Canadian Humira Post Marketing Observational Epidemiological Study Assessing Effectiveness in Psoriatic Arthritis
- Conditions
- Psoriatic Arthritis
- Registration Number
- NCT01559038
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- Brief Summary
The current study will assess the real - life effectiveness of adalimumab in the management of articular and dermatological manifestations of moderate to severe Psoriatic Arthritis (PsA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 483
- Adult >= 18 years old
- Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel
- Active Psoriatic Arthritis (PsA) with three (3) or more tender and swollen joints as well as active psoriatic skin lesions or confirmed history of psoriasis
- Inadequate response or non-tolerant to current disease-modifying antirheumatic drugs (DMARD) based treatment for PsA
- Currently participating in another prospective study including controlled clinical trials and observational studies
- Patient cannot or will not sign informed consent
- Stable disease with adequate tolerance and response to current treatment and no change in treatment is indicated
- Previous treatment with anti-tumor necrosis factor (anti-TNF) or other biologic agent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the Disease Activity Score - 28 (DAS-28) Every 3 months up to 6 months, then every 6 months up to 24 months The DAS - 28 is calculated using the number of swollen (SJC) and tender (TJC) joints out of 28, the erythrocyte sedimentation rate (ESR) and the patient's global assessment of disease activity using a 100 mm visual analogue scale (VAS)
- Secondary Outcome Measures
Name Time Method Duration of Morning Stiffness (min) Every 3 months up to 6 months, then every 6 months up to 24 months This is ascertained by the treating physician during the patient assessment and is measured in minutes
Dermatology Life Quality Index (DLQI) Baseline, month 6, month12, month 24 This is a self-administered questionnaire comprised of 10 items assessing a patient's skin and problems associated with skin disease. The 10 questions in the DLQI converge into six domains that measure symptoms and feelings, daily activities, leisure, work and / or school, personal relationships and satisfaction with treatment.
Health Assessment Questionnaire - Disability Index (HAQ-DI) Every 3 months up to 6 months, then every 6 months up to 24 months Self-administered questionnaire measuring the patient's functional ability during the last week.
Patient Global Assessment of Disease Activity (VAS and 5 Point Scale) Every 3 months up to 6 months, then every 6 months up to 24 months A 100 mm VAS with 0 indicating lowest disease and 100 highest disease activity and a five point Likert Scale (0 - 4) that is completed by the patient at the physician's office
Physician Global Assessment of Disease Activity (VAS and 5 Point Scale) Every 3 months up to 6 months, then every 6 months up to 24 months This is a 100 mm VAS with 0 indicating lowest disease and 100 highest disease activity a five point Likert Scale (0 - 4) that is completed by the physician during the patient examination
Trial Locations
- Locations (41)
Pont, Cranbrook, BC, CA /ID# 69120
🇨🇦Cranbrook, British Columbia, Canada
Hudson, Kamloops, Canada /ID# 69104
🇨🇦Kamloops, British Columbia, Canada
Dr. Maqbool R. Sheriff Inc. /ID# 69125
🇨🇦Nanaimo, British Columbia, Canada
Carmi Medical Clinic /ID# 69128
🇨🇦Penticton, British Columbia, Canada
Qe Ii Hsc /Id# 69129
🇨🇦Halifax, Nova Scotia, Canada
Dr. Alfonso Verdejo Inc. /ID# 69131
🇨🇦Vancouver, British Columbia, Canada
Dr. Juris Lazovskis Inc. /ID# 69111
🇨🇦Sydney, Nova Scotia, Canada
Institut de Rhum. de Montreal /ID# 69100
🇨🇦Montreal, Quebec, Canada
PSS Medical Inc. /ID# 69127
🇨🇦Montreal, Quebec, Canada
Couture, Outremont, CA /ID# 69090
🇨🇦Outremont, Quebec, Canada
Groupe de Recherche en Maladies Osseuses /ID# 69087
🇨🇦Sainte-foy, Quebec, Canada
Ctr. de Rheum de l'est du QC /ID# 69097
🇨🇦Rimouski, Quebec, Canada
Waterside Clinique /ID# 72173
🇨🇦Barrie, Ontario, Canada
Dr. Barbara T. Blumenauer Inc. /ID# 75393
🇨🇦Kamloops, British Columbia, Canada
Dr. Milton F. Baker Inc. /ID# 69085
🇨🇦Victoria, British Columbia, Canada
Brockville Medical Center /ID# 69105
🇨🇦Brockville, Ontario, Canada
Shickh, Bowmanville, Canada /ID# 90513
🇨🇦Bowmanville, Ontario, Canada
Dr. Sanjay Dixit Medicine Professional Corporation /ID# 69092
🇨🇦Burlington, Ontario, Canada
Charlton Medical Centre /ID# 69122
🇨🇦Hamilton, Ontario, Canada
Dr. Chrisotomor Kouroukis & Dr /ID# 137894
🇨🇦Dundas, Ontario, Canada
Brandusa Florica Med Prof Corp /ID# 81876
🇨🇦Mississauga, Ontario, Canada
Lynderm Research Inc. /ID# 76736
🇨🇦Markham, Ontario, Canada
Charlton Medical Centre /ID# 133073
🇨🇦Hamilton, Ontario, Canada
Dr. William G. Bensen Centre /ID# 69086
🇨🇦Hamilton, Ontario, Canada
West Mountain Medical Center /ID# 128878
🇨🇦Hamilton, Ontario, Canada
Credit Valley Rheumatology /ID# 69089
🇨🇦Mississauga, Ontario, Canada
Imtiaz MS Khan Medicine Prof /ID# 69110
🇨🇦Mississauga, Ontario, Canada
Rajwinder S. Dhillon Medicine /ID# 138672
🇨🇦Niagara Falls, Ontario, Canada
Setty, Owen Sound, CA /ID# 69123
🇨🇦Owen Sound, Ontario, Canada
Davis, Ottawa, CA /ID# 69091
🇨🇦Ottawa, Ontario, Canada
Karasik, Toronto, CA /ID# 69109
🇨🇦Toronto, Ontario, Canada
York Dermatology Clinic and Research Centre /ID# 127943
🇨🇦Richmond Hill, Ontario, Canada
Jonathan Stein Med Prof Corp /ID# 71134
🇨🇦Toronto, Ontario, Canada
Pedvis Med Prof Corp /ID# 69388
🇨🇦Toronto, Ontario, Canada
CHUS - Hopital Fleurimont /ID# 94735
🇨🇦Sherbrooke, Quebec, Canada
Ctr. de Recherche Musculo-Sque /ID# 69112
🇨🇦Trois-rivières, Quebec, Canada
Rheum Disease Ctr of Montreal /ID# 143964
🇨🇦Westmount, Quebec, Canada
Manitoba Clinic /ID# 69113
🇨🇦Winnipeg, Manitoba, Canada
Dr. J. Antonio Avina-Zubieta /ID# 71035
🇨🇦Richmond, British Columbia, Canada
Nexus Clinical Research /ID# 45622
🇨🇦St. John's, Newfoundland and Labrador, Canada
St. Clare's Mercy Hospital /ID# 69121
🇨🇦St. John's, Newfoundland and Labrador, Canada