NCT01601028

Brief Summary

Primary Sjögren syndrome is one of the most prevalent autoimmune diseases that present with dry eye and dry mouth. But there is no proven effective treatment for Sjögren syndrome patient. The relation between toll-like receptor (TLR) and the pathogenesis of Sjögren syndrome has been reported. Hydroxychloroquine is TLR7 and TLR9 antagonist. A few studies have been reported the effectiveness of Hydroxychloroquine for Sjögren syndrome but no randomized controlled study has been done. So the investigators evaluate the effectiveness and safeness of Hydroxychloroquine for primary Sjögren syndrome by randomized controlled study (Hydroxychloroquine 300 mg once daily p.o. group (N = 30) versus placebo group (N = 30).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2011

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

Study Start

First participant enrolled

July 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 17, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

October 17, 2013

Status Verified

October 1, 2013

Enrollment Period

2.1 years

First QC Date

April 29, 2012

Last Update Submit

October 16, 2013

Conditions

Autoimmune DiseasesSjogren's SyndromeDry Eye

Keywords

Autoimmune DiseasesSjogren's SyndromeHydroxychloroquine

Outcome Measures

Primary Outcomes (1)

  • Serum cytokine level

    IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc.

    16 weeks

Secondary Outcomes (10)

  • Retinal exam

    16 weeks

  • Indicator of inflammation

    16 weeks

  • Tear production

    16 weeks

  • Subjective clinical eye complaints

    16 weeks

  • Tear cytokine level

    16 weeks

  • +5 more secondary outcomes

Study Arms (2)

Hydroxychloroquine

ACTIVE COMPARATOR

Hydroxychloroquine 300 mg once daily p.o.

Drug: Hydroxychloroquine

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

HydroxychloroquineDRUG

Hydroxychloroquine 300 mg once daily p.o. for 12 weeks and go off medication for 4 weeks (total 16 weeks)

Hydroxychloroquine
PlaceboDRUG

2cp/day for 12 weeks and go off medication for 4 weeks (total 16 weeks)

Placebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient who is diagnosed with primary Sjögren syndrome according to American/European consensus group (AECG) criteria
  • Patient with the ability to give informed, dated and signed consent before the beginning of any proceedings related to the trial

You may not qualify if:

  • Previous treated by Hydroxychloroquine but enough washout time after discontinuance of treatment, patient can be enrolled. (2 wks)
  • Known cardiac disease, Respiratory disease, Renal disease, Gastrointestinal disease (except GERD)
  • Diabetes mellitus
  • Psoriasis
  • Known drug allergy or hypersensitivity
  • Previous or ongoing treatment by any drugs (include topical drug) which have effect on lacrimal system. But enough washout time after discontinuance of treatment, patient can be enrolled. (cf. SSRI, Anti-histamine, Pilocarpine, etc.)
  • Angle closer glaucoma
  • Patient who underwent previous intraocular surgery
  • Macular disease
  • Previous or ongoing treatment by drug which could have effect on macula
  • Pregnancy
  • Planning to get pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National Unversity Hospital

Seoul, Seoul, 110-744, South Korea

Location

Related Publications (1)

  • Yoon CH, Lee HJ, Lee EY, Lee EB, Lee WW, Kim MK, Wee WR. Effect of Hydroxychloroquine Treatment on Dry Eyes in Subjects with Primary Sjogren's Syndrome: a Double-Blind Randomized Control Study. J Korean Med Sci. 2016 Jul;31(7):1127-35. doi: 10.3346/jkms.2016.31.7.1127. Epub 2016 Apr 20.

    PMID: 27366013DERIVED

MeSH Terms

Conditions

Autoimmune DiseasesSjogren's SyndromeDry Eye Syndromes

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Immune System DiseasesArthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2012

First Posted

May 17, 2012

Study Start

July 1, 2011

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

October 17, 2013

Record last verified: 2013-10

Locations

KR(1)