Safety Study of Efgartigimod in Adults with Primary Sjögren’s Syndrome

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What is this study about?

This clinical trial is focused on studying the safety of a treatment called efgartigimod alfa in adults with Primary Sjögren’s Syndrome. Primary Sjögren’s Syndrome is an autoimmune disease where the body’s immune system mistakenly attacks its own moisture-producing glands, leading to symptoms like dry mouth and dry eyes. The treatment being tested, efgartigimod alfa, is given as a solution through an intravenous infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of this study is to evaluate the long-term safety of efgartigimod alfa in patients who have completed previous studies involving this treatment. Participants will receive the treatment over a period of 48 weeks. During this time, researchers will monitor the participants’ health closely to identify any side effects or changes in their condition. The study will also track various health indicators, such as laboratory test results and vital signs, to ensure the treatment is safe for long-term use.

Throughout the study, participants will have regular check-ups to assess their response to the treatment. The researchers will look for improvements in disease activity and symptoms, as well as any changes in specific markers in the blood. This information will help determine if efgartigimod alfa is a safe and effective option for managing Primary Sjögren’s Syndrome over an extended period.

Who Can Join the Study?

  • You must be at least the legal age of consent, which means you are old enough to legally sign documents and join a medical study.
  • You must be able to provide informed consent, which is a written agreement showing that you understand the study and agree to take part.
  • You must be able to follow all the rules and requirements of the study.
  • If you are a person of childbearing potential, you must have a negative urine pregnancy test before receiving the investigational medicinal product, which is the study drug being tested.
  • You must agree to use contraceptive measures, such as birth control, according to local laws.
  • You must have already finished previous studies testing efgartigimod for Primary Sjögren’s Syndrome and agree to keep taking the study medicine without any breaks.

Who Cannot Join the Study?

  • You have a serious health condition, such as a newly discovered malignancy (cancer) or cardiovascular disease (heart or blood vessel problems).
  • You plan to have surgery (an operation) while the study is ongoing.
  • You have any other medical condition that, in the doctor’s opinion, might make it difficult to see if the study treatment works or might put you at unnecessary danger.
  • You are currently pregnant or are planning to become pregnant during the study.
  • You have any severe systemic manifestations (serious symptoms that affect your entire body) of your condition that the doctor believes could put you at high risk.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Futuremeds Sp. z o.o. Wroclaw Poland
CENTRUM MEDYCZNE REUMA PARK Warsaw Poland
Krakowskie Centrum Medyczne Sp. z o.o. Cracow Poland

Other Sites

Site Name City Country Status
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher Warsaw Poland
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University Of Debrecen Debrecen Hungary
Pratia S.A. Skorzewo Poland
Clinical Research Center Sp. z o.o. Medic-R sp.k. Poznan Poland
Universitair Ziekenhuis Gent Gent Belgium
Vita Verum Medical Bt. Szekesfehervar Hungary
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Reumed Sp. z o.o. Lublin Poland
Ambulatorium Sp. z o.o. Elblag Poland
Mcbk s.c. Iwona Czajkowska Anna Podrazka Szczepaniak Grodzisk Mazowiecki Poland
Centrum Medyczne Amed Sp. z o.o. Warsaw Poland
Mqshjjdgr Ilkxnxnqxx Ctxspmed Sqwdvmni Sko z oloq Warsaw Poland
Erp Leuafd Lublin Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
15.08.2023
Hungary Hungary
Not recruiting
15.08.2023
Poland Poland
Not recruiting
15.08.2023

Trial locations

Investigated drugs:

Efgartigimod is a medication given through a vein as an infusion to help manage symptoms in patients with a condition called primary Sjögren’s syndrome.

Primary Sjögren’s Syndrome – This is an autoimmune condition where the immune system mistakenly attacks the body’s own healthy cells. It primarily targets the glands that produce moisture, such as the salivary and tear glands. As the condition progresses, these glands become inflamed and lose their ability to function properly. This typically leads to persistent dryness in the mouth and eyes. The disease can also involve other parts of the body, such as the joints or internal organs, through ongoing inflammation.

Trial ID:
2023-503915-14-00
Protocol code:
ARGX-113-2211
Trial Phase:
Therapeutic exploratory (Phase II)

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