Clinical trial NCT01387815: Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Psoriasis
Official title: Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Effectiveness
Psoriasis
Observational
Prospective
Adalimumab
Traditional Systemic Agents
Topical Agents
Comparative
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Cato Research
name: JSS Medical Research Inc.
First posted: 2011-07-06
Enrollment: 662
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants receiving treatment for psoriasis with adalimumab (alone or in combination with topical agents) or, either a topical (new, not used before or being treated and not responding) or, a traditional systemic agent (not used before alone or in combination with topical agents).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With a Physician Global Assessment (PGA) Score ≤1 at Month 6
timeFrame: Month 6
Secondary outcomes:
measure: Time to Achieving PGA ≤ 1
timeFrame: Baseline, Month 3, Month 6, Month 12, Month 18, and Month 24
measure: PGA≤1: Percentage of Participants at Month 3
timeFrame: Month 3
measure: PGA≤1: Percentage of Participants at Month 12
timeFrame: Month 12
measure: PGA≤1: Percentage of Participants at Month 18
timeFrame: Month 18
measure: PGA≤1: Percentage of Participants at Month 24
timeFrame: Month 24
measure: Psoriasis and Arthritis Screening Questionnaire (PASQ) Total Score: Change From Baseline to Month 3
timeFrame: Baseline, Month 3
measure: PASQ Total Score: Change From Baseline to Month 6
timeFrame: Baseline, Month 6
measure: PASQ Total Score: Change From Baseline to Month 12
timeFrame: Baseline, Month 12
measure: PASQ Total Score: Change From Baseline to Month 18
timeFrame: Baseline, Month 18
measure: PASQ Total Score: Change From Baseline to Month 24
timeFrame: Baseline, Month 24
measure: Body Surface Area of Psoriasis Involvement: Change From Baseline to Month 6
timeFrame: Baseline, Month 6
measure: BSA of Psoriasis Involvement: Change From Baseline to Month 12
timeFrame: Baseline, Month 12
measure: BSA of Psoriasis Involvement: Change From Baseline to Month 18
timeFrame: Baseline, Month 18
measure: BSA of Psoriasis Involvement: Change From Baseline to Month 24
timeFrame: Baseline, Month 24
measure: Patient Global Assessment (PtGA) of Disease Activity Based on a Visual Analog Scale (VAS): Change From Baseline to Month 3
timeFrame: Baseline, Month 3
measure: PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 6
timeFrame: Baseline, Month 6
measure: PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 12
timeFrame: Baseline, Month 12
measure: PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 18
timeFrame: Baseline, Month 18
measure: PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 24
timeFrame: Baseline, Month 24
measure: Dermatology Quality of Life Index (DLQI) Total Score: Change From Baseline to Month 3
timeFrame: Baseline, Month 3
measure: DLQI Total Score: Change From Baseline to Month 6
timeFrame: Baseline, Month 6
measure: DLQI Total Score: Change From Baseline to Month 12
timeFrame: Baseline, Month 12
measure: DLQI Total Score: Change From Baseline to Month 18
timeFrame: Baseline, Month 18
measure: DLQI Total Score: Change From Baseline to Month 24
timeFrame: Baseline, Month 24
measure: Time to Achieving DLQI ≤1
timeFrame: Baseline, Month 3, Month 6, Month 12, Month 18, and Month 24
measure: DLQI ≤1: Percentage of Participants at Month 3
timeFrame: Month 3
measure: DLQI ≤1: Percentage of Participants at Month 6
timeFrame: Month 6
measure: DLQI ≤1: Percentage of Participants at Month 12
timeFrame: Month 12
measure: DLQI ≤1: Percentage of Participants at Month 18
timeFrame: Month 18
measure: DLQI ≤1: Percentage of Participants at Month 24
timeFrame: Month 24
measure: Beck Depression Inventory II (BDI-II): Change From Baseline to Month 6
timeFrame: Baseline, Month 6
measure: BDI-II: Change From Baseline to Month 12
timeFrame: Baseline, Month 12
measure: BDI-II: Change From Baseline to Month 24
timeFrame: Baseline, Month 24
measure: Medical Outcomes Study Short Form-12 Health Status Survey (SF-12) Mental Component Summary (MCS) Score: Change From Baseline to Month 6
timeFrame: Baseline, Month 6
measure: SF-12 MCS Score: Change From Baseline to Month 12
timeFrame: Baseline, Month 12
measure: SF-12 MCS Score: Change From Baseline to Month 24
timeFrame: Baseline, Month 24
measure: SF-12 Physical Component Summary (PCS) Score: Change From Baseline to Month 6
