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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
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
Address: 
Telephone:
Email:
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: Hydroxychloroquine
Drug: Placebo
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
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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