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Hydroxychloroquine Versus Placebo in Primary Sjögren's Syndrome (JOQUER)

Primary Purpose

Primary Sjögren's Syndrome

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Hydroxychloroquine
Placebo
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Sjögren's Syndrome focused on measuring auto-immune diseases, hydroxychloroquine, primary Sjögren's syndrome, inflammatory arthritides, inflammatory rheumatic diseases, dryness, joint diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Patients suffering from primary Sjögren's syndrome according to the European-American consensus group criteria
  • Male and female aged of 18 or more
  • Conducting a clinical examination beforehand.
  • Having undergone less than 6 months before an ophthalmological examination, which did not counter-indicated hydroxychloroquine.
  • Patient without heart conduction disturbance (PR>=0.2 sec and QRS>=0.08 sec).
  • Patient with the ability to give informed, dated and signed consent before the beginning of any proceedings related to the trial
  • Patients treated with corticosteroids and / or NSAIDs, and / or cyclosporine, and / or pilocarpine must have received stable doses of these treatments during the month preceding inclusion.

Exclusion criteria:

  • SJ associated with other autoimmune diseases
  • Retinopathy /severe cataract/ monophthalmos
  • Previous or ongoing treatment by hydroxychloroquine
  • Treatment by another immunosuppressant not interrupted at least 4 weeks prior to inclusion, or 6 months prior to inclusion for cyclophosphamide or rituximab
  • lymphoma or other severe SJp complications: vasculitis responsible for a documented renal, neurological, digestive or heart involvement, glomerular disease associated with hematuria and / or proteinuria > 0.5 g / d), CNS involvement, peripheral neurological involvement with motor deficiency scored at 3 or less on a scale of 5 , interstitial pneumonitis, recent symptomatic cryoglobulinemia with neurological, renal, or other systemic involvement, myositis with motor deficiency (isolated purpura is not an exclusion criteria)
  • Chronic Alcoholism
  • Hepato-cellular insufficiency
  • Creatinine clearance <60 ml / min
  • Risk of lost follow-up
  • People younger than 18, major trusteeship and guardianship, or deprived of liberty
  • Pregnancy /Breastfeeding
  • Hypersensitivity to chloroquine or to hydroxychloroquine or any of the other constituents of Plaquenil
  • Psoriasis or intermittent porphyria.
  • G6PD deficiency, congenital galactosemia, malabsorption syndrome, glucose and galactose, or lactase deficiency.
  • Non-membership in a social security system.

Sites / Locations

  • Hopital Bicëtre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Active treatment : Hydroxychloroquine

Placebo

Outcomes

Primary Outcome Measures

Proportion of patients with an improvement of 30% or more of at least 2 out of the 3 following VAS: 1. the most disabling dryness 2. pain 3. fatigue

Secondary Outcome Measures

SCHIRMER's test, van BIJSTERVELD score, salivary flow, disease systemic features, quality of life, interferon-inducible genes expression Association between clinical response and hydroxychloroquine blood level, interferon-inducible genes expression

