Study of Prednisolone and SPI-62 for Patients with Polymyalgia Rheumatica

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What is this study about?

This clinical trial is focused on studying the treatment of Polymyalgia Rheumatica (PMR), a condition that causes muscle pain and stiffness, especially in the shoulders. The study involves the use of a medication called prednisolone, which is commonly used to reduce inflammation and relieve symptoms in PMR patients. In this trial, prednisolone is being tested in combination with another medication known as Clofutriben (SPI-62), or a placebo, to see if the combination can provide effective treatment for PMR.

The purpose of the study is to determine if the dose of prednisolone needs to be adjusted when it is used together with Clofutriben to achieve the same level of effectiveness. Participants in the study will take either prednisolone with Clofutriben or prednisolone with a placebo. The study will last for a period of up to 28 days, during which participants will take the medications orally in the form of tablets. The trial aims to gather information on how these medications work together and whether any changes in dosage are necessary.

Throughout the study, various health markers will be monitored, such as levels of fibrinogen, a protein involved in blood clotting, and C-reactive protein, which is a marker of inflammation in the body. Additionally, tests like the oral glucose tolerance test will be conducted to assess how the body processes sugar. The study is expected to provide valuable insights into the treatment of PMR and help improve the management of this condition.

1 joining the study

Upon joining the study, the participant must provide written informed consent.

The participant must have a diagnosis of polymyalgia rheumatica (PMR) according to specific classification criteria.

The participant should not have experienced a PMR relapse based on symptoms and specific markers.

The participant must be on a stable daily oral dose of 10 mg of prednisolone for at least one week before the baseline visit and is expected to maintain this dose during the treatment period.

2 baseline visit

The baseline visit involves confirming the participant’s eligibility and ensuring the stability of the prednisolone dose.

Initial assessments and measurements are conducted to establish a starting point for the trial.

3 treatment phase

Participants will receive either SPI-62 or a placebo in combination with their stable dose of prednisolone.

The SPI-62 is administered orally in the form of film-coated tablets.

The prednisolone is administered orally in the form of tablets, with a dosage of 5 mg.

The objective is to determine if a dose adjustment of prednisolone is necessary when administered with SPI-62.

4 monitoring and assessments

Throughout the trial, participants will undergo regular monitoring and assessments.

Primary endpoints include measurements of fibrinogen, erythrocyte sedimentation ratio, and C-reactive protein.

Secondary endpoints include an oral glucose tolerance test, osteocalcin levels, and urinary 11β-hydroxysteroid dehydrogenase type 1 ratio.

5 completion of the trial

The trial is expected to conclude by May 31, 2025.

Final assessments will be conducted to evaluate the outcomes and effectiveness of the treatment.

Who Can Join the Study?

Provide written informed consent, which means you agree to participate in the study after being fully informed about it.
Have a diagnosis of Polymyalgia Rheumatica (PMR) according to specific medical guidelines known as EULAR/ACR classification criteria.
Currently not experiencing a PMR relapse, meaning your symptoms are stable and not worsening, as confirmed by certain medical tests.
Be taking a daily oral dose of prednisolone at 10 mg, which is a type of medication, and this dose should have been stable for at least one week before starting the study and is expected to stay the same during the study.
Both men and women can participate in the study.
The study includes individuals from a vulnerable population, which means people who might need special protection or consideration.

Who Cannot Join the Study?

Patients who have any other serious health conditions that could interfere with the study.
Patients who are currently taking medications that might affect the study results.
Patients who have had a recent surgery or are planning to have surgery during the study period.
Patients who are pregnant or breastfeeding.
Patients who have a history of allergic reactions to the study medication or similar drugs.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who have participated in another clinical trial recently.
Patients with a history of drug or alcohol abuse.
Patients who have certain infections that could affect the study.
Patients with a history of certain mental health conditions that could interfere with the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Praxis für Rheumatologie, Gastroenterologie und Innere Medizin	Munich	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany

Other Sites

Site Name	City	Country
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH	Hamburg	Germany
Dolnoslaski Szpital Specjalistyczny Im. T.Marciniaka-Centrum Medycyny Ratunkowej	Wroclaw	Poland
Charite Research Organisation GmbH	Berlin	Germany
Nova Reuma Domyslawska I Rusilowicz Lekarza Reumatologa I Fizjoterapeuty sp.p.	Bialystok	Poland
Unspwpprojcabjavbmrf dor Rzmnnvvwuukaofdw Bysxnz	Herne	Germany
Ibkelgmvclmehu Pheinkwxfsaaswjdph Rdxiupatqucsl	Erlangen	Germany
Oeywxzx Bnnxh Kppaqtehjdu Wdtvlhewn For	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	26.08.2022
Poland	Not recruiting	26.08.2022

Trial locations

Investigated drugs:

Prednisolone is a medication used to reduce inflammation in the body. It is commonly prescribed for conditions like polymyalgia rheumatica (PMR) to help relieve symptoms such as pain and stiffness. In this trial, prednisolone is being used to see if its dose needs to be adjusted when taken with another medication.

SPI-62 is an investigational drug being studied for its potential to work alongside prednisolone in treating polymyalgia rheumatica (PMR). The trial aims to determine if SPI-62 can help manage PMR symptoms effectively and whether it affects the required dose of prednisolone.

Investigated diseases:

Polymyalgia rheumatica

Polymyalgia Rheumatica – Polymyalgia rheumatica is an inflammatory disorder that primarily affects older adults, causing muscle pain and stiffness, especially in the shoulders and hips. The symptoms often appear suddenly and are more severe in the morning or after periods of inactivity. The exact cause of the condition is unknown, but it is believed to involve immune system abnormalities. It is often associated with an elevated erythrocyte sedimentation rate and C-reactive protein levels, indicating inflammation. The condition can lead to significant discomfort and reduced range of motion, impacting daily activities. While it can be persistent, symptoms may fluctuate over time.

Trial ID:

2024-517406-29-00

Protocol code:

SPI-62-CL-2003

NCT ID:

NCT05436652

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Prednisolone and SPI-62 for Patients with Polymyalgia Rheumatica

What is this study about?

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