Ongoing Clinical Trials for Polymyalgia Rheumatica
There are currently 8 clinical trials underway for polymyalgia rheumatica, a condition that causes muscle pain and stiffness, particularly in the shoulders and hips. These studies are testing various medications including secukinumab, rituximab, baricitinib, leflunomide, and SPI-62, with trials taking place across multiple European countries.
Clinical trial locations
- Belgium
- Czechia
- Denmark
- Finland
- France
- Germany
- Hungary
- Iceland
- Ireland
- Italy
- Netherlands
- Study on Leflunomide for Preventing Relapses in Patients with Polymyalgia Rheumatica During Steroid Reduction
- Study on Long-Term Safety of Secukinumab for Patients with Polymyalgia Rheumatica
- Study on Rituximab for Patients with Relapsing Polymyalgia Rheumatica to Reduce Steroid Use
- Study on Rituximab for Reducing Steroid Use in Newly Diagnosed Polymyalgia Rheumatica Patients
- Study on Secukinumab and Prednisone for Patients with Polymyalgia Rheumatica Who Have Recently Relapsed
- Norway
- Poland
- Spain
- Sweden
Study on Long-Term Safety of Secukinumab for Patients with Polymyalgia Rheumatica
This trial focuses on the long-term safety and tolerability of secukinumab, a medication given as an injection under the skin. The study is designed for patients who have previously completed a 52-week treatment period in an earlier study and experienced a return of symptoms during the follow-up period without treatment.
Main inclusion criteria: Participants must have completed a previous 52-week treatment period for polymyalgia rheumatica and experienced a relapse during the treatment-free follow-up period. They should not have received rescue treatment, and the study doctor must judge that the potential benefits outweigh any risks. Both men and women of appropriate age groups can participate.
Main exclusion criteria: Individuals with a different condition, those outside the specified age range, or those considered part of vulnerable populations may not be eligible.
Primary focus: The study monitors any adverse events or serious adverse events that may occur while using secukinumab. Regular assessments will be conducted to ensure participant safety and well-being throughout the study period, which continues until 2028.
Investigational drug: Secukinumab is a biologic medication that works by targeting and inhibiting interleukin-17A, a specific protein in the immune system that plays a role in inflammation.
Study on Rituximab for Patients with Relapsing Polymyalgia Rheumatica to Reduce Steroid Use
This study examines whether rituximab can help reduce the need for glucocorticoids in patients experiencing relapses. The trial compares the effects of rituximab to a placebo, with the medication delivered through an intravenous infusion directly into a vein.
Main inclusion criteria: Participants must have a clinical diagnosis according to 2012 guidelines, symptoms that have returned along with high levels of inflammatory markers in the blood, and be unable to lower their glucocorticoid dose below 5 mg per day. Both men and women aged 18 and older can participate.
Main exclusion criteria: Patients with other serious health conditions that might interfere with the study, those currently in another trial, individuals with past allergic reactions to similar treatments, pregnant or breastfeeding women, those with a history of certain cancers, active infections requiring treatment, or those unable to follow study procedures.
Primary focus: The trial monitors how many patients can achieve remission without glucocorticoids at different time points, such as after one year and two years. It also tracks relapses and any side effects that may occur. The estimated completion date is April 1, 2026.
Investigational drug: Rituximab is a monoclonal antibody that targets and depletes specific immune cells known as B cells, which play a role in the inflammation process.
Study of baricitinib versus placebo for treating polymyalgia rheumatica in adult patients
This trial tests whether baricitinib combined with a short course of glucocorticoids works better than placebo with glucocorticoids in treating the condition. Participants will take the medication orally once daily as film-coated tablets in different doses.
Main inclusion criteria: Participants must be at least 50 years old, have either a new diagnosis or be resistant to previous treatments, either not taking glucocorticoids or taking less than 15 mg per day for at least 15 days, have a disease activity score higher than 17, have no other inflammatory joint conditions, and have French health insurance.
Main exclusion criteria: Age below 50 or above 85 years, current or past giant cell arteritis, previous treatment with disease-modifying drugs, active or recent serious infections, blood clot history or high risk, significant kidney or liver problems, uncontrolled diabetes, current or recent cancer, pregnancy or breastfeeding, planned major surgery, participation in other recent trials, severe heart disease, uncontrolled high blood pressure, history of severe allergic reactions, use of interacting medications, or conditions interfering with assessments.
