Ankylosing SpondylarthritisASAANCT02809300
Ankylosing Spondylitis and Antiphospholipid Antibodies
A study testing blood collection in people with Ankylosing Spondylarthritis, run by CHU de Reims at 1 site in France.
Trial summary
The main objective is to evaluate the prevalence of anti-phospholipid antibodies (APLA) in patients with ankylosing spondylitis (AS). The secondary objectives are: (1) To determine whether the presence of these antibodies is symptomatic (thrombosis or not); (2) Identify a possible relationship between the presence of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylarthritis
- What is being tested?
- blood collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Mar 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older than 18 years
- with SA according to ASAS criteria
- followed in the Internal Medicine Department of the REIMS University Hospital
- who have given their consent
- affiliated to social security insurance
Who cannot join
- minor patients
- patients with autoimmune disease (except the inflammatory bowel disease)
- cancer
- coagulation disorders
- anticoagulant treatment (anticoagulation out for events history thrombus embolism)
- pregnant women
- patients protected by law
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Reims
France, Reims, 51092
Damien JOLLY, 326788472 ext. 33, djolly@chu-reims.fr
About this study
Official title: Prevalence of Antiphospholipid Antibodies in Ankylosing Spondylitis: A Study of 80 Patients
The main objective is to evaluate the prevalence of anti-phospholipid antibodies (APLA) in patients with ankylosing spondylitis (AS).
The secondary objectives are: (1) To determine whether the presence of these antibodies is symptomatic (thrombosis or not); (2) Identify a possible relationship between the presence of APLA and a particular form of SA (axial or peripheral); (3) To determine whether the presence of APLA is more frequent in patients receiving anti-tumor necrosis factor (TNF) alpha therapy.
Read the detailed description
Methods:
Experimental design: longitudinal study prospective in a single center.
The Ankylosing Spondylitis Assesment Study (ASAS) criteria are: (1) age <45 years, back pain ≥ 3 months, sacroiliitis on imaging and ≥ 1 associated minor criterion, or (2) HLA B27 positive and ≥ 2 minor criteria.
Minor criteria are: inflammatory back pain, arthritis, enthesitis, uveitis, Dactylitis, psoriasis, Crohn's disease, good clinical response to NSAIDs, family history of Human Leukocyte Antigen HLA B27 and inflammatory syndrome.
Plan Investigation:
Patients in the study will be seen first in consultation to gather the necessary information: history taking (including venous and arterial embolic events and obstetric history), the usual treatment, ASAS criteria of therapeutic AS, current and previous, comprehensive physical examination.
APLA will be measured at baseline and at least 3 months if initially positive.
OUTCOME:
The primary endpoint is the presence or absence of APLA: anti-cardiolipin antibodies (CLA) immunoglobulin M (IgM) or immunoglobulin G (IgG), circulating anticoagulant lupus (CCA), anti-beta2 glycoprotéine1 antibodies (β2GP1A) IgM or IgG.
The secondary endpoints are:
- The presence of thrombosis (past or present) or obstetrical accident (anterior)
- Relationship between the presence of APLA and a particular form of AS (axial or peripheral)
- Relationship between the presence of APLA and anti-TNF alpha therapy
Calendar:
The expected study duration is 16 months.
Statistical Analysis Plan A descriptive analysis will be performed. The variables are described by their number and percentage; quantitative variables are described by their mean and standard deviation. A calculation of the prevalence of APLA will be made. Univariate analysis will be performed for the secondary objectives by the Chi 2 test or Fisher exact test according to the application conditions.
- Conditions
- Ankylosing Spondylarthritis
- Being tested
- blood collection
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood collectionBiological
| Study group | Role | What they receive |
|---|---|---|
| ankylosing spondylarthritis | Experimental | Not described Receives: Biological: blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence or absence of APLA
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startNov 2015
- Primary completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylarthritisStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809300
- Sponsor's protocol ID
- PA15075
- Acronym
- ASAA
- Status last verified
- Jun 2016
- First submitted
- 20 Jun 2016
- Last updated
- 23 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Antiphospholipid Antibodies in Ankylosing Spondylitis: A Study of 80 Patients
- ClinicalTrials.gov ID
- NCT02809300
- Acronym / sponsor ID
- ASAA / PA15075
- Conditions
- Ankylosing Spondylarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Mar 2017 (estimated)
- First posted
- 22 Jun 2016 (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 main objective is to evaluate the prevalence of anti-phospholipid antibodies (APLA) in patients with ankylosing spondylitis (AS).
The secondary objectives are: (1) To determine whether the presence of these antibodies is symptomatic (thrombosis or not); (2) Identify a possible relationship between the presence of APLA and a particular form of SA (axial or peripheral); (3) To determine whether the presence of APLA is more frequent in patients receiving anti-tumor necrosis factor (TNF) alpha therapy.
Detailed description
Methods:
Experimental design: longitudinal study prospective in a single center.
The Ankylosing Spondylitis Assesment Study (ASAS) criteria are: (1) age <45 years, back pain ≥ 3 months, sacroiliitis on imaging and ≥ 1 associated minor criterion, or (2) HLA B27 positive and ≥ 2 minor criteria.
Minor criteria are: inflammatory back pain, arthritis, enthesitis, uveitis, Dactylitis, psoriasis, Crohn's disease, good clinical response to NSAIDs, family history of Human Leukocyte Antigen HLA B27 and inflammatory syndrome.
Plan Investigation:
Patients in the study will be seen first in consultation to gather the necessary information: history taking (including venous and arterial embolic events and obstetric history), the usual treatment, ASAS criteria of therapeutic AS, current and previous, comprehensive physical examination.
APLA will be measured at baseline and at least 3 months if initially positive.
OUTCOME:
The primary endpoint is the presence or absence of APLA: anti-cardiolipin antibodies (CLA) immunoglobulin M (IgM) or immunoglobulin G (IgG), circulating anticoagulant lupus (CCA), anti-beta2 glycoprotéine1 antibodies (β2GP1A) IgM or IgG.
The secondary endpoints are:
- The presence of thrombosis (past or present) or obstetrical accident (anterior)
- Relationship between the presence of APLA and a particular form of AS (axial or peripheral)
- Relationship between the presence of APLA and anti-TNF alpha therapy
Calendar:
The expected study duration is 16 months.
Statistical Analysis Plan A descriptive analysis will be performed. The variables are described by their number and percentage; quantitative variables are described by their mean and standard deviation. A calculation of the prevalence of APLA will be made. Univariate analysis will be performed for the secondary objectives by the Chi 2 test or Fisher exact test according to the application conditions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ankylosing spondylarthritis | Experimental | Biological: blood collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- older than 18 years
- with SA according to ASAS criteria
- followed in the Internal Medicine Department of the REIMS University Hospital
- who have given their consent
- affiliated to social security insurance
Key exclusion criteria (7 listed)
- minor patients
- patients with autoimmune disease (except the inflammatory bowel disease)
- cancer
- coagulation disorders
- anticoagulant treatment (anticoagulation out for events history thrombus embolism)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood collection | Biological | ankylosing spondylarthritis |
Primary outcome
presence or absence of APLA
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood collection in people with Ankylosing Spondylarthritis, run by CHU de Reims at 1 site in France.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pauline ORQUEVAUD (326832465 ext. 33, porquevaux@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence or absence of APLA (time frame: 12 weeks). 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 23 Jun 2016.