine medical practice from hospital and private physicians.

Criteria

Inclusion Criteria:

  • Patients with moderate or severe active rheumatic disease, who have been prescribed Humira under normal clinical practice and according to the approved local Summary Product Characteristics
  • Patients must be willing to consent to data being collected and provided to AbbVie

Exclusion Criteria:

  • Contraindications according to the Summary Product Characteristics
  • Patients should not participate in other observational AbbVie study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282372

  Show 81 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Chair: Thanasis Floros, MD AbbVie Pharmaceuticals S.A.
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01282372     History of Changes
Other Study ID Numbers: P12-179
Study First Received: January 21, 2011
Last Updated: April 16, 2013
Health Authority: Greece: National Organization of Medicines

Keywords provided by AbbVie:
Ankylosing spondylitis
Sleep
Psoriatic arthritis
Work Productivity
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Arthritis, Rheumatoid
Rheumatic Diseases
Spondylitis
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spinal Diseases
Bone Diseases
Psoriasis
 Skin Diseases, Papulosquamous
Skin Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infection
Ankylosis
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 16, 2013