Hydroxychloroquine Versus Placebo in Primary Sjögren's Syndrome (JOQUER)
This study has been completed.
Sponsor:
Assistance Publique - Hôpitaux de Paris
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
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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
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 May 22, 2013