Full Information

First Posted
February 29, 2008
Last Updated
July 1, 2012
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00632866
Brief Title
Hydroxychloroquine Versus Placebo in Primary Sjögren's Syndrome
Acronym
JOQUER
Official Title
Randomized, Double-blind, Placebo-controlled Trial of Hydroxychloroquine in Primary Sjögren's Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary Sjögren's syndrome (SJp) affects 0.1% of the population. This systemic autoimmune disease systemic is characterized by disabling dryness, fatigue and pain, and systemic complications in 30% of patients. No treatment has proven effective in this disease. In open studies, some efficacy was observed with hydroxychloroquine but no RCT versus placebo has ever been done. Thus, the primary purpose of this study is to evaluate the efficacy and safety of hydroxychloroquine (400mg/ day) on dryness, pain, and fatigue, assessed by the patient using visual analogical scales.
Detailed Description
Primary Sjögren's syndrome (SJp) affects 0.1% of the population. This systemic autoimmune disease systemic is characterized by disabling dryness, fatigue and pain, and systemic complications in 30% of patients. No treatment has proven effective in this disease. In open studies, some efficacy was observed with hydroxychloroquine but no RCT versus placebo has ever been done. Thus, the primary purpose of this study is to evaluate the efficacy and safety of hydroxychloroquine (400mg/ day) on dryness, pain, and fatigue, assessed by the patient using visual analogical scales (VAS). Response is defined by the improvement of 30% or more of at least 2 out of 3 of the following VAS : most disabling dryness, fatigue, and pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Sjögren's Syndrome
Keywords
auto-immune diseases, hydroxychloroquine, primary Sjögren's syndrome, inflammatory arthritides, inflammatory rheumatic diseases, dryness, joint diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Active treatment : Hydroxychloroquine
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Other Intervention Name(s)
Plaquenil
Intervention Description
Hydroxychloroquine : 200mg / day since 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo : 2cp/ day since 24 weeks
Primary Outcome Measure Information:
Title
Proportion of patients with an improvement of 30% or more of at least 2 out of the 3 following VAS: 1. the most disabling dryness 2. pain 3. fatigue
Time Frame
6 months
Secondary Outcome Measure Information:
Title
SCHIRMER's test, van BIJSTERVELD score, salivary flow, disease systemic features, quality of life, interferon-inducible genes expression Association between clinical response and hydroxychloroquine blood level, interferon-inducible genes expression
Time Frame
6 mois

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients suffering from primary Sjögren's syndrome according to the European-American consensus group criteria Male and female aged of 18 or more Conducting a clinical examination beforehand. Having undergone less than 6 months before an ophthalmological examination, which did not counter-indicated hydroxychloroquine. Patient without heart conduction disturbance (PR>=0.2 sec and QRS>=0.08 sec). Patient with the ability to give informed, dated and signed consent before the beginning of any proceedings related to the trial Patients treated with corticosteroids and / or NSAIDs, and / or cyclosporine, and / or pilocarpine must have received stable doses of these treatments during the month preceding inclusion. Exclusion criteria: SJ associated with other autoimmune diseases Retinopathy /severe cataract/ monophthalmos Previous or ongoing treatment by hydroxychloroquine Treatment by another immunosuppressant not interrupted at least 4 weeks prior to inclusion, or 6 months prior to inclusion for cyclophosphamide or rituximab lymphoma or other severe SJp complications: vasculitis responsible for a documented renal, neurological, digestive or heart involvement, glomerular disease associated with hematuria and / or proteinuria > 0.5 g / d), CNS involvement, peripheral neurological involvement with motor deficiency scored at 3 or less on a scale of 5 , interstitial pneumonitis, recent symptomatic cryoglobulinemia with neurological, renal, or other systemic involvement, myositis with motor deficiency (isolated purpura is not an exclusion criteria) Chronic Alcoholism Hepato-cellular insufficiency Creatinine clearance <60 ml / min Risk of lost follow-up People younger than 18, major trusteeship and guardianship, or deprived of liberty Pregnancy /Breastfeeding Hypersensitivity to chloroquine or to hydroxychloroquine or any of the other constituents of Plaquenil Psoriasis or intermittent porphyria. G6PD deficiency, congenital galactosemia, malabsorption syndrome, glucose and galactose, or lactase deficiency. Non-membership in a social security system.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Mariette, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Bicëtre
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25027140
Citation
Gottenberg JE, Ravaud P, Puechal X, Le Guern V, Sibilia J, Goeb V, Larroche C, Dubost JJ, Rist S, Saraux A, Devauchelle-Pensec V, Morel J, Hayem G, Hatron P, Perdriger A, Sene D, Zarnitsky C, Batouche D, Furlan V, Benessiano J, Perrodeau E, Seror R, Mariette X. Effects of hydroxychloroquine on symptomatic improvement in primary Sjogren syndrome: the JOQUER randomized clinical trial. JAMA. 2014 Jul 16;312(3):249-58. doi: 10.1001/jama.2014.7682.
Results Reference
derived

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Hydroxychloroquine Versus Placebo in Primary Sjögren's Syndrome

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