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Clinical Trials/NCT01387815
NCT01387815CompletedNot Applicable

Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Psoriasis

AbbVie (prior sponsor, Abbott)36 sites in 1 country662 target enrollmentStarted: August 16, 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
662
Locations
36
Primary Endpoint
Percentage of Participants With a Physician Global Assessment (PGA) Score ≤1 at Month 6
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This was a Canadian post-marketing observational study (PMOS) utilizing a prospective cohort design that compared the real - life effectiveness of adalimumab to topical and traditional systemic agents in the management of psoriasis and its impact on the patient's quality of life and societal burden of illness.

Detailed Description

This was a Canadian post-marketing observational study (PMOS) utilizing a prospective cohort design. Participants were entered into one of two study cohorts (adalimumab cohort or topical/traditional systemic cohort) at the time of change of their psoriasis treatment for any reason and were followed for a maximum of 24 months with recommended assessments at 3, 6, 12, 18 and 24 months after baseline. Treatment of the participants and follow up were according to the physician's judgment, regional regulations, and the product monograph. Off-label use was not permitted, and these participants were not included in the study. Dose changes including escalation were allowed as per the physician's judgment for participants that were treated as per indication when they were enrolled in the study.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Active moderate or severe plaque psoriasis according to the judgment of the treating physician.
  • •The treating physician has decided to change the current treatment or add additional treatments for any reason including but not limited to inadequate response, intolerance, sub-optimal compliance or participant preference.

Exclusion Criteria

  • •Had currently participated in another prospective study with similar objectives.
  • •Participant could not or would not sign informed consent.
  • •Presence of other condition that, in the opinion of the treating physician, prohibits the participant from participating in the study or obscured the assessment of the treatment of plaque psoriasis.

Outcomes

Primary Outcomes

Percentage of Participants With a Physician Global Assessment (PGA) Score ≤1 at Month 6

Time Frame: Month 6

The Physician global assessment (PGA) score is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories: * 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present; * 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation; * 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation; * 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation; * 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation; * 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation. A higher score indicates greater disease severity. Percentages based on the total number of intent to treat (ITT) participants who attended each visit.

