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

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ClinicalTrials.gov Identifier: NCT01559038
Recruitment Status : Active, not recruiting
First Posted : March 21, 2012
Last Update Posted : November 6, 2018
Sponsor:
Collaborators:
Cato Research
JSS Medical Research Inc.
Information provided by (Responsible Party):
AbbVie ( 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).

Condition or disease
Psoriatic Arthritis

Study Type : Observational
Actual Enrollment : 474 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Canadian Humira Post Marketing Observational Epidemiological Study Assessing Effectiveness in Psoriatic Arthritis (Complete-PsA)
Actual Study Start Date : February 16, 2012
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Group/Cohort
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
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



Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
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

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


  Show 40 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Cato Research
JSS Medical Research Inc.
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01559038     History of Changes
Other Study ID Numbers: P12-666
First Posted: March 21, 2012    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
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