Ankylosing SpondylitisComplete-ASNCT01387802
Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Ankylosing Spondylitis
An observational study of Ankylosing Spondylitis, run by AbbVie (prior sponsor, Abbott) at 56 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Ankylosing Spondylitis
- How many people
- 722 participants
- Where
- 56 sitesCanada
- Study dates
- 29 Jun 2011to 16 Dec 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
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 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
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-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
Trial locations and contacts
56 sites in 1 country.
56 sites in 1 country
Canada56 sites
Pavlova, Hamilton, CA /ID# 65011
Ancaster, Ontario, L9G 3K9
Waterside Clinique /ID# 72174
Barrie, Ontario, L4M 6L2
Joshi, Brampton, Canada /ID# 54758
Brampton, Ontario, L6T 3J1
Brockville Medical Center /ID# 65502
Brockville, Ontario, K6V 5J9
Dr. Sanjay Dixit Medicine Professional Corporation /ID# 67347
Burlington, Ontario, L7L 0B7
Aviva Clinical Trial Group /ID# 54764
Burlington, Ontario, L7R 1E2
Rheumatology Clinic /ID# 54768
Calgary, Alberta, T2P 0V2
Associate Clinic /ID# 64274
Calgary, Alberta, T2P 3C5
Pont, Cranbrook, BC, CA /ID# 55242
Cranbrook, British Columbia, V1C 2R7
Dr. Chrisotomor Kouroukis & Dr /ID# 137831
Dundas, Ontario, L9H 1B7
Bulleid Henderson Prof. Corp. /ID# 55256
Fredericton, New Brunswick, E3B 6H5
Ecker, Fredericton, CA /ID# 54748
Fredericton, New Brunswick, E3B 6H5
Qe Ii Hsc /Id# 55261
Halifax, Nova Scotia, B3H 1V7
Charlton Medical Centre /ID# 133072
Hamilton, Ontario, L8N 1Y2
Charlton Medical Centre /ID# 55417
Hamilton, Ontario, L8N 1Y2
Dr. William G. Bensen Centre /ID# 54762
Hamilton, Ontario, L8N 1Y2
West Mountain Medical Center /ID# 128877
Hamilton, Ontario, L9C 5N2
Dr. Barbara T. Blumenauer Inc. /ID# 55226
Kamloops, British Columbia, V2C 0B8
Hudson, Kamloops, Canada /ID# 54577
Kamloops, British Columbia, V2C 6G6
KW Musculoskeletal Research /ID# 70093
Kitchener, Ontario, N2M 5N6
Ctr de Med Sportive de Laval /ID# 54576
Laval, Quebec, H7T 2Z8
Brandusa Florica Med Prof Corp /ID# 81877
Mississauga, Ontario, L5A 3V8
Montgomery, Mississauga, CA /ID# 54581
Mississauga, Ontario, L5A 3V8
Credit Valley Rheumatology /ID# 54750
Mississauga, Ontario, L5M 2V8
Imtiaz MS Khan Medicine Prof /ID# 55401
Mississauga, Ontario, L5M 4N4
Institut de Rhum. de Montreal /ID# 54761
Montreal, Quebec, H2L 1S6
Jewish General Hospital /ID# 63655
Montreal, Quebec, H3T 1E2
PSS Medical Inc. /ID# 54754
Montreal, Quebec, H3T 1Y3
Dr. Maqbool R. Sheriff Inc. /ID# 55247
Nanaimo, British Columbia, V9S 4S1
Morassut, Nepean, Canada /ID# 55410
Nepean, Ontario, K2G 6E2
The Arthritis Program Res Grp /ID# 54755
Newmarket, Ontario, L3Y 3R7
Rajwinder S. Dhillon Medicine /ID# 138671
Niagara Falls, Ontario, L2E 6A6
Kapur, Ottawa, Canada /ID# 55397
Ottawa, Ontario, K2A 3Z3
Davis, Ottawa, CA /ID# 55296
Ottawa, Ontario, K2P 1V3
Couture, Outremont, CA /ID# 54574
Outremont, Quebec, H2V 3Z5
Setty, Owen Sound, CA /ID# 54583
Owen Sound, Ontario, N4K 1S4
Stewart, Penticton, CA /ID# 67096
Penticton, British Columbia, V2A 3G7
Dr. Michael Buchanan, Inc. /ID# 55227
Prince George, British Columbia, V2L 5R6
Dr. J. Antonio Avina-Zubieta /ID# 68263
Richmond, British Columbia, V6X 2C7
Ctr. de Rheum de l'est du QC /ID# 54765
Rimouski, Quebec, G5L 8W1
Clinique Medicale Langelier /ID# 55460
Saint-Léonard, Quebec, H1S 3A9
Groupe de Recherche en Maladies Osseuses /ID# 45623
Sainte-Foy, Quebec, G1V 3M7
Niagara Peninsula Arthritis Ct /ID# 67282
St. Catharines, Ontario, L2N 7E4
Nexus Clinical Research /ID# 54757
St. John's, Newfoundland and Labrador, A1B 5E8
St. Clare's Mercy Hospital /ID# 54767
St. John's, Newfoundland and Labrador, A1C 5B8
Dr. Juris Lazovskis Inc. /ID# 61562
Sydney, Nova Scotia, B1S 3N1
