Hydroxychloroquine Versus Placebo in Primary Sjögren's Syndrome

Phase 3

Completed

• Conditions: Primary Sjögren's Syndrome
• Interventions: Drug: Hydroxychloroquine; Drug: Placebo

• Registration Number: NCT00632866
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2008-02-29
• Study First Submitted QC: 2008-02-29
• Study Start: 2008-03
• Study First Posted: 2008-03-11
• Primary Completion: 2011-05
• Study Completion: 2012-05
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-01
• Last Update Posted: 2012-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Hydroxychloroquine	Active treatment : Hydroxychloroquine
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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	6 months

Secondary Outcome Measures

Name	Time	Method
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	6 mois

Trial Locations

Locations (1)

Hopital Bicëtre; 🇫🇷 Le Kremlin Bicetre, France