Canadian Humira Post Marketing Observational Epidemiological Study Assessing Effectiveness in Psoriatic Arthritis (Complete-PsA)
This study is currently recruiting participants.
Verified May 2013 by AbbVie
Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborators:
CATO Research Canada
JSS Medical Research Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01559038
First received: March 19, 2012
Last updated: May 17, 2013
Last verified: May 2013
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Purpose
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).
| Condition |
|---|
|
Psoriatic Arthritis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Canadian Humira Post Marketing Observational Epidemiological Study Assessing Effectiveness in Psoriatic Arthritis (Complete‐ PsA) |
Resource links provided by NLM:
Genetics Home Reference related topics:
psoriatic arthritis
Drug Information available for:
Adalimumab
U.S. FDA Resources
Further study details as provided by AbbVie:
Primary Outcome Measures:
- Change in the Disease Activity Score - 28 (DAS-28) [ Time Frame: Every 3 months up to 6 months, then every 6 months up to 24 months ] [ Designated as safety issue: No ]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:
- Health Assessment Questionnaire - Disability Index (HAQ-DI) [ Time Frame: Every 3 months up to 6 months, then every 6 months up to 24 months ] [ Designated as safety issue: No ]Self-administered questionnaire measuring the patient's functional ability during the last week.
- Physician Global Assessment of Disease Activity (VAS and 5 Point Scale) [ Time Frame: Every 3 months up to 6 months, then every 6 months up to 24 months ] [ Designated as safety issue: No ]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
- Patient Global Assessment of Disease Activity (VAS and 5 Point Scale) [ Time Frame: Every 3 months up to 6 months, then every 6 months up to 24 months ] [ Designated as safety issue: No ]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
- Duration of Morning Stiffness (min) [ Time Frame: Every 3 months up to 6 months, then every 6 months up to 24 months ] [ Designated as safety issue: No ]This is ascertained by the treating physician during the patient assessment and is measured in minutes
- Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline, month 6, month12, month 24 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 670 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | May 2018 |
| Estimated Primary Completion Date: | May 2018 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
DMARD (disease-modifying antirheumatic drugs)
Initiated on non-biologic DMARD(disease-modifying antirheumatic drugs) or requiring switching to another non biologic DMARD (disease-modifying antirheumatic drugs) as monotherapy, or in combination with other medications
|
|
adalimumab
Responding to treatment with non-biologic DMARDs (disease-modifying antirheumatic drugs) and initiated on treatment with adalimumab as monotherapy or in combination with other medications
|
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
Offices of community rheumatologists & dermatologists
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559038
Contacts
| Contact: Annie Daudrumez | 514-832-7498 | annie.daudrumez@abbvie.com |
| Contact: Chantal Lacasse | 514-832-7728 | chantal.lacasse@abbvie.com |
Locations
| Canada | |
| Site Reference ID/Investigator# 72173 | Recruiting |
| Barrie, Canada, L4M 6L2 | |
| Principal Investigator: Site Reference ID/Investigator# 72173 | |
| Site Reference ID/Investigator# 69105 | Recruiting |
| Brockville, Canada, K2G 5J9 | |
| Principal Investigator: Site Reference ID/Investigator# 69105 | |
| Site Reference ID/Investigator# 69092 | Recruiting |
| Burlington, Canada, L7L 0B7 | |
| Principal Investigator: Site Reference ID/Investigator# 69092 | |
| Site Reference ID/Investigator# 69120 | Recruiting |
| Cranbrook, Canada, V1C 2R8 | |
| Principal Investigator: Site Reference ID/Investigator# 69120 | |
| Site Reference ID/Investigator# 69129 | Recruiting |
| Halifax, Canada, B3H 4K4 | |
| Principal Investigator: Site Reference ID/Investigator# 69129 | |
