Greek Study on Work Productivity and Sleep in Patients With Rheumatic Diseases Treated With Adalimumab
This study is ongoing, but not recruiting participants.
Sponsor:
AbbVie (prior sponsor, Abbott)
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
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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:
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
Hide Study Locations
Hide Study LocationsLocations
| Greece | |
| Site Reference ID/Investigator# 40849 | |
| Ag. Dimitrios, Athens, Greece, 17121 | |
| Site Reference ID/Investigator# 40728 | |
| Ag. Nikolaos, Greece, 72100 | |
| Site Reference ID/Investigator# 40726 | |
| Agia Paraskevi, Greece, 15342 | |
| Site Reference ID/Investigator# 40703 | |
| Agioi Anargyroi, Greece, 13122 | |
| Site Reference ID/Investigator# 53645 | |
| Agrinio, Greece, 30100 | |
| Site Reference ID/Investigator# 40873 | |
| Agrinio, Greece, 30100 | |
| Site Reference ID/Investigator# 40826 | |
| Aigio, Greece, 25100 | |
| Site Reference ID/Investigator# 40987 | |
| Alexandroupoli, Greece, 68100 | |
| Site Reference ID/Investigator# 40746 | |
| Argos, Greece, 29200 | |
| Site Reference ID/Investigator# 40723 | |
| Argyroupoli Athens, Greece, 16452 | |
| Site Reference ID/Investigator# 40864 | |
| Athens, Greece, 11634 | |
| Site Reference ID/Investigator# 40714 | |
| Athens, Greece, 11635 | |
| Site Reference ID/Investigator# 40724 | |
| Athens, Greece, 11364 | |
| Site Reference ID/Investigator# 40750 | |
| Athens, Greece, 11361 | |
| Site Reference ID/Investigator# 40644 | |
| Athens, Greece, 115 25 | |
| Site Reference ID/Investigator# 40889 | |
| Athens, Greece, 11521 | |
| Site Reference ID/Investigator# 46628 | |
| Athens, Greece, 11527 | |
| Site Reference ID/Investigator# 53642 | |
| Athens, Greece | |
| Site Reference ID/Investigator# 40871 | |
| Athens, Greece, 11521 | |
| Site Reference ID/Investigator# 40749 | |
| Chalandri, Greece, 15233 | |
| Site Reference ID/Investigator# 40717 | |
| Chalkida, Greece, 34100 | |
| Site Reference ID/Investigator# 40720 | |
| Crete, Greece, 74100 | |
| Site Reference ID/Investigator# 40648 | |
| Crete, Greece | |
| Site Reference ID/Investigator# 40705 | |
| Crete, Greece, 71201 | |
| Site Reference ID/Investigator# 40708 | |
| Drama, Greece, 66100 | |
| Site Reference ID/Investigator# 40646 | |
| Elefsina, Greece, 19200 | |
| Site Reference ID/Investigator# 40712 | |
| Ermoupolis Syros, Greece | |
| Site Reference ID/Investigator# 40991 | |
| Giannitsa, Greece, 58100 | |
| Site Reference ID/Investigator# 40841 | |
| Glyfada, Greece, 16561 | |
| Site Reference ID/Investigator# 53643 | |
| Herakleion, Crete, Greece, 72201 | |
| Site Reference ID/Investigator# 41015 | |
| Ioannina, Greece, 45332 | |
| Site Reference ID/Investigator# 40831 | |
| Irakleio Crete, Greece, 71201 | |
| Site Reference ID/Investigator# 40755 | |
| Kallithea, Greece, 17672 | |
| Site Reference ID/Investigator# 53644 | |
| Kallithea, Greece, 17673 | |
| Site Reference ID/Investigator# 41007 | |
| Karditsa, Greece, 43100 | |
| Site Reference ID/Investigator# 40921 | |
| Katerini, Greece | |
| Site Reference ID/Investigator# 40990 | |
| Kavala, Greece, 65302 | |
| Site Reference ID/Investigator# 40715 | |
| Kavala, Greece, 65302 | |
| Site Reference ID/Investigator# 40877 | |
| Kifisia, Greece, 14500 | |
