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Study on the Effectiveness and Safety of Secukinumab for Adults with Moderate to Severe Rotator Cuff Tendinopathy

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What is this study about?

This clinical trial is focused on studying the effects of a medication called secukinumab on individuals with moderate to severe rotator cuff tendinopathy. Rotator cuff tendinopathy is a condition that affects the shoulder, causing pain and difficulty in movement. The study aims to determine if secukinumab, given as an injection under the skin, is more effective than a placebo in improving shoulder symptoms over a period of 16 weeks.

Participants in the study will receive either secukinumab or a placebo. Secukinumab is a solution for injection that is administered using a pre-filled syringe. The study will last for 24 weeks, during which participants will be monitored for changes in their shoulder symptoms. The main goal is to see if secukinumab can significantly improve physical symptoms compared to the placebo. The study will also assess the safety and tolerability of secukinumab by monitoring any side effects or changes in health indicators.

Throughout the study, participants will have regular check-ups to track their progress and any changes in their condition. The study will also involve the use of MRI scans to confirm the presence of tendinopathy in the shoulder. The results will help determine the effectiveness of secukinumab in treating moderate to severe rotator cuff tendinopathy and provide valuable information on its safety for patients.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, such as having moderate to severe rotator cuff tendinopathy for a duration between 6 weeks and 6 months.

Participants must have experienced shoulder pain at night on at least 3 out of 7 nights before the baseline visit or have a positive painful arc test.

An MRI is conducted to confirm the presence of tendinopathy without significant tears.

2 baseline assessment

A baseline assessment is conducted to evaluate the initial condition using the Western Ontario Rotator Cuff Index (WORC) and other measures.

Participants are required to maintain a stable regimen of NSAIDs and physiotherapy from this point until the end of the study.

3 treatment phase

Participants receive either secukinumab or a placebo. Secukinumab is administered as a 300 mg subcutaneous injection.

The treatment is given at specified intervals, with serum concentrations measured on Day 1 and Weeks 4 and 16.

4 mid-study evaluation

At Week 16, the primary endpoint is assessed by measuring changes in the WORC Physical Symptom Domain score.

Secondary endpoints include improvements in other scores and the safety and tolerability of the treatment.

5 end of study evaluation

At Week 24, further assessments are conducted to evaluate long-term improvements in shoulder symptoms.

The study concludes with a final evaluation of safety, including any adverse effects and changes in laboratory parameters.

Who Can Join the Study?

  • Have moderate to severe rotator cuff tendinopathy in one shoulder, with symptoms lasting between 6 weeks and 6 months.
  • Experience nighttime shoulder pain on at least 3 out of 7 nights in the week before the study starts, or have a positive painful arc test during a physical exam. A painful arc test is a way to check for shoulder pain when lifting the arm.
  • Have a WORC percentage score of 40 or less at the screening and start of the study. WORC is a questionnaire that measures shoulder problems.
  • Have an average pain score of 5 or more over the past 7 days before the study starts, based on a scale where you rate your pain each day.
  • Have tried standard treatments like NSAIDs (non-steroidal anti-inflammatory drugs) and physiotherapy for 8 weeks, but still have symptoms. NSAIDs are common pain relievers.
  • Agree to keep the same dose of NSAIDs and continue physiotherapy from the start of the study until the end, unless you can’t tolerate them or they are not recommended for you. You can reduce the NSAID dose but not increase it.
  • Have tendinopathy in the affected shoulder confirmed by an MRI (Magnetic Resonance Imaging) scan, with no tear or only a partial tear of the tendon. A partial tear means the tendon is damaged but not completely torn, with a maximum of 50% thickness affected and a length of up to 10 mm.
  • Be within the age range specified for the study.
  • Both male and female participants are eligible.
  • Participants from vulnerable populations can also join the study.

Who Cannot Join the Study?

  • Participants with any other shoulder condition that could interfere with the study results.
  • Individuals who have had recent shoulder surgery or plan to have shoulder surgery during the study period.
  • People with a history of allergic reactions to the study medication or similar medications.
  • Participants who are currently using other treatments that could affect the study outcomes.
  • Individuals with severe health conditions that could make participation unsafe.
  • Pregnant or breastfeeding women.
  • Participants who are unable to follow the study procedures or attend study visits.
  • Individuals with a history of drug or alcohol abuse that could interfere with the study.
  • People who have participated in another clinical trial recently.
  • Participants with certain infections or immune system disorders.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
InterHem Poradnie Specjalistyczne Bialystok Poland
Indywidualna Praktyka Lekarska Lekarz Paweł Bazela Elblag Poland
Kat Attica General Hospital Kifissia Greece

Other Sites

Site Name City Country Status
General University Hospital Of Larissa Larissa Greece
Sanos A/S Gandrup Denmark
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j. Piotrkow Trybunalski Poland
Azienda Ospedaliera Sant Anna E San Sebastiano Di Caserta Caserta Italy
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti Chieti Italy
Revita Kft. Budapest Hungary
Etg Neuroscience Sp. z o.o. Warsaw Poland
University Of Debrecen Debrecen Hungary
Universita’ Politecnica Delle Marche Ancona Italy
Istituto Ortopedico Rizzoli Bologna Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Ospedale Galeazzi S.p.A. Milan Italy
Dc-Med Michal Kowalski sp.k. Swidnica Poland
Azienda Sociosanitaria 3 Genoa Italy
Hospital Hm Rosaleda Hm La Esperanza Santiago De Compostela Spain
University Of L’Aquila L'aquila Italy
Athens Medical Center S.A. Athens Greece
DRC Kft. Szekesfehervar Hungary
Mnjetsfbk Intjnhaumc Ccwqsrdz Soojsfwb Sym z ofek Warsaw Poland
Puvx Tklmu Hpdipwyc Uvkflbrtxktv Sabadell Spain
Adcdarr Omsaodpqfmu Uydunsaihlewp Smffen Siena Italy
Cwwbtgh Mvbwhfpm Sgrofn Ffyztu Cracow Poland
Huavsoxd Udlotdyzdsama dc A Cfupjo A Coruna Galicia Spain

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

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
15.09.2023
Greece Greece
Not recruiting
15.09.2023
Hungary Hungary
Not recruiting
15.09.2023
Italy Italy
Not recruiting
15.09.2023
Poland Poland
Not recruiting
15.09.2023
Spain Spain
Not recruiting
15.09.2023

Trial locations

Investigated drugs:

Secukinumab is a medication used in this clinical trial to treat patients with active rotator cuff tendinopathy. It is designed to help reduce inflammation and improve physical shoulder symptoms in individuals with moderate to severe conditions. The trial aims to demonstrate that secukinumab is more effective than a placebo in improving these symptoms over a period of 16 weeks.

Rotator Cuff Tendinopathy – This condition involves inflammation or irritation of the tendons in the shoulder’s rotator cuff. It typically results from repetitive overhead activities or acute injury, leading to pain and weakness in the shoulder. As the condition progresses, individuals may experience increased discomfort during shoulder movements, especially when lifting the arm. Over time, the tendons may become more damaged, potentially leading to partial or complete tears. The severity of symptoms can vary, with some people experiencing mild discomfort and others facing significant pain and limited shoulder function. Regular activities such as reaching, lifting, or sleeping on the affected side may become challenging.

Trial ID:
2022-502080-38-00
Protocol code:
CAIN457O12302
Trial Phase:
Therapeutic confirmatory (Phase III)

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