Secondary Outcomes

  • PGA≤1: Percentage of Participants at Month 24(Month 24)
  • PGA≤1: Percentage of Participants at Month 3(Month 3)
  • PGA≤1: Percentage of Participants at Month 18(Month 18)
  • Time to Achieving PGA ≤ 1(Baseline, Month 3, Month 6, Month 12, Month 18, and Month 24)
  • Psoriasis and Arthritis Screening Questionnaire (PASQ) Total Score: Change From Baseline to Month 3(Baseline, Month 3)
  • PASQ Total Score: Change From Baseline to Month 6(Baseline, Month 6)
  • PASQ Total Score: Change From Baseline to Month 12(Baseline, Month 12)
  • PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 12(Baseline, Month 12)
  • PGA≤1: Percentage of Participants at Month 12(Month 12)
  • PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 6(Baseline, Month 6)
  • PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 18(Baseline, Month 18)
  • PASQ Total Score: Change From Baseline to Month 24(Baseline, Month 24)
  • BSA of Psoriasis Involvement: Change From Baseline to Month 18(Baseline, Month 18)
  • DLQI Total Score: Change From Baseline to Month 18(Baseline, Month 18)
  • Time to Achieving DLQI ≤1(Baseline, Month 3, Month 6, Month 12, Month 18, and Month 24)
  • DLQI ≤1: Percentage of Participants at Month 6(Month 6)
  • PASQ Total Score: Change From Baseline to Month 18(Baseline, Month 18)
  • Patient Global Assessment (PtGA) of Disease Activity Based on a Visual Analog Scale (VAS): Change From Baseline to Month 3(Baseline, Month 3)
  • DLQI Total Score: Change From Baseline to Month 12(Baseline, Month 12)
  • SF-12 MCS Score: Change From Baseline to Month 12(Baseline, Month 12)
  • SF-12 Physical Component Summary (PCS) Score: Change From Baseline to Month 6(Baseline, Month 6)
  • SF-12 PCS Score: Change From Baseline to Month 12(Baseline, Month 12)
  • Body Surface Area of Psoriasis Involvement: Change From Baseline to Month 6(Baseline, Month 6)
  • BSA of Psoriasis Involvement: Change From Baseline to Month 12(Baseline, Month 12)
  • BSA of Psoriasis Involvement: Change From Baseline to Month 24(Baseline, Month 24)
  • PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 24(Baseline, Month 24)
  • DLQI Total Score: Change From Baseline to Month 6(Baseline, Month 6)
  • DLQI ≤1: Percentage of Participants at Month 24(Month 24)
  • Beck Depression Inventory II (BDI-II): Change From Baseline to Month 6(Baseline, Month 6)
  • Dermatology Quality of Life Index (DLQI) Total Score: Change From Baseline to Month 3(Baseline, Month 3)
  • DLQI Total Score: Change From Baseline to Month 24(Baseline, Month 24)
  • DLQI ≤1: Percentage of Participants at Month 3(Month 3)
  • DLQI ≤1: Percentage of Participants at Month 18(Month 18)
  • BDI-II: Change From Baseline to Month 12(Baseline, Month 12)
  • Medical Outcomes Study Short Form-12 Health Status Survey (SF-12) Mental Component Summary (MCS) Score: Change From Baseline to Month 6(Baseline, Month 6)
  • DLQI ≤1: Percentage of Participants at Month 12(Month 12)
  • WLQ Productivity Loss Score: Change From Baseline to Month 12(Baseline, Month 12)
  • HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 24(Month 24)
  • HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6(Month 6)
  • HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12(Month 12)
  • BDI-II: Change From Baseline to Month 24(Baseline, Month 24)
  • SF-12 MCS Score: Change From Baseline to Month 24(Baseline, Month 24)
  • Work Limitation Questionnaire (WLQ) Total Score: Change From Baseline to Month 6(Baseline, Month 6)
  • WLQ Total Score: Change From Baseline to Month 24(Baseline, Month 24)
  • WLQ Productivity Loss Score: Change From Baseline to Month 6(Baseline, Month 6)
  • SF-12 PCS Score: Change From Baseline to Month 24(Baseline, Month 24)
  • WLQ Total Score: Change From Baseline to Month 12(Baseline, Month 12)
  • HCRU: Number of Participants With Insurance for Prescription Medication at Month 12(Month 12)
  • HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24(Month 24)
  • Healthcare Resource Utilization (HCRU): Number of Participants With Insurance for Prescription Medication at Month 6(Month 6)
  • HCRU: Number of Visits to A Healthcare Professional at Month 24(Month 24)
  • HCRU: Number of Participants Making Use of an Ambulance Service at Month 6(Month 6)
  • HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 12(Month 12)
  • HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24(Month 24)
  • HCRU: Number of Participants Making Visits to Another Physician at Month 24(Month 24)
  • WLQ Productivity Loss Score: Change From Baseline to Month 24(Baseline, Month 24)
  • HCRU: Number of Participants With Insurance for Prescription Medication at Month 24(Month 24)
  • HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6(Month 6)
  • HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12(Month 12)
  • HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6(Month 6)
  • HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for Ankylosing Spondylitis (AS) at Month 6(Month 6)
  • HCRU: Number of Participants Making Visits to Another Physician at Month 6(Month 6)
  • HCRU: Number of Participants Making Visits to Another Physician at Month 12(Month 12)
  • HCRU: Number of Visits to A Healthcare Professional at Month 6(Month 6)
  • HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12(Month 12)
  • HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24(Month 24)
  • HCRU: Number of Visits to Another Physician at Month 24(Month 24)
  • HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 6(Month 6)
  • HCRU: Number of Visits to Another Physician at Month 6(Month 6)
  • HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 12(Month 12)
  • HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 24(Month 24)
  • HCRU: Number of Visits to Another Physician at Month 12(Month 12)
  • HCRU: Number of Visits to a Hospital Emergency Room at Month 12(Month 12)
  • HCRU: Number of Visits to a Hospital Emergency Room at Month 24(Month 24)
  • HCRU: Number of Visits to A Healthcare Professional at Month 12(Month 12)
  • HCRU: Number of Participants Making Use of an Ambulance Service at Month 12(Month 12)
  • HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 6(Month 6)
  • HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 6(Month 6)
  • HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 12(Month 12)
  • HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 24(Month 24)
  • HCRU: Number of Visits to a Hospital Emergency Room at Month 6(Month 6)
  • HCRU: Number of Participants Making Use of an Ambulance Service at Month 24(Month 24)
  • HCRU: Cost of Payment for Over the Counter Medications at Month 24(Month 24)
  • HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 12(Month 12)
  • HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 24(Month 24)
  • Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3(Month 3)
  • HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 12(Month 12)
  • HCRU: Number of Complementary/Alternate Therapy Visits at Month 24(Month 24)
  • HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 24(Month 24)
  • HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 24(Month 24)
  • HCRU: Number of Participants Admitted to the ICU in the Past 4 Weeks at Month 12(Month 12)
  • HCRU: Number of Participants Admitted to the ICU in the Past 4 Weeks at Month 24(Month 24)
  • HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 24(Month 24)
  • HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 6(Month 6)
  • HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 12(Month 12)
  • HCRU: Cost of Payments to Healthcare Professionals at Month 6(Month 6)
  • HCRU: Cost of Payments to Healthcare Professionals at Month 12(Month 12)
  • HCRU: Number of Complementary/Alternate Therapy Visits at Month 6(Month 6)
  • HCRU: Number of Complementary/Alternate Therapy Visits at Month 12(Month 12)
  • HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 6(Month 6)
  • HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 12(Month 12)
  • HCRU: Cost of Payment for Over the Counter Medications at Month 6(Month 6)
  • HCRU: Cost of Payment for Over the Counter Medications at Month 12(Month 12)
  • HCRU: Number of Participants Admitted to the Intensive Care Unit (ICU) in the Past 4 Weeks at Month 6(Month 6)
  • HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 6(Month 6)
  • HCRU: Cost of Payments for Transportation at Month 12(Month 12)
  • Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6(Month 6)
  • Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 6(Month 6)
  • HCRU: Cost of Payments to Healthcare Professionals at Month 24(Month 24)
  • HCRU: Cost of Payments for Transportation at Month 24(Month 24)
  • Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12(Month 12)
  • Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12(Month 12)
  • Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18(Month 18)
  • HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 6(Month 6)
  • HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 12(Month 12)
  • HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 24(Month 24)
  • Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18(Month 18)
  • HCRU: Cost of Payments for Medical Devices at Month 12(Month 12)
  • HCRU: Cost of Payments for Transportation at Month 6(Month 6)
  • Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 12(Month 12)
  • HCRU: Cost of Payments for Medical Devices at Month 6(Month 6)
  • HCRU: Cost of Payments for Medical Devices at Month 24(Month 24)
  • Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12(Month 12)
  • Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24(Month 24)
  • Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 3(Month 3)
  • Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 6(Month 6)
  • Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 18(Month 18)
  • Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 24(Month 24)
  • Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3(Month 3)
  • Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18(Month 18)
  • Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3(Month 3)
  • Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 24(Month 24)
  • Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 3(Month 3)
  • Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6(Month 6)
  • Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 12(Month 12)
  • Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 18(Month 18)
  • Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24(Month 24)
  • Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6(Month 6)
  • Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24(Month 24)
  • Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 3(Month 3)
  • Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 12(Month 12)
  • Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 18(Month 18)
  • Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 6(Month 6)
  • Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 24(Month 24)

Investigators

Sponsor
AbbVie (prior sponsor, Abbott)
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (36)

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