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 purpose of the study is to determine if secukinumab can improve shoulder symptoms better than a placebo. Secukinumab is administered as a solution for injection using a pre-filled syringe.

Participants in the study will receive either secukinumab or a placebo. The study will last for 24 weeks, during which the effects of the treatment on shoulder symptoms will be monitored. The main focus will be on changes in physical symptoms related to the shoulder, assessed at different points throughout the study. Participants will be asked to continue any existing treatments, such as non-steroidal anti-inflammatory drugs (NSAIDs) and physiotherapy, at a stable dosage and regimen.

The study will also involve monitoring the safety and tolerability of secukinumab, including any side effects or changes in laboratory results. Participants will have their progress evaluated through various assessments, including the Western Ontario Rotator Cuff Index (WORC) and the Patient-Reported Outcomes Measurement Information System (PROMIS). The study aims to provide valuable insights into the potential benefits of secukinumab for individuals with rotator cuff tendinopathy.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria, such as having moderate to severe rotator cuff tendinopathy for a duration between 6 weeks and 6 months.

You will undergo a physical examination, and your shoulder pain will be assessed. An MRI scan will be conducted to confirm the presence of tendinopathy without significant tears.

2 baseline assessment

At the baseline assessment, your shoulder symptoms will be evaluated using the Western Ontario Rotator Cuff Index (WORC) and a numerical rating scale for pain.

You will be asked to maintain a stable regimen of non-steroidal anti-inflammatory drugs (NSAIDs) and physiotherapy, if applicable, throughout the study.

3 randomization and treatment

You will be randomly assigned to receive either the study medication, secukinumab, or a placebo. This is a double-blind study, meaning neither you nor the study team will know which treatment you are receiving.

If assigned to the secukinumab group, you will receive a 300 mg dose administered subcutaneously (under the skin) at specified intervals.

4 follow-up visits

You will attend follow-up visits at regular intervals, including at weeks 4, 16, and 24. During these visits, your shoulder symptoms and overall health will be monitored.

Blood samples may be taken to measure secukinumab levels and to check for any side effects or the presence of anti-drug antibodies.

5 final assessment

At the end of the 24-week study period, a final assessment will be conducted to evaluate changes in your shoulder symptoms and overall health.

The results will help determine the effectiveness and safety of secukinumab in treating rotator cuff tendinopathy.

Who Can Join the Study?

Must have moderate to severe rotator cuff tendinopathy in one shoulder. This means the shoulder has been painful and difficult to move for at least 6 weeks but not more than 6 months.
Must experience nighttime shoulder pain on at least 3 out of 7 nights in the week before starting the study, or have a positive painful arc test. This is a test where moving the arm in a certain way causes pain.
Must have a Total WORC percentage score of 40 or less at the Screening and Baseline visits. WORC is a questionnaire that measures shoulder problems.
Must have an average weekly pain score of 5 or more on a scale from 0 to 10 during the week before starting the study. This score is based on daily pain ratings.
Must have tried standard treatments like NSAIDs (non-steroidal anti-inflammatory drugs) and physiotherapy for 8 weeks without improvement. NSAIDs are common pain relievers.
Must agree to keep the same dose of NSAIDs and continue physiotherapy from the start of the study until the end, unless the doctor advises otherwise.
Must have tendinopathy in the affected shoulder confirmed by an MRI (Magnetic Resonance Imaging) scan. The MRI should show no tear or only a small tear in the tendon.
Must be within the age range of 18 to 65 years old.
Both male and female participants are eligible.

Who Cannot Join the Study?

Patients with any other shoulder condition that is not related to rotator cuff tendinopathy cannot participate. Rotator cuff tendinopathy is a condition that affects the tendons in the shoulder, causing pain and movement problems.
Patients who have had shoulder surgery in the past 6 months are not eligible.
Patients who are currently receiving treatment with other medications that affect the immune system cannot join the study.
Patients with a history of severe allergic reactions to medications are excluded.
Patients with any active infection or a history of frequent infections are not allowed to participate.
Patients with a history of cancer in the past 5 years, except for certain skin cancers, are excluded.
Patients with severe heart, liver, or kidney problems cannot take part in the study.
Pregnant or breastfeeding women are not eligible to participate.
Patients who are currently participating in another clinical trial are excluded.
Patients with a history of drug or alcohol abuse in the past year cannot join the study.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Mbal Lyulin EAD	Sofia	Bulgaria
H Praxe s.r.o.	Pardubice	Czechia
Ortopedicko-traumatologicka privatni ambulance MUDr. Jan Balik s.r.o.	Kolin	Czechia
Mabi s.r.o.	Prague	Czechia
Orthos Paidion s.r.o.	Bratislava	Slovakia
Sanos A/S	Gandrup	Denmark
Dolnooravska Nemocnica S Poliklinikou Mudr. L. N. Jegeho	Dolny Kubin	Slovakia
Zarmed s.r.o.	Kosice	Slovakia
Centre Hospitalier Universitaire d’Orléans	Orléans	France
Centre Hospitalier Le Mans	Le Mans	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Groupe Hospitalier Diaconesses Croix Saint Simon	Paris	France
University Hospital Bratislava	Bratislava	Slovakia
Artromac N.O.	Kosice	Slovakia
Instituto Portugues De Reumatologia	Lisbon	Portugal
Unidade Local De Saude Do Alto Minho E.P.E.	Ponte De Lima	Portugal
Narodny Ustav Reumatickych Chorob	Piestany	Slovakia
Rijwkojp Igkxheirl Flk Sgnazlv Scmulzz Ajk Tomgcn	Brno	Czechia
Cbrp dh Tyhukc Hcfgxka Tjzuymujp	Chambray Les Tours	France
Icjodfug dv Cbajlzffewpo Hglkncodiuk Uchqgelcelmqa da Sahmq Ebcgqdy (lfupegb	Saint Priest En Jarez	France
Czvfzg Hsnxwlxtcpn Eo Uewsbwmqunvpv Df Lzorfac	Limoges	France
Cvjotg Haadyaqxhra Ubqhnlcmhemrp Da Dcasy	Dijon	France
Mkidzdvcgdum Az	Sofia	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	15.09.2023
Czechia	Not recruiting	15.09.2023
Denmark	Not recruiting	15.09.2023
France	Not recruiting	15.09.2023
Portugal	Not recruiting	15.09.2023
Slovakia	Not recruiting	15.09.2023

Trial locations

Investigated drugs:

Secukinumab

Secukinumab is a medication used in this clinical trial to help improve shoulder symptoms in people with a condition called rotator cuff tendinopathy. This condition causes pain and discomfort in the shoulder due to inflammation or irritation of the tendons. Secukinumab works by targeting a specific protein in the body that is involved in the inflammation process. By reducing inflammation, it can help relieve pain and improve shoulder function. This medication is given as an injection under the skin.

Rotator Cuff Tendinopathy – Rotator cuff tendinopathy is a condition affecting the tendons of the rotator cuff in the shoulder. It is characterized by pain and inflammation in the shoulder area, often resulting from overuse or repetitive motion. The condition progresses as the tendons become more irritated and inflamed, leading to increased pain and reduced range of motion. Over time, the tendons may weaken, causing difficulty in performing everyday activities that involve shoulder movement. In more severe cases, the tendons can degenerate, leading to chronic pain and further restriction of shoulder function.

Trial ID:

2022-502068-19-00

Protocol code:

CAIN457O12301

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?