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Completed

NCT Number: NCT01559038

Canadian Humira Post Marketing Observational Epidemiological Study Assessing Effectiveness in Psoriatic Arthritis

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).

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Key information

Conditions

Psoriatic Arthritis Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pont, Cranbrook, BC, CA /ID# 69120, Cranbrook, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Collaborators

  • Cato Research
  • JSS Medical Research Inc.

Registry information

Official study title

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

Acronym: Complete-PsA

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Mar 21, 2012
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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