Study on the Safety and Effectiveness of Upadacitinib and Prednisolone in Patients with Giant Cell Arteritis

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What is this study about?

This clinical trial is focused on studying the condition known as Giant Cell Arteritis, a disease that causes inflammation of the blood vessels, often in the head. The study is evaluating the safety and effectiveness of a medication called Upadacitinib, which is a type of drug known as a Janus Kinase (Jak-1) inhibitor. This medication is being tested in combination with a corticosteroid taper regimen, which involves gradually reducing the dose of corticosteroids, a type of medication that helps reduce inflammation.

The purpose of the study is to determine how well Upadacitinib works in helping patients achieve sustained remission, meaning the disease symptoms are kept under control, over a period of 52 weeks. Participants in the study will receive either Upadacitinib or a placebo, which is a substance with no active medication, alongside their corticosteroid treatment. The study will monitor the participants’ health and any changes in their condition throughout the trial period.

During the study, participants will take the medication orally in the form of tablets. The trial will last for up to 104 weeks, with regular check-ups to assess the safety and tolerability of the treatment. The study aims to provide valuable information on the potential benefits of Upadacitinib for individuals with Giant Cell Arteritis, helping to improve treatment options for this condition.

1 joining the study

Upon joining the study, the patient is confirmed to have a diagnosis of Giant Cell Arteritis (GCA) and meets the inclusion criteria, such as being at least 50 years old and having active GCA within 8 weeks of study start.

2 initial treatment phase

The patient begins treatment with a corticosteroid regimen, specifically prednisolone, taken orally. The dosage starts at 20 mg per day or higher, depending on prior treatment history.

3 randomization and medication administration

The patient is randomly assigned to receive either upadacitinib or a placebo. Upadacitinib is administered as a modified-release tablet taken orally. The exact dosage and frequency are determined by the study protocol.

4 monitoring and assessment

Throughout the study, the patient’s health is monitored regularly to assess the safety and efficacy of the treatment. This includes checking for signs and symptoms of GCA and measuring inflammation markers like ESR and CRP.

5 corticosteroid tapering

The patient follows a protocol-defined corticosteroid taper regimen, gradually reducing the dosage of prednisolone over time, as long as the disease remains stable.

6 evaluation of sustained remission

The primary goal is to achieve sustained remission by Week 52, defined as the absence of GCA signs and symptoms and adherence to the corticosteroid taper regimen.

7 completion of the study

At the end of the study period, the patient’s overall health and treatment outcomes are evaluated. This includes assessing the number of disease flares, changes in quality of life, and satisfaction with the treatment.

Who Can Join the Study?

You must have a diagnosis of Giant Cell Arteritis (GCA). This is a condition that affects the blood vessels.
You need to be an adult, at least 50 years old.
You should have a history of certain blood test results: ESR (a test that checks for inflammation) of 50 mm/hour or higher, or CRP (another inflammation test) of 1.0 mg/dL or higher.
You must have clear symptoms of GCA, such as headaches or jaw pain, or symptoms of Polymyalgia Rheumatica (PMR), which can cause muscle pain and stiffness.
You need to have one of the following: a temporal artery biopsy showing signs of GCA, or imaging tests like MRI, CT, or PET scans showing large vessel inflammation, or an ultrasound of the temporal arteries.
Your GCA must be active, either newly diagnosed or having a flare-up, within 8 weeks before starting the study.
You should have been treated with at least 40 mg of prednisone (a type of steroid) at any time before the study and be taking at least 20 mg daily at the start of the study.
Your GCA should be stable, meaning it is not getting worse.
If you are a female, you must be either postmenopausal, permanently surgically sterile, or using at least one specified method of birth control during the study.

Who Cannot Join the Study?

Patients who have a history of severe allergic reactions to the study medication or similar drugs.
Patients with other serious health conditions that could interfere with the study, such as uncontrolled diabetes or heart disease.
Patients who are currently participating in another clinical trial.
Patients who are pregnant or breastfeeding.
Patients who have had a recent infection that required treatment with antibiotics.
Patients with a history of drug or alcohol abuse.
Patients who have received certain medications that could affect the study results within a specific time frame before the study starts.
Patients who have been diagnosed with certain types of cancer.
Patients who have a history of mental health conditions that are not well controlled.
Patients who have had a recent surgery or are planning to have surgery during the study period.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
Zuyderland Medisch Centrum Stichting	Geleen	The Netherlands
Frisius	Heerenveen	The Netherlands
Sydvestjysk Sygehus	Esbjerg	Denmark
Oncopole Claudius Regaud	Toulouse	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Hospital Universitario Basurto	Bilbao	Spain
Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz	Budapest	Hungary
Ziekenhuisgroep Twente Stichting	Almelo	The Netherlands
University Of Skane	Malmo	Sweden
Hippokration Hospital	Athens	Greece
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
Unidade Local De Saude Da Guarda E.P.E.	Guarda	Portugal
Hospital Universitario De Canarias	La Laguna	Spain
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Hhhillcr Ubzfzirqlaaqp Mktccwx Dw Vjxcxbhcvf	Santander	Spain
Ugqutrwyfvmqsiejdlytm Wxataylfh Azg	Wuerzburg	Germany
Fvltjahrk Pznq Ln Itxyxstyphbvk Bwxcewarl Dfb Hfkjhdtx Ufxvwnwwgfisu Lw Pqo	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.02.2019
Denmark	Not recruiting	01.02.2019
France	Not recruiting	01.02.2019
Germany	Not recruiting	01.02.2019
Greece	Not recruiting	01.02.2019
Hungary	Not recruiting	01.02.2019
Portugal	Not recruiting	01.02.2019
Spain	Not recruiting	01.02.2019
Sweden	Not recruiting	01.02.2019
The Netherlands	Not recruiting	01.02.2019

Trial locations

Investigated drugs:

Upadacitinib: This medication is being studied for its effectiveness in treating Giant Cell Arteritis, a condition that causes inflammation of the blood vessels. The trial aims to see if Upadacitinib can help patients achieve sustained remission when used alongside a corticosteroid taper regimen. The study also evaluates the safety and tolerability of Upadacitinib for patients with this condition.

Investigated diseases:

Giant cell arteritis

Giant Cell Arteritis – This is an inflammatory disease affecting the large and medium-sized arteries, primarily in the head. It often causes headaches, scalp tenderness, jaw pain, and vision problems. The inflammation can lead to narrowing or blockage of the affected arteries, reducing blood flow. Over time, this can result in complications such as vision loss or stroke if not managed. The disease is more common in older adults, particularly those over 50 years of age. Symptoms may fluctuate, with periods of flare-ups and remission.

Trial ID:

2023-505476-29-00

Protocol code:

M16-852

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Effectiveness of Upadacitinib and Prednisolone in Patients with Giant Cell Arteritis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?