| Site Reference ID/Investigator# 40865 | |
| Kifissia, Greece, 14562 | |
| Site Reference ID/Investigator# 40756 | |
| Kifissia, Greece, 14561 | |
| Site Reference ID/Investigator# 40929 | |
| Kilkis, Greece, 61100 | |
| Site Reference ID/Investigator# 41024 | |
| Komotini, Greece, 69100 | |
| Site Reference ID/Investigator# 40993 | |
| Kozani, Greece, 50100 | |
| Site Reference ID/Investigator# 40718 | |
| Lamia, Greece, 35100 | |
| Site Reference ID/Investigator# 40721 | |
| Larisa, Greece, 41223 | |
| Site Reference ID/Investigator# 40894 | |
| Larissa, Greece, 41100 | |
| Site Reference ID/Investigator# 41003 | |
| Larissa, Greece, 41222 | |
| Site Reference ID/Investigator# 41002 | |
| Larissa, Greece, 41222 | |
| Site Reference ID/Investigator# 40733 | |
| Livadeia, Greece, 32100 | |
| Site Reference ID/Investigator# 40836 | |
| Mytilini, Greece, 81100 | |
| Site Reference ID/Investigator# 40740 | |
| Nea Smyrni, Greece, 17121 | |
| Site Reference ID/Investigator# 40652 | |
| Nikea, Greece, 18454 | |
| Site Reference ID/Investigator# 40729 | |
| Patras, Greece, 26221 | |
| Site Reference ID/Investigator# 40853 | |
| Pefki, Greece, 15121 | |
| Site Reference ID/Investigator# 40829 | |
| Peristeri, Greece, 12134 | |
| Site Reference ID/Investigator# 40722 | |
| Rhodes, Greece, 85100 | |
| Site Reference ID/Investigator# 40649 | |
| Thessaloniki, Greece, 54639 | |
| Site Reference ID/Investigator# 40713 | |
| Thessaloniki, Greece, 54623 | |
| Site Reference ID/Investigator# 40994 | |
| Thessaloniki, Greece, 54624 | |
| Site Reference ID/Investigator# 40650 | |
| Thessaloniki, Greece, 54622 | |
| Site Reference ID/Investigator# 40884 | |
| Thessaloniki, Greece, 570 10 | |
| Site Reference ID/Investigator# 40986 | |
| Thessaloniki, Greece, 54621 | |
| Site Reference ID/Investigator# 41000 | |
| Thessaloniki, Greece, 54642 | |
| Site Reference ID/Investigator# 40880 | |
| Thessaloniki, Greece, 54636 | |
| Site Reference ID/Investigator# 41028 | |
| Thessaloniki, Greece, 546 23 | |
| Site Reference ID/Investigator# 41029 | |
| Thessaloniki, Greece, 54631 | |
| Site Reference ID/Investigator# 41030 | |
| Thessaloniki, Greece, 54643 | |
| Site Reference ID/Investigator# 41031 | |
| Thessaloniki, Greece, 54623 | |
| Site Reference ID/Investigator# 41035 | |
| Thessaloniki, Greece, 54622 | |
| Site Reference ID/Investigator# 41037 | |
| Thessaloniki, Greece, 54622 | |
| Site Reference ID/Investigator# 46627 | |
| Thessaloniki, Greece | |
| Site Reference ID/Investigator# 40716 | |
| Thessaloniki, Greece, 54622 | |
| Site Reference ID/Investigator# 41033 | |
| Thessaloniki, Greece, 54631 | |
| Site Reference ID/Investigator# 41023 | |
| Triandria Thessaloniki, Greece, 55337 | |
| Site Reference ID/Investigator# 41010 | |
| Trikala, Greece, 42100 | |
| Site Reference ID/Investigator# 40850 | |
| Tripoli, Greece, 22100 | |
| Site Reference ID/Investigator# 40707 | |
| Veria, Greece | |
| Site Reference ID/Investigator# 40709 | |
| Volos, Greece | |
| Site Reference ID/Investigator# 40653 | |
| Xanthi, Greece, 67100 | |
| Site Reference ID/Investigator# 40731 | |
| Zakynthos, Greece, 29100 | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Chair: | Thanasis Floros, MD | AbbVie Pharmaceuticals S.A. |
More Information
Additional Information:
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 21, 2013