Primary focus: The main treatment period lasts 24 weeks, monitoring how well the treatment controls disease activity when patients are no longer taking glucocorticoids. Regular checks will evaluate disease activity using various measurements at 12, 24, and 36 weeks.
Investigational drugs: Baricitinib belongs to a class of drugs called JAK inhibitors, which work by decreasing immune system activity to reduce inflammation. Glucocorticoids like prednisone and prednisolone are used as a short-term treatment alongside baricitinib or placebo.
Study of RSV vaccines Arexvy and Abrysvo in patients with inflammatory rheumatic diseases receiving anti-rheumatic treatments
This study evaluates how various treatments for inflammatory rheumatic disease affect the body’s response to respiratory syncytial virus vaccination. Two different RSV vaccines are being tested, both given as a single injection into the muscle.
Main inclusion criteria: Participants must provide written consent, be 60 years or older, be regularly followed at a rheumatology department, and if diagnosed with inflammatory rheumatic disease, be receiving immunomodulating treatment for at least 3 months, including methotrexate, biological treatments, or JAK inhibitors.
Main exclusion criteria: Active respiratory infection, previous severe allergic reactions to vaccines, pregnancy or breastfeeding, current participation in other trials, recent immunoglobulin treatment, immunodeficiency disorders, recent live vaccine administration, uncontrolled chronic conditions, active infection requiring antibiotics, high-dose corticosteroids, known vaccine allergies, history of severe vaccine reactions, active cancer or ongoing treatment, or inability to comply with procedures.
Primary focus: The study determines if medications used to treat inflammatory rheumatic disease affect vaccine effectiveness. Blood samples are taken before and after vaccination to measure immune response, with participants monitored for 3-6 weeks for any side effects.
Investigational products: The trial involves various anti-rheumatic medications including methotrexate, anti-TNF medications, anti-IL6r medications, anti-CD20 medications, and JAK inhibitors, along with two RSV vaccines designed to protect against respiratory syncytial virus.
Study on Leflunomide for Preventing Relapses in Patients with Polymyalgia Rheumatica During Steroid Reduction
This trial investigates whether leflunomide can help prevent symptom relapses in patients who are reducing their use of corticosteroids. The medication is taken orally as a film-coated tablet, and participants receive either leflunomide or a placebo.
Main inclusion criteria: Participants must be 50 years old or older, have polymyalgia rheumatica diagnosed according to 2012 guidelines, and have been recently diagnosed with the condition while taking corticosteroids for less than 4 weeks.
Main exclusion criteria: Patients not diagnosed with the condition, those not within the specified age range, or those considered part of vulnerable populations.
Primary focus: The study monitors how long it takes for a relapse to occur within a 12-month period, aiming to provide information on leflunomide’s effectiveness in maintaining health while tapering off corticosteroids. The trial is expected to conclude by April 1, 2028.
Investigational drug: Leflunomide is a disease-modifying antirheumatic drug that works by inhibiting the synthesis of pyrimidine, essential for immune cell proliferation, thereby reducing inflammation and immune response.
Study of Prednisolone and SPI-62 for Patients with Polymyalgia Rheumatica
This trial studies prednisolone in combination with an investigational medication called Clofutriben, or a placebo, to determine if the dose of prednisolone needs adjustment when used together with Clofutriben.
Main inclusion criteria: Participants must provide written informed consent, have a diagnosis according to specific classification criteria, not have experienced a relapse based on symptoms and markers, and be on a stable daily oral dose of 10 mg of prednisolone for at least one week before baseline, expected to maintain this dose during treatment.
Main exclusion criteria: Patients with other serious health conditions, those taking interfering medications, those having had or planning surgery during the study, pregnant or breastfeeding women, those with allergic reactions to study medication, those unable to follow procedures, recent trial participants, those with drug or alcohol abuse history, those with certain infections, or those with certain mental health conditions.
Primary focus: The study lasts up to 28 days, during which participants take the medications orally in tablet form. Various health markers are monitored, including fibrinogen, C-reactive protein, and oral glucose tolerance tests. The trial aims to conclude by May 31, 2025.
Investigational drugs: Prednisolone is a corticosteroid that works by inhibiting the release of inflammation-causing substances. SPI-62 is an investigational drug being studied for its potential to modulate certain pathways involved in inflammation.
