Anti - TNF TherapyNCT04943237
Anti-TNF Therapy and Nerve Conduction Studies in Ankylosing Spondylitis
An observational study of Anti - TNF Therapy and Ankylosing Spondylitis, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Patients with ankylosing spondylitis were divided into 2 groups as anti-TNF and conventional therapy according to the treatments they were using for the last 5 years. Nerve conduction studies in the upper and lower extremities of the patients were compared. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Anti - TNF Therapy, Ankylosing Spondylitis, Neuropathy
- What is being tested?
- Anti-TNF agents and Conventional therapy users for the last 5 years
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 1 Oct 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had the diagnosis of ankylosing spondylitis and had used conventional or anti-TNF therapy at least 5 years.
Who may be able to join
- Patients diagnosed with ankylosing spondylitis
- Patients who have been using conventional therapy (non-steroidal anti-inflammatory drugs and/or salazopyrin) or anti-TNF therapy for more than 5 years.
Who cannot join
- Patients with rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus ......)
- Patients with other systemic diseases that can lead to neuropathy
- Patients who have had a known neuropathy or have taken medication that can lead to neuropathy as a side effect
- Patients with pacemakers
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine and Rehabilitation Training and research Hospital
Istanbul
About this study
Official title: Anti-TNF Therapy and Nerve Conduction Studies in Patients With Ankylosing Spondylitis
Patients with ankylosing spondylitis were divided into 2 groups as anti-TNF and conventional therapy according to the treatments they were using for the last 5 years. Nerve conduction studies in the upper and lower extremities of the patients were compared.
Read the detailed description
Demyelinating lesions in central nervous system after anti-TNF agents were reported previously. There are limited studies investigating the effects of anti-TNF treatments on the peripheral nervous system. The aim of this study is to investigate whether peripheral nerves are affected due to long-term use of anti-TNF agents.
Patients with a diagnosis of ankylosing spondylitis who received conventional or anti-TNF therapy for five years at Istanbul Physical Therapy and Rehabilitation Training and Research Hospital were included in the study. The patients were divided into two groups as conventional group and anti-TNF group according to the treatment they received. All patients were evaluated in a single section. Sociodemographic characteristics of the patients and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functionality Index (BASFI) and Bath Ankylosing Spondylitis Metrology Index (BASMI) scores were recorded. Median-ulnar motor and sensory conduction studies and tibial-peroneal motor and sural nerve sensory conduction studies were performed in both upper extremities of all patients. Median, ulnar, and tibial nerve F-response studies were also performed.
- Conditions
- Anti - TNF Therapy, Ankylosing Spondylitis, Neuropathy
- Being tested
- Anti-TNF agents, Conventional therapy users for the last 5 years
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-TNF agentsDrug
Also called Anti-TNF agents users for the last 5 years.
Group of patients using anti-TNF for the last 5 years.
Conventional therapy users for the last 5 yearsDrug
Also called Conventional therapy (non steroid anti inflammatory drugs and/or salazopyrin)
Group of patients not using anti-TNF. Group of patients using conventional therapy (non -steroid anti-inflammatory drugs and/or salazopyrin) for the last 5 years
What is being measured
The primary outcome is the main question the study is designed to answer.
nerve conduction studies
The evaluation of median, ulnar, tibial, peroneal and sural nerves
Measured: All patients were evaluated in one session. The assesment of a patient lasted nearly 45-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Jul 2019
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti - TNF TherapyStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Betül Yavuz Keleş, MD, Principal investigator, Istanbul physical Medicine and Rehabilitation Training and Research HospitalAyşe Nur Bardak, prof, Study director, Istanbul physical Medicine and Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943237
- Sponsor's protocol ID
- IstPMRTRHatncsias
- Status last verified
- Jun 2021
- First submitted
- 19 Jun 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-TNF Therapy and Nerve Conduction Studies in Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT04943237
- Acronym / sponsor ID
- IstPMRTRHatncsias
- Conditions
- Anti - TNF Therapy, Ankylosing Spondylitis, Neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 29 Jun 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.
Patients with ankylosing spondylitis were divided into 2 groups as anti-TNF and conventional therapy according to the treatments they were using for the last 5 years. Nerve conduction studies in the upper and lower extremities of the patients were compared.
Detailed description
Demyelinating lesions in central nervous system after anti-TNF agents were reported previously. There are limited studies investigating the effects of anti-TNF treatments on the peripheral nervous system. The aim of this study is to investigate whether peripheral nerves are affected due to long-term use of anti-TNF agents.
Patients with a diagnosis of ankylosing spondylitis who received conventional or anti-TNF therapy for five years at Istanbul Physical Therapy and Rehabilitation Training and Research Hospital were included in the study. The patients were divided into two groups as conventional group and anti-TNF group according to the treatment they received. All patients were evaluated in a single section. Sociodemographic characteristics of the patients and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functionality Index (BASFI) and Bath Ankylosing Spondylitis Metrology Index (BASMI) scores were recorded. Median-ulnar motor and sensory conduction studies and tibial-peroneal motor and sural nerve sensory conduction studies were performed in both upper extremities of all patients. Median, ulnar, and tibial nerve F-response studies were also performed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had the diagnosis of ankylosing spondylitis and had used conventional or anti-TNF therapy at least 5 years.
Key inclusion criteria (2 listed)
- Patients diagnosed with ankylosing spondylitis
- Patients who have been using conventional therapy (non-steroidal anti-inflammatory drugs and/or salazopyrin) or anti-TNF therapy for more than 5 years.
Key exclusion criteria (4 listed)
- Patients with rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus ......)
- Patients with other systemic diseases that can lead to neuropathy
- Patients who have had a known neuropathy or have taken medication that can lead to neuropathy as a side effect
- Patients with pacemakers
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 |
|---|---|---|
| Anti-TNF agentsAlso: Anti-TNF agents users for the last 5 years.Group of patients using anti-TNF for the last 5 years. | Drug | – |
| Conventional therapy users for the last 5 yearsAlso: Conventional therapy (non steroid anti inflammatory drugs and/or salazopyrin)Group of patients not using anti-TNF. Group of patients using conventional therapy (non -steroid anti-inflammatory drugs and/or salazopyrin) for the last 5 years | Drug | – |
Primary outcome
nerve conduction studies
Time frame: All patients were evaluated in one session. The assesment of a patient lasted nearly 45-60 minutes
The evaluation of median, ulnar, tibial, peroneal and sural nerves
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 29 Jun 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.
Betül Yavuz Keleş, MD principal investigator
Istanbul physical Medicine and Rehabilitation Training and Research Hospital
Ayşe Nur Bardak, prof study director
Istanbul physical Medicine and Rehabilitation Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anti - TNF Therapy and Ankylosing Spondylitis, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 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 29 Jun 2021. 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 Turkey (Türkiye). 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?
nerve conduction studies (time frame: All patients were evaluated in one session. The assesment of a patient lasted nearly 45-60 minutes). 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 29 Jun 2021.