timeFrame: Baseline, Month 6
measure: SF-12 PCS Score: Change From Baseline to Month 12
timeFrame: Baseline, Month 12
measure: SF-12 PCS Score: Change From Baseline to Month 24
timeFrame: Baseline, Month 24
measure: Work Limitation Questionnaire (WLQ) Total Score: Change From Baseline to Month 6
timeFrame: Baseline, Month 6
measure: WLQ Total Score: Change From Baseline to Month 12
timeFrame: Baseline, Month 12
measure: WLQ Total Score: Change From Baseline to Month 24
timeFrame: Baseline, Month 24
measure: WLQ Productivity Loss Score: Change From Baseline to Month 6
timeFrame: Baseline, Month 6
measure: WLQ Productivity Loss Score: Change From Baseline to Month 12
timeFrame: Baseline, Month 12
measure: WLQ Productivity Loss Score: Change From Baseline to Month 24
timeFrame: Baseline, Month 24
measure: Healthcare Resource Utilization (HCRU): Number of Participants With Insurance for Prescription Medication at Month 6
timeFrame: Month 6
measure: HCRU: Number of Participants With Insurance for Prescription Medication at Month 12
timeFrame: Month 12
measure: HCRU: Number of Participants With Insurance for Prescription Medication at Month 24
timeFrame: Month 24
measure: HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6
timeFrame: Month 6
measure: HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12
timeFrame: Month 12
measure: HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24
timeFrame: Month 24
measure: HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for Ankylosing Spondylitis (AS) at Month 6
timeFrame: Month 6
measure: HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 12
timeFrame: Month 12
measure: HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 24
timeFrame: Month 24
measure: HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6
timeFrame: Month 6
measure: HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12
timeFrame: Month 12
measure: HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24
timeFrame: Month 24
measure: HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6
timeFrame: Month 6
measure: HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12
timeFrame: Month 12
measure: HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24
timeFrame: Month 24
measure: HCRU: Number of Participants Making Visits to Another Physician at Month 6
timeFrame: Month 6
measure: HCRU: Number of Participants Making Visits to Another Physician at Month 12
timeFrame: Month 12
measure: HCRU: Number of Participants Making Visits to Another Physician at Month 24
timeFrame: Month 24
measure: HCRU: Number of Visits to Another Physician at Month 6
timeFrame: Month 6
measure: HCRU: Number of Visits to Another Physician at Month 12
timeFrame: Month 12
measure: HCRU: Number of Visits to Another Physician at Month 24
timeFrame: Month 24
measure: HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 6
timeFrame: Month 6
measure: HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 12
timeFrame: Month 12
measure: HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 24
timeFrame: Month 24
measure: HCRU: Number of Visits to A Healthcare Professional at Month 6
timeFrame: Month 6
measure: HCRU: Number of Visits to A Healthcare Professional at Month 12
timeFrame: Month 12
measure: HCRU: Number of Visits to A Healthcare Professional at Month 24
timeFrame: Month 24
measure: HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 6
timeFrame: Month 6
measure: HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 12
timeFrame: Month 12
measure: HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 24
timeFrame: Month 24
measure: HCRU: Number of Visits to a Hospital Emergency Room at Month 6
timeFrame: Month 6
measure: HCRU: Number of Visits to a Hospital Emergency Room at Month 12
timeFrame: Month 12
measure: HCRU: Number of Visits to a Hospital Emergency Room at Month 24
timeFrame: Month 24
measure: HCRU: Number of Participants Making Use of an Ambulance Service at Month 6
timeFrame: Month 6
measure: HCRU: Number of Participants Making Use of an Ambulance Service at Month 12
timeFrame: Month 12
measure: HCRU: Number of Participants Making Use of an Ambulance Service at Month 24
timeFrame: Month 24
measure: HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 6
timeFrame: Month 6
measure: HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 12
timeFrame: Month 12