Study on Rituximab for Reducing Steroid Use in Newly Diagnosed Polymyalgia Rheumatica Patients
This study examines the effectiveness of rituximab compared to placebo in newly diagnosed patients, aiming to determine if rituximab can help reduce the need for glucocorticoids. The medication is given as a solution through an intravenous infusion directly into a vein.
Main inclusion criteria: Patients must have newly diagnosed polymyalgia rheumatica within the last 12 weeks, have been on glucocorticoid treatment for less than 8 weeks, and the dose of prednisolone should be less than 30 mg per day. Both men and women can participate.
Main exclusion criteria: Patients with other autoimmune diseases, those previously treated with rituximab or similar medications, those with severe allergic reactions to medications, current clinical trial participants, those with serious infections, history of cancer within the last 5 years (except certain skin cancers), pregnant or breastfeeding women, those with drug or alcohol abuse history, or those with conditions making participation unsafe.
Primary focus: The trial monitors patients to assess their response to treatment, tracking the number who can stop using glucocorticoids without symptom return and overall condition improvement. Regular check-ups track progress and symptom changes, with safety monitored by tracking side effects.
Investigational drug: Rituximab is a monoclonal antibody that works by targeting and reducing certain cells in the immune system involved in inflammation, specifically targeting B cells.
Study on Secukinumab and Prednisone for Patients with Polymyalgia Rheumatica Who Have Recently Relapsed
This trial tests whether secukinumab, when combined with a glucocorticoid taper regimen, is more effective than placebo in helping patients achieve sustained remission. Secukinumab is given as an injection under the skin, while prednisone is taken orally.
Main inclusion criteria: Participants must provide signed informed consent, be at least 50 years old, have a diagnosis based on specific criteria including history of pain in both shoulders and high levels of inflammatory markers, have been treated with prednisone for at least 8 consecutive weeks, have experienced at least one relapse while trying to reduce prednisone to at least 5 mg/day in the last 12 weeks, and be on a prednisone dose between 7.5 mg and 25 mg per day at screening.
Main exclusion criteria: Patients with other serious medical conditions, current trial participants, those with recent infections requiring antibiotics, those with severe allergic reactions to medications, pregnant or breastfeeding women, those with drug or alcohol abuse history, those with cancer in the past five years, those with heart disease or stroke history, uncontrolled high blood pressure, liver or kidney disease, other autoimmune diseases, those who received live vaccines within four weeks, those who had major surgery within eight weeks, or those unable to comply with procedures.
Primary focus: The study lasts up to 52 weeks with participants receiving either secukinumab or placebo along with a tapering dose of prednisone over 24 weeks. The trial is double-blind to ensure unbiased results, with regular check-ups to assess health and treatment effectiveness.
Investigational drugs: Secukinumab is a biologic medication, specifically an interleukin-17A inhibitor, that works by targeting and blocking a specific protein involved in inflammation. Glucocorticoids are used in a plan to slowly decrease the amount taken over 24 weeks to see if patients can maintain remission while reducing reliance on these medications.
Summary
The eight ongoing clinical trials for polymyalgia rheumatica reflect a concentrated effort to find alternatives to long-term glucocorticoid use, which is currently the standard treatment but carries significant side effects. A notable pattern emerges with multiple trials focused on reducing steroid dependence while maintaining disease control.
Several medications are being tested across these trials. Secukinumab appears in three separate studies, including one focused on long-term safety monitoring running until 2028 and another large-scale trial across 15 European countries. Rituximab is being evaluated in two different trials conducted in the Netherlands, both examining its potential to reduce glucocorticoid requirements. Other medications under investigation include baricitinib in France, leflunomide in the Netherlands, and the investigational drug SPI-62 in Poland and Germany.
The trials are predominantly concentrated in Western and Northern Europe. The Netherlands hosts four trials, making it the most active location for polymyalgia rheumatica research. Germany, France, Belgium, Spain, and several Nordic countries also feature prominently. This geographic distribution suggests strong research infrastructure and patient recruitment capabilities in these regions.
One trial stands out for its unique focus: a Swedish study examining how anti-rheumatic treatments affect the immune response to RSV vaccines in patients with inflammatory rheumatic diseases, including polymyalgia rheumatica. This highlights the importance of understanding vaccine effectiveness in patients receiving immunomodulating treatments.
Most trials are expected to conclude between 2025 and 2028, meaning results should become available in the coming years to help guide treatment approaches for this condition.
