Ankylosing SpondylitisNCT04746196
Galectin-3 Level in Ankylosing Spondylitis Patients
An observational study of Ankylosing Spondylitis, run by Recep Tayyip Erdogan University Training and Research Hospital.
Trial summary
Forty-five AS patients and 35 healthy controls were enrolled in this study. Patients diagnosed with AS according to Modified New York criteria were included in the study. Clinical and laboratory measurements, duration of symptoms, age and body mass index (BMI) of AS patients were performed and compared with age and… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Serum galectin-3 concentration was measured.
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 30 Aug 2017
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ankylosing spondylitis patients and healthy controls
Who may be able to join
- Ankylosing spondylitis patients
- Healthy controls
Who cannot join
- Hyperlipidemia
- Liver diseases
- Renal diseases
- Hematological diseases
- Familial thyroid diseases
- Neoplastic diseases
- Autoimmune infectious diseases
- Receiving anti-inflammatory drugs.
About this study
Official title: Relationship Between Galectin-3 Level and Disease Activity in Ankylosing Spondylitis Patients
Forty-five AS patients and 35 healthy controls were enrolled in this study. Patients diagnosed with AS according to Modified New York criteria were included in the study. Clinical and laboratory measurements, duration of symptoms, age and body mass index (BMI) of AS patients were performed and compared with age and BMI matched control group.
Read the detailed description
Detailed histories of all participants were obtained, and systemic and rheumatologic examinations were performed. We excluded all participants who had a history of hyperlipidemia, liver, renal, hematological, familial thyroid, neoplastic, autoimmune infectious diseases and receiving anti-inflammatory drugs.
We measured serum galectin-3 levels using a commercial chemiluminescent microparticle immunoassay. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was used to assess disease activity in AS patients.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Serum galectin-3 concentration was measured.
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum galectin-3 concentration was measured.Other
Serum galectin-3 concentration was measured using a commercial chemiluminescent microparticle immunoassay.
| Study group | Role | What they receive |
|---|---|---|
| 45 ankylosing spondylitis patients. | Patients diagnosed with ankylosing spondylitis according to Modified New York criteria were included in the study. Receives: Other: Serum galectin-3 concentration was measured. | |
| 35 controls | Healthy controls Receives: Other: Serum galectin-3 concentration was measured. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship Between Galectin-3 Level and Disease Activity in Ankylosing Spondylitis Patients
Correlation
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Jan 2017
- Primary completion30 Jun 2017
- Study completion30 Aug 2017
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
- Other
- Time perspective
- Other
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gul Devrimsel, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746196
- Sponsor's protocol ID
- 2016/85
- Status last verified
- Apr 2021
- First submitted
- 4 Feb 2021
- Last updated
- 20 Apr 2021
- 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 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Galectin-3 Level and Disease Activity in Ankylosing Spondylitis Patients
- ClinicalTrials.gov ID
- NCT04746196
- Acronym / sponsor ID
- 2016/85
- Conditions
- Ankylosing Spondylitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 9 Feb 2021 (actual)
- 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.
Forty-five AS patients and 35 healthy controls were enrolled in this study. Patients diagnosed with AS according to Modified New York criteria were included in the study. Clinical and laboratory measurements, duration of symptoms, age and body mass index (BMI) of AS patients were performed and compared with age and BMI matched control group.
Detailed description
Detailed histories of all participants were obtained, and systemic and rheumatologic examinations were performed. We excluded all participants who had a history of hyperlipidemia, liver, renal, hematological, familial thyroid, neoplastic, autoimmune infectious diseases and receiving anti-inflammatory drugs.
We measured serum galectin-3 levels using a commercial chemiluminescent microparticle immunoassay. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was used to assess disease activity in AS patients.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 45 ankylosing spondylitis patients. | – | Other: Serum galectin-3 concentration was measured.Patients diagnosed with ankylosing spondylitis according to Modified New York criteria were included in the study. |
| 35 controls | – | Other: Serum galectin-3 concentration was measured.Healthy controls |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ankylosing spondylitis patients and healthy controls
Key inclusion criteria (2 listed)
- Ankylosing spondylitis patients
- Healthy controls
Key exclusion criteria (8 listed)
- Hyperlipidemia
- Liver diseases
- Renal diseases
- Hematological diseases
- Familial thyroid diseases
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 |
|---|---|---|
| Serum galectin-3 concentration was measured.Serum galectin-3 concentration was measured using a commercial chemiluminescent microparticle immunoassay. | Other | 35 controls, 45 ankylosing spondylitis patients. |
Primary outcome
Relationship Between Galectin-3 Level and Disease Activity in Ankylosing Spondylitis Patients
Time frame: 5 months
Correlation
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 20 Apr 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Ankylosing Spondylitis
RecruitingPhase 1
Phase Ia Study of MST-931 in Healthy Adult Subjects
Ankylosing Spondylitis (AS)
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Not yet recruitingObservational study
SLAMF1 Gene Expression in Ankylosing Spondylitis
Ankylosing Spondylitis
RecruitingObservational study
Natural History and Development of Spondyloarthritis
Arthritis, Spondylitis, Ankylosing
Not yet recruitingPhase 4
Ivarmacitinib With or Without Celecoxib for Ankylosing Spondylitis
Ankylosing Spondylitis (AS)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis, run by Recep Tayyip Erdogan University Training and Research Hospital.
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 2 inclusion and 8 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 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Relationship Between Galectin-3 Level and Disease Activity in Ankylosing Spondylitis Patients (time frame: 5 months). 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 20 Apr 2021.