Study on Hydroxychloroquine, Leflunomide, and Mycophenolate Mofetil for Patients with Primary Sjogren’s Syndrome

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What is this study about?

This clinical trial is focused on studying Primary Sjögren’s Syndrome, a condition that affects the body’s moisture-producing glands, leading to symptoms like dry mouth and eyes. The study will explore the effectiveness of different treatment combinations to help manage this condition. The treatments being tested include a combination of hydroxychloroquine with leflunomide, and hydroxychloroquine with mycophenolate mofetil. These medications are commonly used to treat autoimmune diseases, where the immune system mistakenly attacks the body’s own tissues.

The purpose of the study is to evaluate how well these treatment combinations work in improving the symptoms of Primary Sjögren’s Syndrome. Participants in the study will receive one of the treatment combinations or a placebo. The study will last for a period of 24 weeks, during which the participants’ responses to the treatments will be monitored and assessed. The goal is to determine the proportion of patients who show improvement in their symptoms by the end of the study period.

Throughout the study, participants will be closely monitored to ensure their safety and to gather data on the effectiveness of the treatments. This research aims to provide valuable insights into better managing Primary Sjögren’s Syndrome and improving the quality of life for those affected by this condition.

1 joining the study

Upon joining the study, the patient is required to provide written informed consent. This is a formal agreement to participate in the trial after understanding its purpose and procedures.

2 initial assessment

An initial assessment is conducted to confirm the diagnosis of primary Sjögren’s syndrome. This includes meeting specific criteria set by medical organizations.

A pregnancy test is performed for female patients to ensure eligibility.

3 treatment allocation

Patients are assigned to one of the treatment groups. The treatments involve combinations of medications taken orally.

The medications used are hydroxychloroquine sulfate, mycophenolate mofetil, and leflunomide. Each medication is provided in the form of film-coated tablets.

4 medication administration

The patient takes hydroxychloroquine sulfate as part of the treatment regimen. The dosage is 200 mg per tablet.

If assigned to the combination with mycophenolate mofetil, the patient takes 500 mg tablets.

If assigned to the combination with leflunomide, the patient takes 20 mg tablets.

The frequency and duration of administration are determined by the study protocol, with a focus on achieving the desired response by week 24.

5 monitoring and evaluation

Throughout the trial, the patient’s response to the treatment is monitored. This involves regular check-ups and assessments to evaluate the effectiveness of the medication.

The primary goal is to determine the proportion of patients who respond positively to the treatment by week 24.

6 completion of the trial

The trial is expected to conclude by January 25, 2026. At this point, the final assessments are conducted to gather data on the treatment’s efficacy.

The results will contribute to understanding the best treatment options for patients with primary Sjögren’s syndrome.

Who Can Join the Study?

Must have given written informed consent before starting any study-related procedures. This means you agree to participate and understand what the study involves.
Must use highly reliable contraception during the study treatment, starting from the screening and continuing for two years after stopping treatment. This is to prevent pregnancy during and after the study.
Must have a negative pregnancy test at the start of the study (checked through a blood test).
Must be diagnosed with Primary Sjogren’s syndrome (pSS) according to specific medical criteria (ACR/EULAR 2016 or AECG 2002). These are guidelines used by doctors to confirm the condition.
For Cohort 1: Must have a high level of symptoms, with a score of 5 or more on the ESSPRI scale, which measures symptoms like dryness, pain, and fatigue. Must also have low systemic disease activity, meaning the disease is not affecting the whole body severely.
For Cohort 2: Must have moderate to high systemic disease activity, with a score of 5 or more on the ESSDAI scale, which measures how much the disease is affecting the body.

Who Cannot Join the Study?