measure: HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 24
timeFrame: Month 24
measure: HCRU: Number of Complementary/Alternate Therapy Visits at Month 6
timeFrame: Month 6
measure: HCRU: Number of Complementary/Alternate Therapy Visits at Month 12
timeFrame: Month 12
measure: HCRU: Number of Complementary/Alternate Therapy Visits at Month 24
timeFrame: Month 24
measure: HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 6
timeFrame: Month 6
measure: HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 12
timeFrame: Month 12
measure: HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 24
timeFrame: Month 24
measure: HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 6
timeFrame: Month 6
measure: HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 12
timeFrame: Month 12
measure: HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 24
timeFrame: Month 24
measure: HCRU: Number of Participants Admitted to the Intensive Care Unit (ICU) in the Past 4 Weeks at Month 6
timeFrame: Month 6
measure: HCRU: Number of Participants Admitted to the ICU in the Past 4 Weeks at Month 12
timeFrame: Month 12
measure: HCRU: Number of Participants Admitted to the ICU in the Past 4 Weeks at Month 24
timeFrame: Month 24
measure: HCRU: Cost of Payment for Over the Counter Medications at Month 6
timeFrame: Month 6
measure: HCRU: Cost of Payment for Over the Counter Medications at Month 12
timeFrame: Month 12
measure: HCRU: Cost of Payment for Over the Counter Medications at Month 24
timeFrame: Month 24
measure: HCRU: Cost of Payments to Healthcare Professionals at Month 6
timeFrame: Month 6
measure: HCRU: Cost of Payments to Healthcare Professionals at Month 12
timeFrame: Month 12
measure: HCRU: Cost of Payments to Healthcare Professionals at Month 24
timeFrame: Month 24
measure: HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 6
timeFrame: Month 6
measure: HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 12
timeFrame: Month 12
measure: HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 24
timeFrame: Month 24
measure: HCRU: Cost of Payments for Medical Devices at Month 6
timeFrame: Month 6
measure: HCRU: Cost of Payments for Medical Devices at Month 12
timeFrame: Month 12
measure: HCRU: Cost of Payments for Medical Devices at Month 24
timeFrame: Month 24
measure: HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 6
timeFrame: Month 6
measure: HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 12
timeFrame: Month 12
measure: HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 24
timeFrame: Month 24
measure: HCRU: Cost of Payments for Transportation at Month 6
timeFrame: Month 6
measure: HCRU: Cost of Payments for Transportation at Month 12
timeFrame: Month 12
measure: HCRU: Cost of Payments for Transportation at Month 24
timeFrame: Month 24
measure: Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3
timeFrame: Month 3
measure: Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6
timeFrame: Month 6
measure: Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12
timeFrame: Month 12
measure: Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18
timeFrame: Month 18
measure: Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24
timeFrame: Month 24
measure: Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 3
timeFrame: Month 3
measure: Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 6
timeFrame: Month 6
measure: Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 12
timeFrame: Month 12
measure: Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 18
timeFrame: Month 18
measure: Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 24
timeFrame: Month 24
measure: Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3
timeFrame: Month 3
measure: Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6
timeFrame: Month 6
measure: Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12
timeFrame: Month 12
measure: Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18
timeFrame: Month 18
measure: Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24
timeFrame: Month 24
measure: Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3
timeFrame: Month 3
measure: Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6
timeFrame: Month 6
measure: Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12
timeFrame: Month 12
measure: Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18
timeFrame: Month 18
