Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Ankylosing Spondylitis

NCT ID: NCT01387802

Last Updated: 2020-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

722 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-29

Study Completion Date

2019-12-16

Brief Summary

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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.

Detailed Description

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Conditions

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Ankylosing Spondylitis

Keywords

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Assessing Effectiveness in Ankylosing Spondylitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JSS Medical Research Inc.

INDUSTRY

Sponsor Role collaborator

Cato Research

INDUSTRY

Sponsor Role collaborator

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Rheumatology Clinic /ID# 54768

Calgary, Alberta, Canada

Site Status

Associate Clinic /ID# 64274

Calgary, Alberta, Canada

Site Status

Pont, Cranbrook, BC, CA /ID# 55242

Cranbrook, British Columbia, Canada

Site Status

Dr. Barbara T. Blumenauer Inc. /ID# 55226

Kamloops, British Columbia, Canada

Site Status

Hudson, Kamloops, Canada /ID# 54577

Kamloops, British Columbia, Canada

Site Status

Dr. Maqbool R. Sheriff Inc. /ID# 55247

Nanaimo, British Columbia, Canada

Site Status

Stewart, Penticton, CA /ID# 67096

Penticton, British Columbia, Canada

Site Status

Dr. Michael Buchanan, Inc. /ID# 55227

Prince George, British Columbia, Canada

Site Status

Dr. J. Antonio Avina-Zubieta /ID# 68263

Richmond, British Columbia, Canada

Site Status

Dr. Alfonso Verdejo Inc. /ID# 54572

Vancouver, British Columbia, Canada

Site Status

Dr. Milton F. Baker Inc. /ID# 55197

Victoria, British Columbia, Canada

Site Status

Manitoba Clinic /ID# 54580

Winnipeg, Manitoba, Canada

Site Status

Bulleid Henderson Prof. Corp. /ID# 55256

Fredericton, New Brunswick, Canada

Site Status

Ecker, Fredericton, CA /ID# 54748

Fredericton, New Brunswick, Canada

Site Status

Nexus Clinical Research /ID# 54757

St. John's, Newfoundland and Labrador, Canada

Site Status

St. Clare's Mercy Hospital /ID# 54767

St. John's, Newfoundland and Labrador, Canada

Site Status

Qe Ii Hsc /Id# 55261

Halifax, Nova Scotia, Canada

Site Status

Dr. Juris Lazovskis Inc. /ID# 61562

Sydney, Nova Scotia, Canada

Site Status

Pavlova, Hamilton, CA /ID# 65011

Ancaster, Ontario, Canada

Site Status

Waterside Clinique /ID# 72174

Barrie, Ontario, Canada

Site Status

Joshi, Brampton, Canada /ID# 54758

Brampton, Ontario, Canada

Site Status

Brockville Medical Center /ID# 65502

Brockville, Ontario, Canada

Site Status

Dr. Sanjay Dixit Medicine Professional Corporation /ID# 67347

Burlington, Ontario, Canada

Site Status

Aviva Clinical Trial Group /ID# 54764

Burlington, Ontario, Canada

Site Status

Dr. Chrisotomor Kouroukis & Dr /ID# 137831

Dundas, Ontario, Canada

Site Status

Charlton Medical Centre /ID# 133072

Hamilton, Ontario, Canada

Site Status

Charlton Medical Centre /ID# 55417

Hamilton, Ontario, Canada

Site Status

Dr. William G. Bensen Centre /ID# 54762

Hamilton, Ontario, Canada

Site Status

West Mountain Medical Center /ID# 128877

Hamilton, Ontario, Canada

Site Status

KW Musculoskeletal Research /ID# 70093

Kitchener, Ontario, Canada

Site Status

Brandusa Florica Med Prof Corp /ID# 81877

Mississauga, Ontario, Canada

Site Status

Montgomery, Mississauga, CA /ID# 54581

Mississauga, Ontario, Canada

Site Status

Credit Valley Rheumatology /ID# 54750

Mississauga, Ontario, Canada

Site Status

Imtiaz MS Khan Medicine Prof /ID# 55401

Mississauga, Ontario, Canada

Site Status

Morassut, Nepean, Canada /ID# 55410

Nepean, Ontario, Canada

Site Status

The Arthritis Program Res Grp /ID# 54755

Newmarket, Ontario, Canada

Site Status

Rajwinder S. Dhillon Medicine /ID# 138671

Niagara Falls, Ontario, Canada

Site Status

Kapur, Ottawa, Canada /ID# 55397

Ottawa, Ontario, Canada

Site Status

Davis, Ottawa, CA /ID# 55296

Ottawa, Ontario, Canada

Site Status

Setty, Owen Sound, CA /ID# 54583

Owen Sound, Ontario, Canada

Site Status

Niagara Peninsula Arthritis Ct /ID# 67282

St. Catharines, Ontario, Canada

Site Status

Pedvis Med Prof Corp /ID# 55411

Toronto, Ontario, Canada

Site Status

Hamilton, Toronto, CA /ID# 54575

Toronto, Ontario, Canada

Site Status

Jonathan Stein Med Prof Corp /ID# 55451

Toronto, Ontario, Canada

Site Status

Karasik, Toronto, CA /ID# 54751

Toronto, Ontario, Canada

Site Status

Dr. Samuel K Silverberg /ID# 55449

Toronto, Ontario, Canada

Site Status

Ctr de Med Sportive de Laval /ID# 54576

Laval, Quebec, Canada

Site Status

Institut de Rhum. de Montreal /ID# 54761

Montreal, Quebec, Canada

Site Status

Jewish General Hospital /ID# 63655

Montreal, Quebec, Canada

Site Status

PSS Medical Inc. /ID# 54754

Montreal, Quebec, Canada

Site Status

Couture, Outremont, CA /ID# 54574

Outremont, Quebec, Canada

Site Status

Ctr. de Rheum de l'est du QC /ID# 54765

Rimouski, Quebec, Canada

Site Status

Clinique Medicale Langelier /ID# 55460

Saint-Léonard, Quebec, Canada

Site Status

Groupe de Recherche en Maladies Osseuses /ID# 45623

Sainte-Foy, Quebec, Canada

Site Status

Ctr. de Recherche Musculo-Sque /ID# 55469

Trois-Rivières, Quebec, Canada

Site Status

Rheum Disease Ctr of Montreal /ID# 143963

Westmount, Quebec, Canada

Site Status

Countries

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Canada

Related Links

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Other Identifiers

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P12-672

Identifier Type: -

Identifier Source: org_study_id