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

Ankylosing Spondylitis Clinical Trial

— Complete-AS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01387802
• Other study ID #: P12-672
• Status: Completed
• Start date: June 29, 2011
• Est. completion date: December 16, 2019

Study information

• Verified date: December 2020
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 722
• Est. completion date: December 16, 2019
• Est. primary completion date: December 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Locations

Country	Name	City	State
Canada	Pavlova, Hamilton, CA /ID# 65011	Ancaster	Ontario
Canada	Waterside Clinique /ID# 72174	Barrie	Ontario
Canada	Joshi, Brampton, Canada /ID# 54758	Brampton	Ontario
Canada	Brockville Medical Center /ID# 65502	Brockville	Ontario
Canada	Aviva Clinical Trial Group /ID# 54764	Burlington	Ontario
Canada	Dr. Sanjay Dixit Medicine Professional Corporation /ID# 67347	Burlington	Ontario
Canada	Associate Clinic /ID# 64274	Calgary	Alberta
Canada	Rheumatology Clinic /ID# 54768	Calgary	Alberta
Canada	Pont, Cranbrook, BC, CA /ID# 55242	Cranbrook	British Columbia
Canada	Dr. Chrisotomor Kouroukis & Dr /ID# 137831	Dundas	Ontario
Canada	Bulleid Henderson Prof. Corp. /ID# 55256	Fredericton	New Brunswick
Canada	Ecker, Fredericton, CA /ID# 54748	Fredericton	New Brunswick
Canada	Qe Ii Hsc /Id# 55261	Halifax	Nova Scotia
Canada	Charlton Medical Centre /ID# 133072	Hamilton	Ontario
Canada	Charlton Medical Centre /ID# 55417	Hamilton	Ontario
Canada	Dr. William G. Bensen Centre /ID# 54762	Hamilton	Ontario
Canada	West Mountain Medical Center /ID# 128877	Hamilton	Ontario
Canada	Dr. Barbara T. Blumenauer Inc. /ID# 55226	Kamloops	British Columbia
Canada	Hudson, Kamloops, Canada /ID# 54577	Kamloops	British Columbia
Canada	KW Musculoskeletal Research /ID# 70093	Kitchener	Ontario
Canada	Ctr de Med Sportive de Laval /ID# 54576	Laval	Quebec
Canada	Brandusa Florica Med Prof Corp /ID# 81877	Mississauga	Ontario
Canada	Credit Valley Rheumatology /ID# 54750	Mississauga	Ontario
Canada	Imtiaz MS Khan Medicine Prof /ID# 55401	Mississauga	Ontario
Canada	Montgomery, Mississauga, CA /ID# 54581	Mississauga	Ontario
Canada	Institut de Rhum. de Montreal /ID# 54761	Montreal	Quebec
Canada	Jewish General Hospital /ID# 63655	Montreal	Quebec
Canada	PSS Medical Inc. /ID# 54754	Montreal	Quebec
Canada	Dr. Maqbool R. Sheriff Inc. /ID# 55247	Nanaimo	British Columbia
Canada	Morassut, Nepean, Canada /ID# 55410	Nepean	Ontario
Canada	The Arthritis Program Res Grp /ID# 54755	Newmarket	Ontario
Canada	Rajwinder S. Dhillon Medicine /ID# 138671	Niagara Falls	Ontario
Canada	Davis, Ottawa, CA /ID# 55296	Ottawa	Ontario
Canada	Kapur, Ottawa, Canada /ID# 55397	Ottawa	Ontario
Canada	Couture, Outremont, CA /ID# 54574	Outremont	Quebec
Canada	Setty, Owen Sound, CA /ID# 54583	Owen Sound	Ontario
Canada	Stewart, Penticton, CA /ID# 67096	Penticton	British Columbia
Canada	Dr. Michael Buchanan, Inc. /ID# 55227	Prince George	British Columbia
Canada	Dr. J. Antonio Avina-Zubieta /ID# 68263	Richmond	British Columbia
Canada	Ctr. de Rheum de l'est du QC /ID# 54765	Rimouski	Quebec
Canada	Clinique Medicale Langelier /ID# 55460	Saint-leonard	Quebec
Canada	Groupe de Recherche en Maladies Osseuses /ID# 45623	Sainte-foy	Quebec
Canada	Niagara Peninsula Arthritis Ct /ID# 67282	St. Catharines	Ontario
Canada	Nexus Clinical Research /ID# 54757	St. John's	Newfoundland and Labrador
Canada	St. Clare's Mercy Hospital /ID# 54767	St. John's	Newfoundland and Labrador
Canada	Dr. Juris Lazovskis Inc. /ID# 61562	Sydney	Nova Scotia
Canada	Dr. Samuel K Silverberg /ID# 55449	Toronto	Ontario
Canada	Hamilton, Toronto, CA /ID# 54575	Toronto	Ontario
Canada	Jonathan Stein Med Prof Corp /ID# 55451	Toronto	Ontario
Canada	Karasik, Toronto, CA /ID# 54751	Toronto	Ontario
Canada	Pedvis Med Prof Corp /ID# 55411	Toronto	Ontario
Canada	Ctr. de Recherche Musculo-Sque /ID# 55469	Trois-rivières	Quebec
Canada	Dr. Alfonso Verdejo Inc. /ID# 54572	Vancouver	British Columbia
Canada	Dr. Milton F. Baker Inc. /ID# 55197	Victoria	British Columbia
Canada	Rheum Disease Ctr of Montreal /ID# 143963	Westmount	Quebec
Canada	Manitoba Clinic /ID# 54580	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)	Cato Research, JSS Medical Research Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	BASFI (Bath AS Functional Assay)	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
Secondary	PASQ (Psoriasis and Arthritis Screening Questionnaire)	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
Secondary	BASDAI (Bath AS Disease Activity Index)	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

External Links

•   clinical study report synopsis