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Hydroxychloroquine Blood Levels in Primary Sjögren Syndrome Patients (1ASSJHCQ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04546542
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : November 4, 2020
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief 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 and the 8-item Morisky Medication Adherence Scale. Blood levels of HCQ will be measured by high performance liquid chromatography and tandem mass spectrometry.

Condition or disease Intervention/treatment
Sjogren's Syndrome Other: Parallel Assignment

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Hydroxychloroquine Blood Levels in Patients With Primary Sjögren Syndrome and Possible Correlation With the Disease Activity
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
pSS patients under Hydroxychloroquine (HCQ) 2016-AAO dose
Patients under Hydroxychloroquine (HCQ) 2016-American Academy of ophtalmology (AAO) dose will have HCQ blood levels, disease activity and adherence evaltuated at study entry and before 3 and 6-months.
Other: Parallel Assignment
We will evaluate 75 patients with pSS (Consenso Americano-europeu de 2002 / EULAR/ACR Classification Criteria, 2016) of both sexes at baseline and 6-months
Other Name: pSS

Primary Outcome Measures :
  1. Change from baseline of HCQ blood levels at 3 and 6 months [ Time Frame: Baseline, 3 and 6 months ]
    Hydroxychloroquine blood levels will be measure using liquid chromatography tandem Mass Spectrometry (LC-MS/MS), as previously described (PEDROSA et al., 2020).

Secondary Outcome Measures :
  1. HCQ adherence in pSS patients [ Time Frame: Baseline, 3 and 6 months ]
    Will be analysed the possible correlation between MTA (measure for treatment adhernce - a quesionnaire of adherence) score and HCQ blood levels em ng/mL (using liquid chromatography tandem Mass Spectrometry (LC-MS/MS), as previously described (PEDROSA et al., 2020). For SLE patients, adherence by HCQ blood levels is defined when HCQ blood levels are >500 ng/mL, this value in pSS patients will be estimated using this 2 assessements

  2. Disease activity in pSS patients [ Time Frame: Baseline, 3 and 6 months ]
    We will evaluate the disease activity in pSS patients and correlate if HCQ blood levels can predict risk of disease acrivity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pSS patients according to the classification criterias regularly followed at outpatient clinic, Rheumathology division of Hospital das Clinicas da Universidade de Sao Paulo

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04546542

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Contact: Sandra Pasoto +55 11 30617490

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Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo Recruiting
São Paulo, Sao Paulo, Brazil, 05403-000
Contact: Eloisa Bonfa, MD, PhD    55 11 30617490   
Hospital das Clinicas da Faculdade de Medicina da USP Recruiting
São Paulo, Brazil, 05403-000
Contact: Sandra G Pasoto, M.D., PhD.    30617490   
Contact: Nadia E Aikawa, M.D., PhD.    30617490   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Publications of Results:
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Responsible Party: University of Sao Paulo General Hospital Identifier: NCT04546542    
Other Study ID Numbers: 1ASSJ
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sjogren's Syndrome
Pathologic Processes
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases