NCT04022421

Brief Summary

Patients diagnosed with Behcet's disease will be randomized to administeration of hydroxychloroquine. Assessment will be done for the patients at baseline and every one month in the first three months and then quarterly for one year.

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 Oct 2018

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

Study Start

First participant enrolled

October 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2019

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

10 months

First QC Date

July 15, 2019

Last Update Submit

July 23, 2019

Conditions

Behcet's Syndrome, Vascular Type

Outcome Measures

Primary Outcomes (1)

  • Prevention of the recurrence of thrombotic events

    number of relapses is expected to fall with the longterm use of the drug

    6 months- one year

Study Arms (1)

hydroxychloroquine arm

EXPERIMENTAL
Drug: Hydroxychloroquine

Interventions

HydroxychloroquineDRUG

the drug will be taken by one group of the patients daily at a dose of 400mg

hydroxychloroquine arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients diagnosed with Behcet's disease on any DMARDs

You may not qualify if:

  • Patients with critical conditions
  • Patients with hypersensitivity or adverse drug reactions to hydroxychloroquine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Behcet Syndrome

Interventions

Hydroxychloroquine

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, Vascular

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Alaa Mohamed, Post-doctor

CONTACT

+20882413177a.a.a.mohamed@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 15, 2019

First Posted

July 17, 2019

Study Start

October 1, 2018

Primary Completion

August 1, 2019

Study Completion

October 1, 2019

Last Updated

July 25, 2019

Record last verified: 2019-07

Locations

EG(1)