Pedvis Med Prof Corp /ID# 55411
Toronto, Ontario, M4S 2C6
Hamilton, Toronto, CA /ID# 54575
Toronto, Ontario, M4X 1W4
Jonathan Stein Med Prof Corp /ID# 55451
Toronto, Ontario, M6S 4W4
Karasik, Toronto, CA /ID# 54751
Toronto, Ontario, M9C 5N2
Dr. Samuel K Silverberg /ID# 55449
Toronto, Ontario, M9V 4B8
Ctr. de Recherche Musculo-Sque /ID# 55469
Trois-Rivières, Quebec, G8Z 1Y2
Dr. Alfonso Verdejo Inc. /ID# 54572
Vancouver, British Columbia, V6Z 2E8
Dr. Milton F. Baker Inc. /ID# 55197
Victoria, British Columbia, V8P 5P6
Rheum Disease Ctr of Montreal /ID# 143963
Westmount, Quebec, H3Z 2Z3
Manitoba Clinic /ID# 54580
Winnipeg, Manitoba, R3A IM3
About this study
Official title: 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.
- Conditions
- Ankylosing Spondylitis
- Keywords
- Assessing Effectiveness in Ankylosing Spondylitis
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: 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))
Measured: 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))
Measured: 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))
Measured: Every 3 months up to 6 months, then every 6 months up to 24 months
Secondary outcomes (3)
BASFI (Bath AS Functional Assay)
This is a 100 VAS with 0 indicating lowest functional limitations and 10 highest functional limitations
Measured: Every 3 months up to 6 months, then every 6 months up to 24 months
PASQ (Psoriasis and Arthritis Screening Questionnaire)
This is an 11 item tool that ascertains self reported presence of joint pain and swelling.
Measured: Every 3 months up to 6 months, then every 6 months up to 24 months
BASDAI (Bath AS Disease Activity Index)
This is a 100 VAS with 0 indicating lowest disease activity and 10 highest disease activity
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.
- First posted6 Jul 2011 (estimated)
- Study start29 Jun 2011
- Primary completion16 Dec 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 722 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- JSS Medical Research Inc., Cato Research
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387802
- Sponsor's protocol ID
- P12-672
- Acronym
- Complete-AS
- Status last verified
- Dec 2020
- First submitted
- 1 Jul 2011
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Ankylosing Spondylitis (Complete - AS)
- ClinicalTrials.gov ID
- NCT01387802
- Acronym / sponsor ID
- Complete-AS / P12-672
- Conditions
- Ankylosing Spondylitis
- Keywords
- Assessing Effectiveness in Ankylosing Spondylitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 722 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Collaborators
- JSS Medical Research Inc., Cato Research
- Study start
- 29 Jun 2011 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 6 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Offices of community rheumatologists
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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))
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))
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))
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))
3 secondary outcomes
BASFI (Bath AS Functional Assay)
Time frame: 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
BASDAI (Bath AS Disease Activity Index)
Time frame: Every 3 months up to 6 months, then every 6 months up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- clinical study report synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
56 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis, run by AbbVie (prior sponsor, Abbott) at 56 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 5 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 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 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?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2020.