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Canadian Humira Post Marketing Observational Epidemiological Study Assessing Effectiveness in Psoriatic Arthritis (Complete-PsA)

This study is currently recruiting participants.
Verified October 2017 by AbbVie ( AbbVie (prior sponsor, Abbott) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT01559038
First Posted: March 21, 2012
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
JSS Medical Research Inc.
Cato Research
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
  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:


Further study details as provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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: February 16, 2012
Estimated Study Completion Date: November 30, 2019
Estimated Primary Completion Date: November 30, 2019 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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) or other biologic agent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559038


Contacts
Contact: Annie Daudrumez 514-832-7498 annie.daudrumez@abbvie.com
Contact: Josée Lafortune 514-832-7435 josee.lafortune@abbvie.com

  Show 61 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
JSS Medical Research Inc.
Cato Research
Investigators
Study Director: Christina Pelizon, MD AbbVie
  More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01559038     History of Changes
Other Study ID Numbers: P12-666
First Submitted: March 19, 2012
First Posted: March 21, 2012
Last Update Posted: October 9, 2017
Last Verified: October 2017

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Assessing Effectiveness in Psoriatic Arthritis

Additional relevant MeSH terms:
Arthritis, Psoriatic
Arthritis
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antirheumatic Agents