Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Ankylosing Spondylitis (Complete-AS)

December 7, 2020 updated by: AbbVie (prior sponsor, Abbott)

Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Ankylosing Spondylitis (Complete - AS)

The current study will assess the real - life effectiveness of adalimumab in the management of Ankylosing Spondylitis (AS) with emphasis on the prevention and management of extra-articular manifestations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
722

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2P 0V2
        • Rheumatology Clinic /ID# 54768
      • Calgary, Alberta, Canada, T2P 3C5
        • Associate Clinic /ID# 64274
    • British Columbia
      • Cranbrook, British Columbia, Canada, V1C 2R7
        • Pont, Cranbrook, BC, CA /ID# 55242
      • Kamloops, British Columbia, Canada, V2C 0B8
        • Dr. Barbara T. Blumenauer Inc. /ID# 55226
      • Kamloops, British Columbia, Canada, V2C 6G6
        • Hudson, Kamloops, Canada /ID# 54577
      • Nanaimo, British Columbia, Canada, V9S 4S1
        • Dr. Maqbool R. Sheriff Inc. /ID# 55247
      • Penticton, British Columbia, Canada, V2A 3G7
        • Stewart, Penticton, CA /ID# 67096
      • Prince George, British Columbia, Canada, V2L 5R6
        • Dr. Michael Buchanan, Inc. /ID# 55227
      • Richmond, British Columbia, Canada, V6X 2C7
        • Dr. J. Antonio Avina-Zubieta /ID# 68263
      • Vancouver, British Columbia, Canada, V6Z 2E8
        • Dr. Alfonso Verdejo Inc. /ID# 54572
      • Victoria, British Columbia, Canada, V8P 5P6
        • Dr. Milton F. Baker Inc. /ID# 55197
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A IM3
        • Manitoba Clinic /ID# 54580
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 6H5
        • Bulleid Henderson Prof. Corp. /ID# 55256
      • Fredericton, New Brunswick, Canada, E3B 6H5
        • Ecker, Fredericton, CA /ID# 54748
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 5E8
        • Nexus Clinical Research /ID# 54757
      • St. John's, Newfoundland and Labrador, Canada, A1C 5B8
        • St. Clare's Mercy Hospital /ID# 54767
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Qe Ii Hsc /Id# 55261
      • Sydney, Nova Scotia, Canada, B1S 3N1
        • Dr. Juris Lazovskis Inc. /ID# 61562
    • Ontario
      • Ancaster, Ontario, Canada, L9G 3K9
        • Pavlova, Hamilton, CA /ID# 65011
      • Barrie, Ontario, Canada, L4M 6L2
        • Waterside Clinique /ID# 72174
      • Brampton, Ontario, Canada, L6T 3J1
        • Joshi, Brampton, Canada /ID# 54758
      • Brockville, Ontario, Canada, K6V 5J9
        • Brockville Medical Center /ID# 65502
      • Burlington, Ontario, Canada, L7L 0B7
        • Dr. Sanjay Dixit Medicine Professional Corporation /ID# 67347
      • Burlington, Ontario, Canada, L7R 1E2
        • Aviva Clinical Trial Group /ID# 54764
      • Dundas, Ontario, Canada, L9H 1B7
        • Dr. Chrisotomor Kouroukis & Dr /ID# 137831
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Charlton Medical Centre /ID# 133072
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Charlton Medical Centre /ID# 55417
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Dr. William G. Bensen Centre /ID# 54762
      • Hamilton, Ontario, Canada, L9C 5N2
        • West Mountain Medical Center /ID# 128877
      • Kitchener, Ontario, Canada, N2M 5N6
        • KW Musculoskeletal Research /ID# 70093
      • Mississauga, Ontario, Canada, L5A 3V8
        • Brandusa Florica Med Prof Corp /ID# 81877
      • Mississauga, Ontario, Canada, L5A 3V8
        • Montgomery, Mississauga, CA /ID# 54581
      • Mississauga, Ontario, Canada, L5M 2V8
        • Credit Valley Rheumatology /ID# 54750
      • Mississauga, Ontario, Canada, L5M 4N4
        • Imtiaz MS Khan Medicine Prof /ID# 55401
      • Nepean, Ontario, Canada, K2G 6E2
        • Morassut, Nepean, Canada /ID# 55410
      • Newmarket, Ontario, Canada, L3Y 3R7
        • The Arthritis Program Res Grp /ID# 54755
      • Niagara Falls, Ontario, Canada, L2E 6A6
        • Rajwinder S. Dhillon Medicine /ID# 138671
      • Ottawa, Ontario, Canada, K2A 3Z3
        • Kapur, Ottawa, Canada /ID# 55397
      • Ottawa, Ontario, Canada, K2P 1V3
        • Davis, Ottawa, CA /ID# 55296
      • Owen Sound, Ontario, Canada, N4K 1S4
        • Setty, Owen Sound, CA /ID# 54583
      • St. Catharines, Ontario, Canada, L2N 7E4
        • Niagara Peninsula Arthritis Ct /ID# 67282
      • Toronto, Ontario, Canada, M4S 2C6
        • Pedvis Med Prof Corp /ID# 55411
      • Toronto, Ontario, Canada, M4X 1W4
        • Hamilton, Toronto, CA /ID# 54575
      • Toronto, Ontario, Canada, M6S 4W4
        • Jonathan Stein Med Prof Corp /ID# 55451
      • Toronto, Ontario, Canada, M9C 5N2
        • Karasik, Toronto, CA /ID# 54751
      • Toronto, Ontario, Canada, M9V 4B8
        • Dr. Samuel K Silverberg /ID# 55449
    • Quebec
      • Laval, Quebec, Canada, H7T 2Z8
        • Ctr de Med Sportive de Laval /ID# 54576
      • Montreal, Quebec, Canada, H2L 1S6
        • Institut de Rhum. de Montreal /ID# 54761
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital /ID# 63655
      • Montreal, Quebec, Canada, H3T 1Y3
        • PSS Medical Inc. /ID# 54754
      • Outremont, Quebec, Canada, H2V 3Z5
        • Couture, Outremont, CA /ID# 54574
      • Rimouski, Quebec, Canada, G5L 8W1
        • Ctr. de Rheum de l'est du QC /ID# 54765
      • Saint-leonard, Quebec, Canada, H1S 3A9
        • Clinique Medicale Langelier /ID# 55460
      • Sainte-foy, Quebec, Canada, G1V 3M7
        • Groupe de Recherche en Maladies Osseuses /ID# 45623
      • Trois-rivières, Quebec, Canada, G8Z 1Y2
        • Ctr. de Recherche Musculo-Sque /ID# 55469
      • Westmount, Quebec, Canada, H3Z 2Z3
        • Rheum Disease Ctr of Montreal /ID# 143963

