NCT05488561

Brief Summary

Familial Mediterranean fever (FMF ,recurrent polyserositis ,periodic disease) is an autosomal recessive auto inflammatory disease which primarily affect population surrounding the Mediterranean basin (Arabs , Turks ,Armenians, Jews ).Despite its striking symptoms pattern FMF was first described as distinct entity only in 1945. It is characterized by recurrent attacks of fever , peritonitis ,pleurisy , arthritis , or erysipelas like skin disease. The most dangerous complication of this disease is secondary amyloidosis . FMF diagnosis is mainly clinical, and the genetic testing is indicated to support it . Uncommonly, amyloidosis may develop in individuals carrying two Familial Mediterranean fever gene (MEFV ) mutations without overt clinical symptoms of FMF, a condition designated as phenotype II. Furthermore, two MEFV mutations may be harbored without signs or symptoms of FMF nor of reactive amyloidosis. This 'silent' homozygous or compound heterozygote state is termed phenotype III.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

August 3, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

12 months

First QC Date

August 3, 2022

Last Update Submit

August 3, 2022

Conditions

Familial Mediterranean Fever

Outcome Measures

Primary Outcomes (3)

  • CBC

    leucocytosis

    12 month

  • amyloid level

    high in untreated patients

    12 month

  • FMF gene

    positive or negative

    12 month

Interventions

CBC with differential ,ESR ,CRP, Amyloid level , FMF geneDIAGNOSTIC_TEST

leucocytosis , high ESR and CRP ,amyloid level indicates inflammation positive FMF gene indicates having the disease .

Also known as: liver and kidney function tests

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • A- all children diagnosed as FMF according to Tel hashomer criteria aged below 18 years:
  • Fever axillary temperature of \>38ᵒC, 6-72 h of duration, ≥3 attacks
  • Abdominal pain 6-72 h of duration ≥3 attacks
  • Chest pain 6-72 h duration≥ 3 attacks
  • Arthritis 6-72 h duration ≥3 attacks, oligoarthritis
  • Family history of FMF\*(11) B-sisters and brothers of a child with FMF with clinical or subclinical manifestation of FMF.

You may not qualify if:

  • Children with other auto inflammatory diseases, or with other diseases.
  • Persons above 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

  • Alghamdi M. Familial Mediterranean fever, review of the literature. Clin Rheumatol. 2017 Aug;36(8):1707-1713. doi: 10.1007/s10067-017-3715-5. Epub 2017 Jun 18.

    PMID: 28624931BACKGROUND

  • Cakan M, Karadag SG, Tanatar A, Sonmez HE, Ayaz NA. The Value of Serum Amyloid A Levels in Familial Mediterranean Fever to Identify Occult Inflammation During Asymptomatic Periods. J Clin Rheumatol. 2021 Jan 1;27(1):1-4. doi: 10.1097/RHU.0000000000001134.

    PMID: 31524848BACKGROUND

  • Ozdogan H, Ugurlu S. Familial Mediterranean Fever. Presse Med. 2019 Feb;48(1 Pt 2):e61-e76. doi: 10.1016/j.lpm.2018.08.014. Epub 2019 Jan 25.

    PMID: 30686512BACKGROUND

  • Talaat HS, Sheba MF, Mohammed RH, Gomaa MA, Rifaei NE, Ibrahim MFM. Genotype Mutations in Egyptian Children with Familial Mediterranean Fever: Clinical Profile, and Response to Colchicine. Mediterr J Rheumatol. 2020 Jun 15;31(2):206-213. doi: 10.31138/mjr.31.2.206. eCollection 2020 Jun.

    PMID: 32676558BACKGROUND

MeSH Terms

Conditions

Familial Mediterranean Fever

Interventions

Blood Cell CountKidney Function Tests

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaDiagnostic Techniques, Urological

Central Study Contacts

nahla a fawy, resident

CONTACT

01015681398nahlaabdelaziz@med.sohag.edu.eg

ashraf m redwan, assisstant professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at pediatric department at faculty of medicine sohag university hospital

Study Record Dates

First Submitted

August 3, 2022

First Posted

August 4, 2022

Study Start

August 15, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

August 4, 2022

Record last verified: 2022-08

Locations

EG(1)