SpondyloarthritisPhase 4NCT04953871
Enthesitis Assessment Before and After Anti-Tumor Necrosis Factor Treatment in Spondyloarthritis
A Phase 4 study testing TNF Inhibitor in people with Spondyloarthritis and Enthesitis, run by Gunay ER.
Trial summary
Biological therapies should be considered in patients with high disease activity despite nonsteroid antiinflammatory drug treatment. The first option among biological therapies is anti-Tumor Necrosis Factor (anti-TNF) drugs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spondyloarthritis, Enthesitis, Anti-Tumor Necrosis Factor Drugs
- What is being tested?
- TNF Inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2018
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spondyloarthritis patients were diagnosed according to 2009 Assessment of Spondyloarthritis International Society (ASAS) criteria
Who cannot join
- Severe cardiovascular and respiratory diseases,
- Severe liver and kidney failure,
- Pregnancy and lactation,
- Active infection,
- Malignancy,
- Demyelinating diseases,
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- Systemic lupus erythematosus,
- History of knee, elbow, foot and ankle surgery,
- Fluoroquinolone, retinoid and fluoride use,
- Local corticosteroid injection at the examination sites within the six weeks before evaluation
- Peripheral neuropathy
About this study
Official title: Clinical and Ultrasonographic Enthesitis Assessment Before and After Anti-Tumor Necrosis Factor Treatment in Patients With Spondyloarthritis
Biological therapies should be considered in patients with high disease activity despite nonsteroid antiinflammatory drug treatment. The first option among biological therapies is anti-Tumor Necrosis Factor (anti-TNF) drugs. In recent years, anti-TNF treatments have shown that clinical and ultrasonographic enthesitis may improve as well as disease activity, quality of life and acute phase reactants. In this prospective study, we aimed to evaluate the clinical and ultrasonographic evaluation of enthesitis and to determine its response to anti-TNF treatment in patients with SpA.In this prospective study, we aimed to evaluate the clinical and ultrasonographic evaluation of enthesitis and to determine its response to anti-TNF treatment in patients with SpA.
- Being tested
- TNF Inhibitor
- Medical subject headings
- Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNF InhibitorDrug
TNF inhibitors are widely used in patients with spondyloarthritis
| Study group | Role | What they receive |
|---|---|---|
| Spondyloarthritis | Experimental | Spondyloarthritis patients who was initiated TNF alfa blocker Receives: Drug: TNF Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from ultrasonographic entesitis score at 3 months
Madrid Sonographic Enthesitis Index was used to screen etheseal sites
Measured: before and 3 months after anti-TNF treatment
Secondary outcomes (4)
Change from disease activity
Bath Ankylosing Spondylitis Disease Activity Index was used
Measured: before and 3 months after anti-TNF treatment
Change from disease activity
Ankylosing Spondylitis Disease Activity Score was used
Measured: before and 3 months after anti-TNF treatment
Change from quality of life
Ankylosing Spondylitis Quality of Life was used
Measured: before and 3 months after anti-TNF treatment
Change from Functionality
Bath Ankylosing Spondylitis Functionality Index was used
Measured: before and 3 months after anti-TNF treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study startJan 2017
- Primary completionSep 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthritisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gunay ER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gunay ER, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953871
- Sponsor's protocol ID
- 89403766-604.01.02-147611
- Status last verified
- Jul 2021
- First submitted
- 22 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Ultrasonographic Enthesitis Assessment Before and After Anti-Tumor Necrosis Factor Treatment in Patients With Spondyloarthritis
- ClinicalTrials.gov ID
- NCT04953871
- Acronym / sponsor ID
- 89403766-604.01.02-147611
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Gunay ERUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 8 Jul 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.
Biological therapies should be considered in patients with high disease activity despite nonsteroid antiinflammatory drug treatment. The first option among biological therapies is anti-Tumor Necrosis Factor (anti-TNF) drugs. In recent years, anti-TNF treatments have shown that clinical and ultrasonographic enthesitis may improve as well as disease activity, quality of life and acute phase reactants. In this prospective study, we aimed to evaluate the clinical and ultrasonographic evaluation of enthesitis and to determine its response to anti-TNF treatment in patients with SpA.In this prospective study, we aimed to evaluate the clinical and ultrasonographic evaluation of enthesitis and to determine its response to anti-TNF treatment in patients with SpA.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spondyloarthritis | Experimental | Drug: TNF InhibitorSpondyloarthritis patients who was initiated TNF alfa blocker |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Spondyloarthritis patients were diagnosed according to 2009 Assessment of Spondyloarthritis International Society (ASAS) criteria
Key exclusion criteria (11 listed)
- Severe cardiovascular and respiratory diseases,
- Severe liver and kidney failure,
- Pregnancy and lactation,
- Active infection,
- Malignancy,
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 |
|---|---|---|
| TNF InhibitorTNF inhibitors are widely used in patients with spondyloarthritis | Drug | Spondyloarthritis |
Primary outcome
change from ultrasonographic entesitis score at 3 months
Time frame: before and 3 months after anti-TNF treatment
Madrid Sonographic Enthesitis Index was used to screen etheseal sites
4 secondary outcomes
Change from disease activity
Time frame: before and 3 months after anti-TNF treatment
Change from disease activity
Time frame: before and 3 months after anti-TNF treatment
Change from quality of life
Time frame: before and 3 months after anti-TNF treatment
Change from Functionality
Time frame: before and 3 months after anti-TNF treatment
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 8 Jul 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TNF Inhibitor in people with Spondyloarthritis and Enthesitis, run by Gunay ER.
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 1 inclusion and 11 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 8 Jul 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
change from ultrasonographic entesitis score at 3 months (time frame: before and 3 months after anti-TNF treatment). 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 8 Jul 2021.