measure: Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24
timeFrame: Month 24
measure: Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 3
timeFrame: Month 3
measure: Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 6
timeFrame: Month 6
measure: Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 12
timeFrame: Month 12
measure: Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 18
timeFrame: Month 18
measure: Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 24
timeFrame: Month 24
measure: Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 3
timeFrame: Month 3
measure: Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 6
timeFrame: Month 6
measure: Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 12
timeFrame: Month 12
measure: Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 18
timeFrame: Month 18
measure: Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 24
timeFrame: Month 24
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Kirk Barber Research, CA /ID# 57722
state: Alberta
city: Calgary
country: Canada
facility: Richmond Road Diagnostic Treat /ID# 70913
state: Alberta
city: Calgary
country: Canada
facility: Institute for Skin Advancement /ID# 66782
state: Alberta
city: Edmonton
country: Canada
facility: Thomas Nakatsui P.C. /ID# 55080
state: Alberta
city: Edmonton
country: Canada
facility: Alberta DermaSurgery Centre /ID# 75513
state: Alberta
city: Nanaimo
country: Canada
facility: Wellington Medical Clinic Ltd. /ID# 55083
state: British Columbia
city: Victoria
country: Canada
facility: Percuro Clinical Research, Ltd /ID# 54563
state: British Columbia
city: Brandon
country: Canada
facility: Jason Ronald Sneath Medical Co /ID# 138026
state: Manitoba
city: Winnipeg
country: Canada
facility: Winnipeg Clinic, Manitoba, CA /ID# 56865
state: Manitoba
city: Bathurst
country: Canada
facility: Maritime Medical Reseach Cente /ID# 128775
state: New Brunswick
city: Fredericton
country: Canada
facility: Dr. Irina Turchin PC Inc. /ID# 66029
state: New Brunswick
city: Moncton
country: Canada
facility: Dermatologue Inc. /ID# 76074
state: New Brunswick
city: Quispamsis
country: Canada
facility: Douglas N. Keeling MD Dermatol /ID# 55098
state: New Brunswick
city: St. John's
country: Canada
facility: Karma Clinical Trials /ID# 55101
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Nexus Clinical Research /ID# 56403
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Eastern Canada Cutaneous Resea /ID# 46353
state: Nova Scotia
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical /ID# 96915
state: Ontario
city: Etobicoke
country: Canada
facility: Kingsway Clinical Research /ID# 97255
state: Ontario
city: Hamilton
country: Canada
facility: Dermatrials Research /ID# 124138
state: Ontario
city: London
country: Canada
facility: Dr. Wei Jing Loo Medicine Prof /ID# 127546
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc. /ID# 63206
state: Ontario
city: Mississauga
country: Canada
facility: Toronto Regional Wound Healing /ID# 55135
state: Ontario
city: Mississauga
country: Canada
facility: Dr. Anna Hinek Medicine Prof /ID# 148305
state: Ontario
city: Oakville
country: Canada
facility: Oakville Derma and Laser, CA /ID# 55130
state: Ontario
city: Peterborough
country: Canada
facility: Dr. Melinda Gooderham Medicine /ID# 54566
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology Center /ID# 127786
state: Ontario
city: St-catharines
country: Canada
facility: Specialized Dermatology Inc. /ID# 64031
state: Ontario
city: Sudbury
country: Canada
facility: Giroux, Sudbury, CA /ID# 55128
state: Ontario
city: Thornhill
country: Canada
facility: Lori Shapiro Medicine Prof Inc /ID# 55126
state: Ontario
city: Toronto
country: Canada
facility: Toronto Dermatology Centre /ID# 55127
state: Ontario
city: Drummondville
country: Canada
facility: Dr. Isabelle Delorme Inc. /ID# 57791
state: Quebec
city: Montreal
country: Canada
facility: Dre. Angelique Gagne-Henley /ID# 125204
state: Quebec
city: Pierrefonds
country: Canada
facility: Dr. Loukia-Maria Mitsos /ID# 124156
state: Quebec
city: Verdun
country: Canada
facility: Dermatologie Sima Inc. /ID# 54922
state: Quebec
city: Westmount
country: Canada
facility: Dr. Beatrice Wang /ID# 63242
state: Quebec
city: Saskatoon
country: Canada
facility: Royal Univ. Hosp, Saskatoon,CA /ID# 74613
state: Saskatchewan
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: