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Psoriatic ArthritisComplete-PsANCT01559038

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

An observational study of Psoriatic Arthritis, run by AbbVie (prior sponsor, Abbott) at 41 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Psoriatic Arthritis
How many people
483 participants
Where
41 sitesCanada
Study dates
16 Feb 2012to 19 Nov 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Offices of community rheumatologists \& dermatologists

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

Canada41 sites

  • Waterside Clinique /ID# 72173

    Barrie, Ontario, L4M 6L2

  • Shickh, Bowmanville, Canada /ID# 90513

    Bowmanville, Ontario, L1C 1P6

  • Brockville Medical Center /ID# 69105

    Brockville, Ontario, K6V 5J9

  • Dr. Sanjay Dixit Medicine Professional Corporation /ID# 69092

    Burlington, Ontario, L7L 0B7

  • Pont, Cranbrook, BC, CA /ID# 69120

    Cranbrook, British Columbia, V1C 2R7

  • Dr. Chrisotomor Kouroukis & Dr /ID# 137894

    Dundas, Ontario, L9H 1B7

  • Qe Ii Hsc /Id# 69129

    Halifax, Nova Scotia, B3H 1V7

  • Charlton Medical Centre /ID# 133073

    Hamilton, Ontario, L8N 1Y2

  • Charlton Medical Centre /ID# 69122

    Hamilton, Ontario, L8N 1Y2

  • Dr. William G. Bensen Centre /ID# 69086

    Hamilton, Ontario, L8N 1Y2

  • West Mountain Medical Center /ID# 128878

    Hamilton, Ontario, L9C 5N2

  • Dr. Barbara T. Blumenauer Inc. /ID# 75393

    Kamloops, British Columbia, V2C 0B8

  • Hudson, Kamloops, Canada /ID# 69104

    Kamloops, British Columbia, V2C 6G6

  • Lynderm Research Inc. /ID# 76736

    Markham, Ontario, L3P 1X2

  • Brandusa Florica Med Prof Corp /ID# 81876

    Mississauga, Ontario, L5A 3V8

  • Credit Valley Rheumatology /ID# 69089

    Mississauga, Ontario, L5M 2V8

  • Imtiaz MS Khan Medicine Prof /ID# 69110

    Mississauga, Ontario, L5M 4N4

  • Institut de Rhum. de Montreal /ID# 69100

    Montreal, Quebec, H2L 1S6

  • PSS Medical Inc. /ID# 69127

    Montreal, Quebec, H3T 1Y3

  • Dr. Maqbool R. Sheriff Inc. /ID# 69125

    Nanaimo, British Columbia, V9S 4S1

  • Rajwinder S. Dhillon Medicine /ID# 138672

    Niagara Falls, Ontario, L2E 6A6

  • Davis, Ottawa, CA /ID# 69091

    Ottawa, Ontario, K2P 1V3

  • Couture, Outremont, CA /ID# 69090

    Outremont, Quebec, H2V 3Z5

  • Setty, Owen Sound, CA /ID# 69123

    Owen Sound, Ontario, N4K 1S4

  • Carmi Medical Clinic /ID# 69128

    Penticton, British Columbia, V2A 3G7

  • Dr. J. Antonio Avina-Zubieta /ID# 71035

    Richmond, British Columbia, V6X 2C7

  • York Dermatology Clinic and Research Centre /ID# 127943

    Richmond Hill, Ontario, L4C 9M7

  • Ctr. de Rheum de l'est du QC /ID# 69097

    Rimouski, Quebec, G5L 8W1

  • Groupe de Recherche en Maladies Osseuses /ID# 69087

    Sainte-Foy, Quebec, G1V 3M7

  • CHUS - Hopital Fleurimont /ID# 94735

    Sherbrooke, Quebec, J1H 5N4

  • Nexus Clinical Research /ID# 45622

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

  • St. Clare's Mercy Hospital /ID# 69121

    St. John's, Newfoundland and Labrador, A1C 5B8

  • Dr. Juris Lazovskis Inc. /ID# 69111

    Sydney, Nova Scotia, B1S 3N1

  • Pedvis Med Prof Corp /ID# 69388

    Toronto, Ontario, M4S 2C6

  • Jonathan Stein Med Prof Corp /ID# 71134

    Toronto, Ontario, M6S 4W4

  • Karasik, Toronto, CA /ID# 69109

    Toronto, Ontario, M9C 5N2

  • Ctr. de Recherche Musculo-Sque /ID# 69112

    Trois-Rivières, Quebec, G8Z 1Y2

  • Dr. Alfonso Verdejo Inc. /ID# 69131

    Vancouver, British Columbia, V6Z 2E8

  • Dr. Milton F. Baker Inc. /ID# 69085

    Victoria, British Columbia, V8P 5P6

  • Rheum Disease Ctr of Montreal /ID# 143964

    Westmount, Quebec, H3Z 2Z3

  • Manitoba Clinic /ID# 69113

    Winnipeg, Manitoba, R3A IM3

Other trials in Canada

About this study

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

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).

Keywords
Assessing Effectiveness in Psoriatic Arthritis
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01559038
Study groupRoleWhat they receive
adalimumabResponding 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the Disease Activity Score - 28 (DAS-28)

    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)

    Measured: Every 3 months up to 6 months, then every 6 months up to 24 months

Secondary outcomes (5)

  1. Duration of Morning Stiffness (min)

    This is ascertained by the treating physician during the patient assessment and is measured in minutes

    Measured: Every 3 months up to 6 months, then every 6 months up to 24 months

  2. Dermatology Life Quality Index (DLQI)

    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.

    Measured: Baseline, month 6, month12, month 24

  3. Health Assessment Questionnaire - Disability Index (HAQ-DI)

    Self-administered questionnaire measuring the patient's functional ability during the last week.

    Measured: Every 3 months up to 6 months, then every 6 months up to 24 months

  4. Patient Global Assessment of Disease Activity (VAS and 5 Point Scale)

    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

    Measured: Every 3 months up to 6 months, then every 6 months up to 24 months

  5. Physician Global Assessment of Disease Activity (VAS and 5 Point Scale)

    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

    Measured: Every 3 months up to 6 months, then every 6 months up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2012 (estimated)
  2. Study start16 Feb 2012
  3. Primary completion19 Nov 2019
  4. Study completion19 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
483 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01559038
Sponsor's protocol ID
P12-666
Acronym
Complete-PsA
Status last verified
Dec 2019
First submitted
19 Mar 2012
Last updated
19 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Khraishi MM, Remple VP, Silverberg S, Stewart JC, Florica B, Bessette L. Canadian Adalimumab Postmarketing Observational Epidemiological Study Assessing Effectiveness in Psoriatic Arthritis (COMPLETE-PsA): 12-month Results of Comparative Effectiveness of Adalimumab and nbDMARDs. J Rheumatol. 2022 May;49(5):454-464. doi: 10.3899/jrheum.200609. Epub 2022 Jan 15.

    PubMed 35033999

Questions about this trial

What is this clinical trial studying?

An observational study of Psoriatic Arthritis, run by AbbVie (prior sponsor, Abbott) at 41 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01559038, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.

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