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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00632866
First received: February 29, 2008
Last updated: July 1, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Primary Sjögren's Syndrome
Drug: Hydroxychloroquine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled Trial of Hydroxychloroquine in Primary Sjögren's Syndrome

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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 [ Time Frame: 6 mois ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: March 2008
Study Completion Date: May 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Active treatment : Hydroxychloroquine
Drug: Hydroxychloroquine
Hydroxychloroquine : 200mg / day since 24 weeks
Other Name: Plaquenil
Placebo Comparator: 2
Placebo
Drug: Placebo
Placebo : 2cp/ day since 24 weeks
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632866

Locations
France
Hopital Bicëtre
Le Kremlin Bicetre, France, 94275
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Sanofi
Investigators
Principal Investigator: Xavier Mariette, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00632866     History of Changes
Other Study ID Numbers: P070125-AOM 07065
Study First Received: February 29, 2008
Last Updated: July 1, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
auto-immune diseases
hydroxychloroquine
primary Sjögren's syndrome
inflammatory arthritides
inflammatory rheumatic diseases
dryness
joint diseases

Additional relevant MeSH terms:
Sjogren's Syndrome
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Hydroxychloroquine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 08, 2014