Sjogren's Syndrome1ASSJHCQNCT04546542
Hydroxychloroquine Blood Levels in Primary Sjögren Syndrome Patients
An observational study of Sjogren's Syndrome, run by University of Sao Paulo General Hospital at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjogren's Syndrome
- What is being tested?
- Parallel Assignment
- How many people
- 74 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Oct 2020to 22 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 05403-000
Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, 05403-000
About this study
Official title: Analysis of Hydroxychloroquine Blood Levels in Patients With Primary Sjögren Syndrome and Possible Correlation With the Disease Activity
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.
- Conditions
- Sjogren's Syndrome
- Being tested
- Parallel Assignment
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parallel AssignmentOther
Also called pSS
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Parallel Assignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of HCQ blood levels at 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).
Measured: Baseline, 3 and 6 months
Secondary outcomes (2)
HCQ adherence in pSS patients
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
Measured: Baseline, 3 and 6 months
Disease activity in pSS patients
We will evaluate the disease activity in pSS patients and correlate if HCQ blood levels can predict risk of disease acrivity
Measured: Baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start1 Oct 2020
- Primary completion22 Feb 2024
- Study completion22 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546542
- Sponsor's protocol ID
- 1ASSJ
- Acronym
- 1ASSJHCQ
- Status last verified
- Feb 2024
- First submitted
- 27 Aug 2020
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pedrosa TN, Pasoto SG, Aikawa NE, Yuki EF, Borba EF, Filho JCF, Carricondo PC, Zanetti CB, Conde PG, Duarte NJ, Fontoura N, Romano P, Carvalho VM, Silva CA, Bonfa E. Understanding the dynamics of hydroxychloroquine blood levels in lupus nephritis. Lupus. 2020 May;29(6):560-568. doi: 10.1177/0961203320912832. Epub 2020 Mar 19. No abstract available.
PubMed 32192398Cankaya H, Alpoz E, Karabulut G, Guneri P, Boyacioglu H, Kabasakal Y. Effects of hydroxychloroquine on salivary flow rates and oral complaints of Sjogren patients: a prospective sample study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Jul;110(1):62-7. doi: 10.1016/j.tripleo.2010.02.032.
PubMed 20610299Yavuz S, Asfuroglu E, Bicakcigil M, Toker E. Hydroxychloroquine improves dry eye symptoms of patients with primary Sjogren's syndrome. Rheumatol Int. 2011 Aug;31(8):1045-9. doi: 10.1007/s00296-010-1415-4. Epub 2010 Mar 23.
PubMed 20309693
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Hydroxychloroquine Blood Levels in Patients With Primary Sjögren Syndrome and Possible Correlation With the Disease Activity
- ClinicalTrials.gov ID
- NCT04546542
- Acronym / sponsor ID
- 1ASSJHCQ / 1ASSJ
- Conditions
- Sjogren's Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pSS patients under Hydroxychloroquine (HCQ) 2016-AAO dose | – | Other: Parallel AssignmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parallel AssignmentAlso: pSSWe 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 | pSS patients under Hydroxychloroquine (HCQ) 2016-AAO dose |
Primary outcome
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).
2 secondary outcomes
HCQ adherence in pSS patients
Time frame: Baseline, 3 and 6 months
Disease activity in pSS patients
Time frame: Baseline, 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Results publication: PubMed 32192398Pedrosa TN, Pasoto SG, Aikawa NE, Yuki EF, Borba EF, Filho JCF, Carricondo PC, Zanetti CB, Conde PG, Duarte NJ, Fontoura N, Romano P, Carvalho VM, Silva CA, Bonfa E. Understanding the dynamics of hydroxychloroquine blood levels in lupus nephritis. Lupus. 2020 May;29(6):560-568. doi: 10.1177/0961203320912832. Epub 2020 Mar 19. No abstract available.
- Results publication: PubMed 20610299Cankaya H, Alpoz E, Karabulut G, Guneri P, Boyacioglu H, Kabasakal Y. Effects of hydroxychloroquine on salivary flow rates and oral complaints of Sjogren patients: a prospective sample study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Jul;110(1):62-7. doi: 10.1016/j.tripleo.2010.02.032.
- Results publication: PubMed 20309693Yavuz S, Asfuroglu E, Bicakcigil M, Toker E. Hydroxychloroquine improves dry eye symptoms of patients with primary Sjogren's syndrome. Rheumatol Int. 2011 Aug;31(8):1045-9. doi: 10.1007/s00296-010-1415-4. Epub 2010 Mar 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sjogren's Syndrome, run by University of Sao Paulo General Hospital at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of HCQ blood levels at 3 and 6 months (time frame: Baseline, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04546542, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.