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Offices of community rheumatologists

Description

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 Ankylosing Spondylitis as per the judgment of the treating physician
  • Inadequate response or non tolerant to current NSAID (Nonsteroidal Anti-Inflammatory Drug) or DMARD (Disease-Modifying Anti Rheumatic Drug) based treatment for AS

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-TNF (Tumor Necrosis Factor) or other biologic agent
  • Presence of other condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of AS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Non-Biologic arm
Patients that have not responded to the current treatment with an NSAID (Nonsteroidal Anti-Inflammatory Drug) and/or non - biologic DMARD (Disease-Modifying Anti Rheumatic Drug) for peripheral joint involvement and switch to or addition of another NSAID /DMARDS
Biologic arm
Patients that have not responded to the current treatment with non biologic DMARDS (Disease-Modifying Anti Rheumatic Drug) /NSAID (Nonsteroidal Anti-Inflammatory Drug) and switch to or addition of adalimumab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Uveitis
Time Frame: Every 3 months up to 6 months, then every 6 months up to 24 months
Baseline will be assessed as follows: Never Present, Positive History (Not present- Complete Remission,Time since remission onset; Present- Assessment of severity using a five point Likert scale (0 = Absent (Clear for Psoriasis); 5 = Most Severe)) Follow-up visits will be assessed as follows:Not present (Never present, Complete remission) Present (New Onset or Recurrence, Assessment of severity using a five point Likert scale (0 = Absent; 5 = Most Severe))
Every 3 months up to 6 months, then every 6 months up to 24 months
Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Psoriasis
Time Frame: Every 3 months up to 6 months, then every 6 months up to 24 months
Baseline will be assessed as follows: Never Present, Positive History (Not present- Complete Remission,Time since remission onset; Present- Assessment of severity using a five point Likert scale (0 = Absent (Clear for Psoriasis); 5 = Most Severe)) Follow-up visits will be assessed as follows:Not present (Never present, Complete remission) Present (New Onset or Recurrence, Assessment of severity using a five point Likert scale (0 = Absent; 5 = Most Severe))
Every 3 months up to 6 months, then every 6 months up to 24 months
Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Inflammatory Bowel Disease
Time Frame: Every 3 months up to 6 months, then every 6 months up to 24 months
Baseline will be assessed as follows: Never Present, Positive History (Not present- Complete Remission,Time since remission onset; Present- Assessment of severity using a five point Likert scale (0 = Absent (Clear for Psoriasis); 5 = Most Severe)) Follow-up visits will be assessed as follows:Not present (Never present, Complete remission) Present (New Onset or Recurrence, Assessment of severity using a five point Likert scale (0 = Absent; 5 = Most Severe))
Every 3 months up to 6 months, then every 6 months up to 24 months
Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Enthesitis of the Heel: Achilles Tendon and Plantar Fascia
Time Frame: Every 3 months up to 6 months, then every 6 months up to 24 months
Baseline will be assessed as follows: Never Present, Positive History (Not present- Complete Remission,Time since remission onset; Present- Assessment of severity using a five point Likert scale (0 = Absent (Clear for Psoriasis); 5 = Most Severe)) Follow-up visits will be assessed as follows:Not present (Never present, Complete remission) Present (New Onset or Recurrence, Assessment of severity using a five point Likert scale (0 = Absent; 5 = Most Severe))
Every 3 months up to 6 months, then every 6 months up to 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
BASFI (Bath AS Functional Assay)
Time Frame: Every 3 months up to 6 months, then every 6 months up to 24 months
This is a 100 VAS with 0 indicating lowest functional limitations and 10 highest functional limitations
Every 3 months up to 6 months, then every 6 months up to 24 months
PASQ (Psoriasis and Arthritis Screening Questionnaire)
Time Frame: Every 3 months up to 6 months, then every 6 months up to 24 months
This is an 11 item tool that ascertains self reported presence of joint pain and swelling.
Every 3 months up to 6 months, then every 6 months up to 24 months
BASDAI (Bath AS Disease Activity Index)
Time Frame: Every 3 months up to 6 months, then every 6 months up to 24 months
This is a 100 VAS with 0 indicating lowest disease activity and 10 highest disease activity
Every 3 months up to 6 months, then every 6 months up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie (prior sponsor, Abbott)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cato Research
JSS Medical Research Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 29, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P12-672

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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