Behcet's DiseaseNCT03543709
Evaluation of Fibromyalgia With Disease Activity and Clinical Findings in Women With Behçet's Disease
An observational study of Behcet's Disease and Fibromyalgia, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In the literature, the relationship between fibromyalgia and disease activity has been assessed in a few studies without discrimination between women and men.In this study, it was aimed to evaluate the relationship between fibromyalgia and disease activity in women with Behçet's disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Behcet's Disease, Fibromyalgia
- What is being tested?
- fibromyalgia 2013 criteria and Behcet's disease current activity form
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jun 2018to 5 Feb 2019
- How long will I take part?
- 1 Day
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women diagnosed with Behcet disease according to international study group criteria, between age 18-75, which are not pregnant and which were not previously diagnosed with diabetes mellitus or chronic renal failure.
Who may be able to join
- Women diagnosed with Behcet disease according to international study group criteria
- Patients older than 18
- Patients younger than 75
Who cannot join
- Participants which were previously diagnosed with diabetes mellitus
- Participants which were previously diagnosed with chronic renal failure
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Fibromyalgia With Disease Activity and Clinical Findings in Women With Behçet's Disease in Province Bursa
In the literature, the relationship between fibromyalgia and disease activity has been assessed in a few studies without discrimination between women and men.In this study, it was aimed to evaluate the relationship between fibromyalgia and disease activity in women with Behçet's disease.
Read the detailed description
There are only a few studies in the literature evaluating the association of fibromyalgia with disease activity and clinical findings in Behçet's disease. In the literature, the relationship between fibromyalgia and disease activity has been assessed without discrimination between women and men. Behçet's disease is more active in men and fibromyalgia is more frequent in women. Evaluating the relationship between fibromyalgia and disease activity in Behçet's disease without gender discrimination may not be objective.There is not any study in literature evaluating relationship between fibromyalgia and disease activity in women with Behçet's disease.In this study, it was aimed to evaluate the relationship between fibromyalgia and disease activity in women with Behçet's disease.
- Conditions
- Behcet's Disease, Fibromyalgia
- Being tested
- fibromyalgia 2013 criteria, Behcet's disease current activity form
- Keywords
- Behcet's disease, Fibromyalgia, Disease activity
- Medical subject headings
- Behcet Syndrome, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fibromyalgia 2013 criteriaDiagnostic test
Frequency of fibromyalgia will be investigated in women diagnosed with Behcet disease
Behcet's disease current activity formOther
Disease activity will be investigated in women with Behçet's disease without fibromyalgia.
| Study group | Role | What they receive |
|---|---|---|
| Behcet and fibromyalgia | Women with Behcet's disease with fibromyalgia Receives: Diagnostic Test: fibromyalgia 2013 criteria; Other: Behcet's disease current activity form | |
| Behcet | Women with Behcet's disease without fibromyalgia Receives: Diagnostic Test: fibromyalgia 2013 criteria; Other: Behcet's disease current activity form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia 2013 criteria
Fibromyalgia 2013 criteria were derived from the 10-item symptom score from the Symptom Impact Questionnaire (SIQR) symptoms and the 28-area pain location inventory (PLI). If the patients PLI score is above 17 (range 0-28) and an SIQR symptom score is above 21 (range 0-50), the participant will be diagnosed with fibromyalgia
Measured: 5 months
Secondary outcomes (1)
Behcet's disease current activity form
Twelve items on the Behcet's disease current activity form, a potential unidimensional scale, will be used for the analysis as well as the two questions which assess disease activity from the patient's and clinician's perspective. These items are: a Likert scale, represented by 'smiley' faces ranging from very bad to very good, to indicate how the patient or the clinician felt the disease had been over the past 4 weeks, and the presence or absence (over the last 4 weeks prior to the clinic visit) of arthralgia, arthritis, diarrhoea, erythema nodosum, eye inflammation, genital ulcers, headaches, mouth ulcers, nausea/vomiting, new central nervous system involvement, new major vessel inflammation, and pustules.
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 posted1 Jun 2018
- Study start11 Jun 2018
- Primary completion5 Feb 2019
- Study completion5 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behcet's DiseaseStudies 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
- 72 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Koray Ayar, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543709
- Sponsor's protocol ID
- 2011-KAEK-26/105
- Status last verified
- Feb 2019
- First submitted
- 21 May 2018
- Last updated
- 6 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fibromyalgia With Disease Activity and Clinical Findings in Women With Behçet's Disease in Province Bursa
- ClinicalTrials.gov ID
- NCT03543709
- Acronym / sponsor ID
- 2011-KAEK-26/105
- Conditions
- Behcet's Disease, Fibromyalgia
- Keywords
- Behcet's disease, Fibromyalgia, Disease activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 5 Feb 2019 (actual)
- Study completion
- 5 Feb 2019 (actual)
- First posted
- 1 Jun 2018 (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.
In the literature, the relationship between fibromyalgia and disease activity has been assessed in a few studies without discrimination between women and men.In this study, it was aimed to evaluate the relationship between fibromyalgia and disease activity in women with Behçet's disease.
Detailed description
There are only a few studies in the literature evaluating the association of fibromyalgia with disease activity and clinical findings in Behçet's disease. In the literature, the relationship between fibromyalgia and disease activity has been assessed without discrimination between women and men. Behçet's disease is more active in men and fibromyalgia is more frequent in women. Evaluating the relationship between fibromyalgia and disease activity in Behçet's disease without gender discrimination may not be objective.There is not any study in literature evaluating relationship between fibromyalgia and disease activity in women with Behçet's disease.In this study, it was aimed to evaluate the relationship between fibromyalgia and disease activity in women with Behçet's disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behcet and fibromyalgia | – | Diagnostic Test: fibromyalgia 2013 criteria, Other: Behcet's disease current activity formWomen with Behcet's disease with fibromyalgia |
| Behcet | – | Diagnostic Test: fibromyalgia 2013 criteria, Other: Behcet's disease current activity formWomen with Behcet's disease without fibromyalgia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women diagnosed with Behcet disease according to international study group criteria, between age 18-75, which are not pregnant and which were not previously diagnosed with diabetes mellitus or chronic renal failure.
Key inclusion criteria (3 listed)
- Women diagnosed with Behcet disease according to international study group criteria
- Patients older than 18
- Patients younger than 75
Key exclusion criteria (3 listed)
- Participants which were previously diagnosed with diabetes mellitus
- Participants which were previously diagnosed with chronic renal failure
- Pregnant women
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 |
|---|---|---|
| fibromyalgia 2013 criteriaFrequency of fibromyalgia will be investigated in women diagnosed with Behcet disease | Diagnostic test | Behcet, Behcet and fibromyalgia |
| Behcet's disease current activity formDisease activity will be investigated in women with Behçet's disease without fibromyalgia. | Other | Behcet, Behcet and fibromyalgia |
Primary outcome
Fibromyalgia 2013 criteria
Time frame: 5 months
Fibromyalgia 2013 criteria were derived from the 10-item symptom score from the Symptom Impact Questionnaire (SIQR) symptoms and the 28-area pain location inventory (PLI). If the patients PLI score is above 17 (range 0-28) and an SIQR symptom score is above 21 (range 0-50), the participant will be diagnosed with fibromyalgia
1 secondary outcome
Behcet's disease current activity form
Time frame: 5 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 6 Feb 2019.
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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.
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 Behcet's Disease and Fibromyalgia, run by Bursa Yuksek Ihtisas 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 3 inclusion and 3 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 6 Feb 2019. 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?
Fibromyalgia 2013 criteria (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 6 Feb 2019.