CompletedNot Applicable

Hydroxychloroquine Blood Levels in Primary Sjögren Syndrome Patients

Brazil74 participantsStarted 2020-10-01

Plain-language summary

Introduction. Primary Sjögren's syndrome (pSS) is an autoimmune disease characterized by chronic inflammatory infiltration of the salivary and lacrimal glands causing dry eye and mouth. Multiple systemic manifestations can also occur. Hydroxychloroquine (HCQ), an antimalarial immunomodulator, has been used for the treatment of arthralgias, myalgia and constitutional symptoms resulting from pSS. However, there are no studies that evaluated whether blood levels of HCQ could influence in the therapeutic response, as has been reported in systemic lupus erythematosus (SLE). Objectives. Analyze in patients with pSS receiving HCQ as part of their treatment: blood levels of HCQ; adherence using a questionnaire versus blood levels and the possible correlation of blood levels with the disease activity score in a cross-sectional evaluation followed by a longitudinal six-month assessment. Patients and methods. Observational cross-sectional evaluation followed by a six-month longitudinal assessment, including patients with pSS receiving HCQ for at least 3 months at study admission. Patients will be evaluated clinically and the HCQ blood level measured at the beginning of the study (T0), at 3 months (T3), and at 6 months (T6). As there are no previous studies on blood levels of HCQ in patients with pSS, the sample of 75 patients was calculated based on the percentage of these patients currently using HCQ in our service (nearly 50%) and in the number of patients in current follow-up (about 150). We will evaluate 75 adult patients with pSS according to the classification criteria of the American-European Consensus Group 2002 and/or the American College of rheumatology (ACR) and the European League Against Rheumatism (EULAR) 2016, of both sexes and followed up regularly at the Sjögren Syndrome outpatient Clinic of the Rheumatology Service of "Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP)". The following will be used in the clinical evaluation: the xerostomia Inventory; the xerophthalmia questionnaire - Ocular Surface Disease Index (OSDI); the EULAR Sjögren Syndrome Reported Index (ESSPRI); the EULAR Sjögren Syndrome Disease Activity Index (ESSDAI); the Sjögren's Syndrome Disease Damage Index (SSDDI); the non-stimulated and stimulated salivary flow. Blood levels of HCQ will be measured by high performance liquid chromatography and tandem mass spectrometry.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * pSS according to the classification criterias * Who have been receiving HCQ for at least 3 months before study entry * Patients who agree to participate in the study, according to the signing of the Free and Informed Consent Term (ICF). Exclusion Criteria: * Present other associated systemic autoimmune diseases, such as rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, demato/polymyositis, mixed connective tissue disease, spondyloarthritis, primary biliary cholangitis and autoimmune hepatitis; * Present a previous history of radiotherapy of the head and neck, positive serologies for HIV, hepatitis B and C, sarcoidosis, graft versus host disease and IgG4-related disease; * Use of drugs that can interact with HCQ or interfere in HCQ blood levels (tamoxifen, antacids and digoxin), alcoholism, current infections, liver and heart failure, dialysis, severe chronic renal failure (serum creatinine ≥3 mg/dL) and pregnancy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline of HCQ blood levels at 3 and 6 months

Timeframe: Baseline, 3 and 6 months

Trial details

NCT IDNCT04546542

SponsorUniversity of Sao Paulo General Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-02-22

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