NCT03543709

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

June 11, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2019

Completed
Last Updated

February 6, 2019

Status Verified

February 1, 2019

Enrollment Period

8 months

First QC Date

May 21, 2018

Last Update Submit

February 5, 2019

Conditions

Behcet's DiseaseFibromyalgia

Keywords

Behcet's diseaseFibromyalgiaDisease activity

Outcome Measures

Primary Outcomes (1)

  • 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

    5 months

Secondary Outcomes (1)

  • Behcet's disease current activity form

    5 months

Study Arms (2)

Behcet and fibromyalgia

Women with Behcet's disease with fibromyalgia

Diagnostic Test: fibromyalgia 2013 criteriaOther: Behcet's disease current activity form

Behcet

Women with Behcet's disease without fibromyalgia

Diagnostic Test: fibromyalgia 2013 criteriaOther: Behcet's disease current activity form

Interventions

fibromyalgia 2013 criteriaDIAGNOSTIC_TEST

Frequency of fibromyalgia will be investigated in women diagnosed with Behcet disease

BehcetBehcet and fibromyalgia
Behcet's disease current activity formOTHER

Disease activity will be investigated in women with Behçet's disease without fibromyalgia.

BehcetBehcet and fibromyalgia

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Women diagnosed with Behcet disease according to international study group criteria
  • Patients older than 18
  • Patients younger than 75

You may not qualify if:

  • Participants which were previously diagnosed with diabetes mellitus
  • Participants which were previously diagnosed with chronic renal failure
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Koray

Bursa, 16230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Behcet SyndromeFibromyalgia

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesUveitis, AnteriorPanuveitisUveitisUveal DiseasesEye DiseasesVasculitisVascular DiseasesCardiovascular DiseasesHereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, VascularMuscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 21, 2018

First Posted

June 1, 2018

Study Start

June 11, 2018

Primary Completion

February 5, 2019

Study Completion

February 5, 2019

Last Updated

February 6, 2019

Record last verified: 2019-02

Locations

TU(1)