Study on Hydroxychloroquine and Prednisone for Patients with Non-Severe Extra-Pulmonary Sarcoidosis

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What is this study about?

This clinical trial is focused on studying a condition called extra-pulmonary sarcoidosis, which affects parts of the body other than the lungs. The study is investigating the use of a medication called hydroxychloroquine as a way to reduce the need for another medication, prednisone, which is a type of steroid. Steroids are often used to treat inflammation in the body, but they can have side effects, so finding ways to use less of them can be beneficial.

The purpose of the study is to see if adding hydroxychloroquine to the treatment plan can help patients with non-severe extra-pulmonary sarcoidosis who need systemic treatment, meaning treatment that affects the whole body. Participants in the study will be randomly assigned to receive either hydroxychloroquine or a placebo, in addition to their regular treatment. The study will last for a period of up to 24 months, with regular check-ups to monitor the effects of the treatment and any side effects.

Throughout the study, doctors will assess how well the treatment is working by looking at the improvement in symptoms and the ability to reduce the use of prednisone. They will also monitor for any side effects related to the medications. The goal is to determine if hydroxychloroquine can effectively help manage the condition while minimizing the need for steroids, ultimately improving the quality of life for patients with extra-pulmonary sarcoidosis.

1 joining the trial

Upon joining the trial, you will be informed about the study’s purpose and procedures. You will be required to provide written consent, confirming your understanding and agreement to participate.

2 initial assessment

An initial assessment will be conducted to evaluate your current health status. This may include a physical examination, blood tests, and other necessary evaluations to ensure eligibility for the trial.

3 medication administration

You will be randomly assigned to receive either hydroxychloroquine sulfate or a placebo. The medication is taken orally in the form of a film-coated tablet. The dosage and frequency will be determined by the study protocol and communicated to you by the study team.

4 regular follow-up visits

Regular follow-up visits will be scheduled at months 1, 3, 6, 12, 18, and 24. During these visits, your health will be monitored, and any side effects or changes in your condition will be assessed. This includes eye evaluations and heart monitoring.

5 primary endpoint assessment

At month 12, the primary endpoint will be assessed. This involves evaluating whether you are in remission and off prednisone without relapse.

6 secondary endpoint assessments

Throughout the trial, secondary endpoints will be assessed, including organ-specific responses, global clinical responses, and quality of life evaluations using the SF36 questionnaire.

7 completion of the trial

The trial is expected to conclude by September 2028. Upon completion, you will receive information about the study’s findings and any further steps if necessary.

Who Can Join the Study?

Must be at least 18 years old.
Have a condition called non-severe sarcoidosis that affects areas outside the lungs, such as the ears, nose, throat, eyes, skin, bones, joints, or peripheral nerves, and requires treatment that affects the whole body.
Have a confirmed diagnosis of sarcoidosis based on specific medical criteria.
Be able to provide informed and written consent to participate in the study.
Be affiliated with the National French social security system.

Who Cannot Join the Study?

Patients with other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had an allergic reaction to hydroxychloroquine or similar medications in the past.
Patients who are currently participating in another clinical trial.
Patients who have a history of eye problems related to retinopathy, which is damage to the retina of the eye.
Patients with severe liver or kidney disease.
Patients who have a history of heart rhythm problems.
Patients who are unable to follow the study procedures or attend the required visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Centre Hospitalier D Avignon	Avignon	France
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Centre Hospitalier Saint Joseph Saint Luc	Lyon	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Hôpital Pontchaillou-CHU Rennes	Rennes	France
Czdsgo Hqixfwgmsmo Uxkpybppgbjfe Dt Dqphj	Dijon	France
Cqepzy Hksvtunixvx Ev Ucwbvwiobqvps Df Lrosygi	Limoges	France
Atyutzwbxj Pderhlmy Hmozxwct Dr Pcvcq	Paris	France
Celzgi Hcaxozfqmka Rnkicibm Ueepjoceljpiq Dq Tpcio	Tours	France
Gxersa Houlykjqdag Ufqpmoewyvwuo Pehmq Pxqrkwsvfwf Ew Nhretlzcwyvb	Paris	France
Ctkhncgn Ssvle Evjxedy	Toulouse	France
Cip Cmfsk Rkbqefcblfl	Lyon	France
Ippuvolt dd Cbgqhduyogax Hbhghkrjjqb Uvhzatpexzypj dj Swtee Erssqui (felcmqf	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.09.2023

Trial locations

Investigated drugs:

Hydroxychloroquine is a medication that is being tested in this clinical trial to see if it can help reduce the need for steroids in patients with a condition called extra-pulmonary sarcoidosis. This condition affects parts of the body other than the lungs and often requires treatment with steroids, which can have side effects. Hydroxychloroquine is already used to treat other conditions like malaria and certain autoimmune diseases. In this trial, researchers want to find out if adding hydroxychloroquine to the treatment plan can help patients use fewer steroids while still managing their symptoms effectively.

Investigated diseases:

Sarcoidosis

Extrapulmonary Sarcoidosis – Extrapulmonary sarcoidosis is a condition where clusters of inflammatory cells, known as granulomas, form in organs other than the lungs. These granulomas can affect various parts of the body, including the skin, eyes, liver, and lymph nodes. The disease often begins with mild symptoms, such as fatigue and weight loss, and can progress to more specific symptoms depending on the organs involved. For instance, skin involvement may lead to rashes or lesions, while eye involvement can cause vision problems. Over time, the granulomas may cause organ dysfunction if they persist or grow. The progression of the disease varies widely among individuals, with some experiencing only mild symptoms and others facing more significant organ involvement.

Trial ID:

2022-502155-65-00

Protocol code:

69HCL21_1054

NCT ID:

NCT05841758

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Hydroxychloroquine and Prednisone for Patients with Non-Severe Extra-Pulmonary Sarcoidosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?