Hydroxychloroquine Versus Placebo in Primary Sjögren's Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00632866
• Date of registration: 29/02/2008
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Hydroxychloroquine Versus Placebo in Primary Sjögren's Syndrome JOQUER
• Scientific title: Randomized, Double-blind, Placebo-controlled Trial of Hydroxychloroquine in Primary Sjögren's Syndrome
• Date of first enrolment: March 2008
• Target sample size: 120
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00632866
• 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
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Xavier Mariette, MD, PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Primary Sjögren's Syndrome

Intervention(s)

Drug: Placebo

Drug: Hydroxychloroquine

Primary Outcome(s)

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(s)

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]

Secondary ID(s)

P070125-AOM 07065

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi