Hydroxychloroquine Versus Placebo in Primary Sjögren's Syndrome

NCT ID: NCT00632866

Last Updated: 2012-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2012-05-31

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.

Conditions

Primary Sjögren's Syndrome

Keywords

auto-immune diseases; hydroxychloroquine; primary Sjögren's syndrome; inflammatory arthritides; inflammatory rheumatic diseases; dryness; joint diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Active treatment : Hydroxychloroquine

Group Type: EXPERIMENTAL

Hydroxychloroquine

Intervention Type: DRUG

Hydroxychloroquine : 200mg / day since 24 weeks

2

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo : 2cp/ day since 24 weeks

Interventions

Hydroxychloroquine

Hydroxychloroquine : 200mg / day since 24 weeks

Intervention Type: DRUG

Placebo

Placebo : 2cp/ day since 24 weeks

Intervention Type: DRUG

Other Intervention Names

Plaquenil

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
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xavier Mariette, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hopital Bicëtre

Le Kremlin-Bicêtre, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 25027140 (View on PubMed)

Other Identifiers

P070125-AOM 07065

Identifier Type: -

Identifier Source: org_study_id