Study on Leflunomide and Hydroxychloroquine for Patients with Primary Sjögren’s Syndrome

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What is this study about?

This clinical trial is focused on studying the effects of a combination therapy using leflunomide and hydroxychloroquine for treating primary Sjögren’s Syndrome, a condition that affects the body’s moisture-producing glands, leading to symptoms like dry mouth and eyes. The study aims to evaluate the safety and effectiveness of this treatment combination over a period of 24 weeks, with an additional 24-week follow-up phase. Participants will receive either the active medications or a placebo, which looks like the real medication but does not contain the active ingredients.

During the study, participants will take the medications orally in the form of film-coated tablets. The trial will assess changes in disease activity and symptoms, such as dryness and joint pain, using various tests and patient-reported outcomes. The goal is to determine if the combination of leflunomide and hydroxychloroquine can improve the symptoms of primary Sjögren’s Syndrome compared to a placebo.

The study will also explore whether certain molecular markers can predict how well a patient might respond to the therapy. This research is part of a larger effort to find more effective treatments for primary Sjögren’s Syndrome and to understand the disease better. Participants will be monitored closely throughout the study to ensure their safety and to gather comprehensive data on the treatment’s impact.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age, diagnosis of primary Sjögren’s Syndrome, and other health factors.

Informed consent is required to participate in the study.

2 initial treatment phase

The initial phase lasts for 24 weeks and involves a randomized, placebo-controlled trial.

Participants receive either leflunomide or hydroxychloroquine, or a placebo, administered orally in the form of film-coated tablets.

The main goal is to assess the effectiveness and safety of the medications in treating primary Sjögren’s Syndrome.

3 crossover phase

After the initial 24 weeks, participants enter a single-arm crossover phase.

During this phase, all participants receive the active medications, leflunomide and hydroxychloroquine, to further evaluate their effects.

4 open extension phase

The study continues with an open extension phase, bringing the total duration to 48 weeks.

Participants continue to receive the active medications, allowing for long-term assessment of treatment effects.

5 evaluation and monitoring

Throughout the study, various health parameters are monitored, including changes in disease activity, dryness, and joint symptoms.

The effectiveness of the treatment is measured using specific tests and patient-reported outcomes.

Who Can Join the Study?

Women and men, aged 18-75 years
Diagnosed with primary Sjögren’s Syndrome according to the ACR-EULAR 2016 Criteria for pSS. This means the patient has been diagnosed with a specific condition called primary Sjögren’s Syndrome using guidelines from two medical organizations.
ESSDAI ≥5. This is a score used to measure the activity of the disease. A score of 5 or more is required.
Use of a reliable method of contraception. This means participants must use a dependable way to prevent pregnancy.
Signed written informed consent. This means the patient must read and sign a document that explains the study and agrees to participate.

Who Cannot Join the Study?

Patients who do not have primary Sjögren’s Syndrome cannot participate. This is a condition where the body’s immune system attacks its own moisture-producing glands.
Patients who are not within the specified age range cannot participate. The age range for this study is from 18 to 65 years old.
Patients who are part of a vulnerable population cannot participate. This means people who might be at higher risk of harm or exploitation.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	12.10.2021

Trial locations

Investigated drugs:

Leflunomide is a medication that is being studied for its potential to help people with primary Sjögren’s Syndrome. It is typically used to reduce inflammation and slow down the immune system, which may help in managing symptoms of this condition.

Hydroxychloroquine is another medication involved in the study. It is commonly used to treat autoimmune diseases by reducing inflammation and modulating the immune system. In this trial, it is being tested in combination with Leflunomide to see if it can improve the symptoms of primary Sjögren’s Syndrome.

Investigated diseases:

Sjogren's syndrome

Primary Sjögren’s Syndrome – This is an autoimmune disease 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 joints, skin, and organs. The disease can cause fatigue and joint pain, and in some cases, it may lead to complications in organs like the kidneys and lungs. The progression of symptoms can vary widely among individuals, with some experiencing mild discomfort and others facing more severe issues.

Trial ID:

2024-510904-36-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Leflunomide and Hydroxychloroquine for Patients with Primary Sjögren’s Syndrome

What is this study about?

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