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

NCT01387815 | Completed Results FDA Drug

• 1 other identifier: P12-678
• Study Type: observational
• Target: 662
• Locations: 1 country
• Sites: 36

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.

Conditions

Psoriasis

Keywords

Effectiveness; Psoriasis; Observational; Prospective; Adalimumab; Traditional Systemic Agents; Topical Agents; Comparative

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Physician Global Assessment (PGA) Score ≤1 at 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.

  Month 6

Secondary Outcomes (144)

• Time to Achieving PGA ≤ 1

  Baseline, Month 3, Month 6, Month 12, Month 18, and Month 24

• PGA≤1: Percentage of Participants at Month 3

  Month 3

• PGA≤1: Percentage of Participants at Month 12

  Month 12

• PGA≤1: Percentage of Participants at Month 18

  Month 18

• PGA≤1: Percentage of Participants at Month 24

  Month 24

Study Arms (2)

Topical/Traditional Systemic Agent

Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.

Adalimumab

Participants treated with adalimumab alone or in combination with topical agents.

Biological: Adalimumab

Interventions

Adalimumab BIOLOGICAL

Adalimumab administered by subcutaneous injection.

Also known as: Humira

Adalimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• Cato Research: collaborator
• JSS Medical Research Inc.: collaborator

Study Sites (36)

Kirk Barber Research, CA /ID# 57722

Calgary, Alberta, T2G 1B1, Canada

Location

Richmond Road Diagnostic Treat /ID# 70913

Calgary, Alberta, T2T 5C7, Canada

Location

Institute for Skin Advancement /ID# 66782

Calgary, Alberta, T3A 2N1, Canada

Location

Thomas Nakatsui P.C. /ID# 55080

Edmonton, Alberta, T5N 4B2, Canada

Location

Alberta DermaSurgery Centre /ID# 75513

Edmonton, Alberta, T6G 1C3, Canada

Location

Wellington Medical Clinic Ltd. /ID# 55083

Nanaimo, British Columbia, V9T 1W1, Canada

Location

Percuro Clinical Research, Ltd /ID# 54563

Victoria, British Columbia, V8V 3M9, Canada

Location

Jason Ronald Sneath Medical Co /ID# 138026

Brandon, Manitoba, R7A 0L5, Canada

Location

Winnipeg Clinic, Manitoba, CA /ID# 56865

Winnipeg, Manitoba, R3C 1T6, Canada

Location

Maritime Medical Reseach Cente /ID# 128775

Bathurst, New Brunswick, E2A 4X7, Canada

Location

Dr. Irina Turchin PC Inc. /ID# 66029

Fredericton, New Brunswick, E3B 1G9, Canada

Location

Dermatologue Inc. /ID# 76074

Moncton, New Brunswick, E1C 8X3, Canada

Location

Douglas N. Keeling MD Dermatol /ID# 55098

Quispamsis, New Brunswick, E2E 4Z4, Canada

Location

Karma Clinical Trials /ID# 55101

St. John's, Newfoundland and Labrador, A1A 4Y3, Canada

Location

Nexus Clinical Research /ID# 56403

St. John's, Newfoundland and Labrador, A1B 5E8, Canada

Location

Eastern Canada Cutaneous Resea /ID# 46353

Halifax, Nova Scotia, B3H 0A2, Canada

Location

SimcoDerm Medical and Surgical /ID# 96915

Barrie, Ontario, L4M 7G1, Canada

Location

Kingsway Clinical Research /ID# 97255

Etobicoke, Ontario, M8X 1Y9, Canada

Location

Giroux, Sudbury, CA /ID# 55128

Greater Sudbury, Ontario, P3C 1X8, Canada

Location

Dermatrials Research /ID# 124138

Hamilton, Ontario, L8N 1Y2, Canada

Location

Dr. Wei Jing Loo Medicine Prof /ID# 127546

London, Ontario, N6H 5L5, Canada

Location

Lynderm Research Inc. /ID# 63206

Markham, Ontario, L3P 1X2, Canada

Location

Toronto Regional Wound Healing /ID# 55135

Mississauga, Ontario, L4Y 1A6, Canada

Location

Dr. Anna Hinek Medicine Prof /ID# 148305

Mississauga, Ontario, L5M 2V8, Canada

Location

Oakville Derma and Laser, CA /ID# 55130

Oakville, Ontario, L6J 7W5, Canada

Location

Dr. Melinda Gooderham Medicine /ID# 54566

Peterborough, Ontario, K9J 5K2, Canada

Location

York Dermatology Center /ID# 127786

Richmond Hill, Ontario, L4C 9M7, Canada

Location

Specialized Dermatology Inc. /ID# 64031

St. Catharines, Ontario, L2R 5W4, Canada

Location

Lori Shapiro Medicine Prof Inc /ID# 55126

Thornhill, Ontario, L4J 3M6, Canada

Location

Toronto Dermatology Centre /ID# 55127

Toronto, Ontario, M3H 5Y8, Canada

Location

Dr. Isabelle Delorme Inc. /ID# 57791

Drummondville, Quebec, J2B 5L4, Canada

Location

Dre. Angelique Gagne-Henley /ID# 125204

Montreal, Quebec, J7Z 3B8, Canada

Location

Dr. Loukia-Maria Mitsos /ID# 124156

Pierrefonds, Quebec, H8Z 1W5, Canada

Location

Dermatologie Sima Inc. /ID# 54922

Verdun, Quebec, H4G 3E7, Canada

Location

Dr. Beatrice Wang /ID# 63242

Westmount, Quebec, H3Z 2S6, Canada

Location

Royal Univ. Hosp, Saskatoon,CA /ID# 74613

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: July 6, 2011
• Study Start: August 16, 2011
• Primary Completion: June 29, 2018
• Study Completion: June 29, 2018
• Last Updated: December 5, 2019
• Results First Posted: December 5, 2019

Record last verified: 2019-11

Locations

CA (36)