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

NCT01387802 | Completed

• 1 other identifier: P12-672
• Study Type: observational
• Target: 722
• Locations: 1 country
• Sites: 56

Brief Summary

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.

Conditions

Ankylosing Spondylitis

Keywords

Assessing Effectiveness in Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (4)

• Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Uveitis

  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

  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

  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

  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 Outcomes (3)

• BASFI (Bath AS Functional Assay)

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

• PASQ (Psoriasis and Arthritis Screening Questionnaire)

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

• BASDAI (Bath AS Disease Activity Index)

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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Offices of community rheumatologists

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (56)

Rheumatology Clinic /ID# 54768

Calgary, Alberta, T2P 0V2, Canada

Location

Associate Clinic /ID# 64274

Calgary, Alberta, T2P 3C5, Canada

Location

Pont, Cranbrook, BC, CA /ID# 55242

Cranbrook, British Columbia, V1C 2R7, Canada

Location

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

Kamloops, British Columbia, V2C 0B8, Canada

Location

Hudson, Kamloops, Canada /ID# 54577

Kamloops, British Columbia, V2C 6G6, Canada

Location

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

Nanaimo, British Columbia, V9S 4S1, Canada

Location

Stewart, Penticton, CA /ID# 67096

Penticton, British Columbia, V2A 3G7, Canada

Location

Dr. Michael Buchanan, Inc. /ID# 55227

Prince George, British Columbia, V2L 5R6, Canada

Location

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

Richmond, British Columbia, V6X 2C7, Canada

Location

Dr. Alfonso Verdejo Inc. /ID# 54572

Vancouver, British Columbia, V6Z 2E8, Canada

Location

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

Victoria, British Columbia, V8P 5P6, Canada

Location

Manitoba Clinic /ID# 54580

Winnipeg, Manitoba, R3A IM3, Canada

Location

Bulleid Henderson Prof. Corp. /ID# 55256

Fredericton, New Brunswick, E3B 6H5, Canada

Location

Ecker, Fredericton, CA /ID# 54748

Fredericton, New Brunswick, E3B 6H5, Canada

Location

Nexus Clinical Research /ID# 54757

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

Location

St. Clare's Mercy Hospital /ID# 54767

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

Location

Qe Ii Hsc /Id# 55261

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Dr. Juris Lazovskis Inc. /ID# 61562

Sydney, Nova Scotia, B1S 3N1, Canada

Location

Pavlova, Hamilton, CA /ID# 65011

Ancaster, Ontario, L9G 3K9, Canada

Location

Waterside Clinique /ID# 72174

Barrie, Ontario, L4M 6L2, Canada

Location

Joshi, Brampton, Canada /ID# 54758

Brampton, Ontario, L6T 3J1, Canada

Location

Brockville Medical Center /ID# 65502

Brockville, Ontario, K6V 5J9, Canada

Location

Dr. Sanjay Dixit Medicine Professional Corporation /ID# 67347

Burlington, Ontario, L7L 0B7, Canada

Location

Aviva Clinical Trial Group /ID# 54764

Burlington, Ontario, L7R 1E2, Canada

Location

Dr. Chrisotomor Kouroukis & Dr /ID# 137831

Dundas, Ontario, L9H 1B7, Canada

Location

Charlton Medical Centre /ID# 133072

Hamilton, Ontario, L8N 1Y2, Canada

Location

Charlton Medical Centre /ID# 55417

Hamilton, Ontario, L8N 1Y2, Canada

Location

Dr. William G. Bensen Centre /ID# 54762

Hamilton, Ontario, L8N 1Y2, Canada

Location

West Mountain Medical Center /ID# 128877

Hamilton, Ontario, L9C 5N2, Canada

Location

KW Musculoskeletal Research /ID# 70093

Kitchener, Ontario, N2M 5N6, Canada

Location

Brandusa Florica Med Prof Corp /ID# 81877

Mississauga, Ontario, L5A 3V8, Canada

Location

Montgomery, Mississauga, CA /ID# 54581

Mississauga, Ontario, L5A 3V8, Canada

Location

Credit Valley Rheumatology /ID# 54750

Mississauga, Ontario, L5M 2V8, Canada

Location

Imtiaz MS Khan Medicine Prof /ID# 55401

Mississauga, Ontario, L5M 4N4, Canada

Location

Morassut, Nepean, Canada /ID# 55410

Nepean, Ontario, K2G 6E2, Canada

Location

The Arthritis Program Res Grp /ID# 54755

Newmarket, Ontario, L3Y 3R7, Canada

Location

Rajwinder S. Dhillon Medicine /ID# 138671

Niagara Falls, Ontario, L2E 6A6, Canada

Location

Kapur, Ottawa, Canada /ID# 55397

Ottawa, Ontario, K2A 3Z3, Canada

Location

Davis, Ottawa, CA /ID# 55296

Ottawa, Ontario, K2P 1V3, Canada

Location

Setty, Owen Sound, CA /ID# 54583

Owen Sound, Ontario, N4K 1S4, Canada

Location

Niagara Peninsula Arthritis Ct /ID# 67282

St. Catharines, Ontario, L2N 7E4, Canada

Location

Pedvis Med Prof Corp /ID# 55411

Toronto, Ontario, M4S 2C6, Canada

Location

Hamilton, Toronto, CA /ID# 54575

Toronto, Ontario, M4X 1W4, Canada

Location

Jonathan Stein Med Prof Corp /ID# 55451

Toronto, Ontario, M6S 4W4, Canada

Location

Karasik, Toronto, CA /ID# 54751

Toronto, Ontario, M9C 5N2, Canada

Location

Dr. Samuel K Silverberg /ID# 55449

Toronto, Ontario, M9V 4B8, Canada

Location

Ctr de Med Sportive de Laval /ID# 54576

Laval, Quebec, H7T 2Z8, Canada

Location

Institut de Rhum. de Montreal /ID# 54761

Montreal, Quebec, H2L 1S6, Canada

Location

Jewish General Hospital /ID# 63655

Montreal, Quebec, H3T 1E2, Canada

Location

PSS Medical Inc. /ID# 54754

Montreal, Quebec, H3T 1Y3, Canada

Location

Couture, Outremont, CA /ID# 54574

Outremont, Quebec, H2V 3Z5, Canada

Location

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

Rimouski, Quebec, G5L 8W1, Canada

Location

Clinique Medicale Langelier /ID# 55460

Saint-Léonard, Quebec, H1S 3A9, Canada

Location

Groupe de Recherche en Maladies Osseuses /ID# 45623

Sainte-Foy, Quebec, G1V 3M7, Canada

Location

Ctr. de Recherche Musculo-Sque /ID# 55469

Trois-Rivières, Quebec, G8Z 1Y2, Canada

Location

Rheum Disease Ctr of Montreal /ID# 143963

Westmount, Quebec, H3Z 2Z3, Canada

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

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: June 29, 2011
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: December 9, 2020

Record last verified: 2020-12

Locations

CA (56)