| Site Reference ID/Investigator# 69086 | Recruiting |
| Hamilton, Canada, L8N 1Y2 | |
| Principal Investigator: Site Reference ID/Investigator# 69086 | |
| Site Reference ID/Investigator# 69122 | Recruiting |
| Hamilton, Canada, L8N 2B6 | |
| Principal Investigator: Site Reference ID/Investigator# 69122 | |
| Site Reference ID/Investigator# 69104 | Recruiting |
| Kamloops, Canada, V2C 6G6 | |
| Principal Investigator: Site Reference ID/Investigator# 69104 | |
| Site Reference ID/Investigator# 76736 | Recruiting |
| Markham, Canada, L3P 1A8 | |
| Principal Investigator: Site Reference ID/Investigator# 76736 | |
| Site Reference ID/Investigator# 81876 | Recruiting |
| Milton, Canada, L9T 2N2 | |
| Principal Investigator: Site Reference ID/Investigator# 81876 | |
| Site Reference ID/Investigator# 69110 | Recruiting |
| Mississauga, Canada, L5B 4A2 | |
| Principal Investigator: Site Reference ID/Investigator# 69110 | |
| Site Reference ID/Investigator# 69100 | Recruiting |
| Montreal, Canada, H2L 1S6 | |
| Principal Investigator: Site Reference ID/Investigator# 69100 | |
| Site Reference ID/Investigator# 69127 | Recruiting |
| Montreal, Canada, H3T 1Y3 | |
| Principal Investigator: Site Reference ID/Investigator# 69127 | |
| Site Reference ID/Investigator# 69091 | Recruiting |
| Ottawa, Canada, K2P 1V3 | |
| Principal Investigator: Site Reference ID/Investigator# 69091 | |
| Site Reference ID/Investigator# 69090 | Recruiting |
| Outremont, Canada, H2V 3Z5 | |
| Principal Investigator: Site Reference ID/Investigator# 69090 | |
| Site Reference ID/Investigator# 69123 | Recruiting |
| Owen Sound, Canada, N4K 6M9 | |
| Principal Investigator: Site Reference ID/Investigator# 69123 | |
| Site Reference ID/Investigator# 69128 | Recruiting |
| Penticton, Canada, V2A 3G8 | |
| Principal Investigator: Site Reference ID/Investigator# 69128 | |
| Site Reference ID/Investigator# 69087 | Recruiting |
| Quebec, Canada, G1V 4G2 | |
| Principal Investigator: Site Reference ID/Investigator# 69087 | |
| Site Reference ID/Investigator# 69097 | Recruiting |
| Rimouski, Canada, G5L 8W1 | |
| Principal Investigator: Site Reference ID/Investigator# 69097 | |
| Site Reference ID/Investigator# 45622 | Recruiting |
| St. John's, Canada, A1A 5E8 | |
| Principal Investigator: Site Reference ID/Investigator# 45622 | |
| Site Reference ID/Investigator# 69111 | Recruiting |
| Sydney, Canada, B1S 3N1 | |
| Principal Investigator: Site Reference ID/Investigator# 69111 | |
| Site Reference ID/Investigator# 69388 | Recruiting |
| Toronto, Canada, M4S 2C6 | |
| Principal Investigator: Site Reference ID/Investigator# 69388 | |
| Site Reference ID/Investigator# 69109 | Recruiting |
| Toronto, Canada, M9C 5N2 | |
| Principal Investigator: Site Reference ID/Investigator# 69109 | |
| Site Reference ID/Investigator# 69112 | Recruiting |
| Trois-Rivieres, Canada, G8Z 1Y2 | |
| Principal Investigator: Site Reference ID/Investigator# 69112 | |
| Site Reference ID/Investigator# 69131 | Recruiting |
| Vancouver, Canada, V6Z 2E8 | |
| Principal Investigator: Site Reference ID/Investigator# 69131 | |
| Site Reference ID/Investigator# 69085 | Recruiting |
| Victoria, Canada, V8P 5P6 | |
| Principal Investigator: Site Reference ID/Investigator# 69085 | |
| Site Reference ID/Investigator# 69113 | Recruiting |
| Winnipeg, Canada, R3A 1M3 | |
| Principal Investigator: Site Reference ID/Investigator# 69113 | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
CATO Research Canada
JSS Medical Research Inc.
Investigators
| Study Director: | Linda Assouline, PhD | AbbVie |
More Information
Additional Information:
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01559038 History of Changes |
| Other Study ID Numbers: | P12-666 |
| Study First Received: | March 19, 2012 |
| Last Updated: | May 17, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by AbbVie:
|
Assessing Effectiveness in Psoriatic Arthritis |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spondylitis Spinal Diseases |
Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases Antirheumatic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013