Patients who are pregnant or breastfeeding cannot participate.
Individuals with a history of severe allergic reactions to the study medications are excluded. This means if you have had a serious allergic response to the drugs being tested, you cannot join.
People with other autoimmune diseases, which are conditions where the body’s defense system attacks its own tissues, are not eligible.
Participants who have had recent infections that required treatment with antibiotics or antiviral medications are excluded. This means if you have had an infection needing these treatments recently, you cannot take part.
Individuals with significant liver or kidney problems cannot participate. These are important organs in your body, and if they are not working well, you cannot join the study.
Patients who are currently using other medications that might interfere with the study drugs are not eligible. This means if you are taking certain other medicines, you cannot participate.
People with a history of cancer within the last five years, except for certain types of skin cancer, are excluded. This means if you have had cancer recently, you cannot join, unless it was a specific type of skin cancer.
Individuals with uncontrolled high blood pressure, which means your blood pressure is not well-managed, cannot participate.
Participants who have had a recent heart attack or stroke are excluded. These are serious conditions affecting the heart and brain.
People with a history of drug or alcohol abuse within the past year cannot join the study. This means if you have had problems with drugs or alcohol recently, you are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Helse Stavanger HF	Stavanger	Norway
Azienda Ospedaliera Di Perugia	Perugia	Italy
Universita’ Di Pisa	Pisa	Italy
National And Kapodistrian University Of Athens	Athens	Greece
University General Hospital Of Ioannina	Ioannina	Greece
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Centre Hospitalier Le Mans	Le Mans	France
Karolinska University Hospital	Solna	Sweden
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Hopital Beaujon	Clichy	France
University Of Skane	Malmo	Sweden
Uzepzepgpvtz Mftxqsr Cxulwzy Gthhhpanm	Groningen	The Netherlands
Pbbu Toblr Hxvankah Ufzokxxarrfe	Sabadell	Spain
Usyuiqt Ugvrlqzklm Hopyqyje	Uppsala	Sweden
Hnxsi Brurwm Hu	Bergen	Norway
Hrgbretc Vrgi dquojxnf	Barcelona	Spain
Hdaerqhx Urpmxoliexfqta Shuimmydbl &palktd Hrpuwnu dy Htnwvdbkrgw	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	26.04.2022
Greece	Not recruiting	26.04.2022
Italy	Not recruiting	26.04.2022
Norway	Not recruiting	26.04.2022
Spain	Not recruiting	26.04.2022
Sweden	Not recruiting	26.04.2022
The Netherlands	Not recruiting	26.04.2022

Trial locations

Investigated drugs:

Hydroxychloroquine is a medication commonly used to treat autoimmune diseases. In this trial, it is being tested in combination with other drugs to see if it can help improve symptoms in patients with primary Sjögren’s Syndrome.

Leflunomide is a medication that helps reduce inflammation and is often used to treat rheumatoid arthritis. In this study, it is combined with hydroxychloroquine to evaluate its effectiveness in treating primary Sjögren’s Syndrome.

Mycophenolate mofetil is an immunosuppressant drug that is used to prevent the body from rejecting transplanted organs and to treat autoimmune diseases. In this trial, it is being used alongside hydroxychloroquine to assess its potential benefits for patients with primary Sjögren’s Syndrome.

Investigated diseases:

Sjogren's syndrome

Primary Sjogren’s Syndrome – This is an autoimmune disorder where the body’s immune system mistakenly attacks its own moisture-producing glands. It primarily affects the salivary and tear glands, leading to symptoms such as dry mouth and dry eyes. Over time, it can also affect other parts of the body, including the joints, thyroid, kidneys, liver, lungs, skin, and nerves. The disease progresses slowly, and symptoms can vary widely among individuals. Some people may experience fatigue and joint pain, while others might have more severe complications affecting internal organs. The exact cause of Primary Sjogren’s Syndrome is not fully understood, but it is believed to involve a combination of genetic and environmental factors.

Trial ID:

2023-510054-16-00

Protocol code:

APHP190131

NCT ID:

NCT05113004

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Hydroxychloroquine, Leflunomide, and Mycophenolate Mofetil for Patients with Primary Sjogren’s Syndrome

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