Rotator cuff tendinopathy MedDRA version: 20.1 Level: LLT Classification code 10080130 Term: Tendinopathy System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Secukinumab
CAS Number: 1229022-83-6
Current
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants eligible for inclusion in this study must fulfill all of the following criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Males and non-pregnant, non-nursing females between 18 and 65 years of age 3. Rotator cuff tendinopathy (unilateral) with positive “Painful Arc Test” on examination 4. Symptoms present for at least 6 weeks but not more than 6 months at Baseline 5. Moderate to severe rotator cuff tendinopathy demonstrated by all of the following criteria: a. WORC score = 40 at Baseline b. NRS pain score = 5 at Baseline and at least 3 days of the past 7 days prior to Baseline c. Nocturnal pain at least 4 out of past 7 days in the week prior to Baseline 6. Failure to at least 8 weeks of conventional therapy prior to Baseline: inadequate response to NSAIDs and/or paracetamol and physiotherapy; or intolerance to NSAIDs and/or paracetamol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 410 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Participants fulfilling any of the following criteria are not eligible for inclusion in this study. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible participants. 1. Greater than 50% partial thickness tear as established by MRI or ultrasound during assessment in Run-in phase 2. Patients who are expected to require glucocorticoid treatment throughout the trial duration at Baseline (e.g., systemic, intramuscular, local injections in shoulder) 3. Previous surgery, or plans for surgery, during the study period, in the affected shoulder 4. Rheumatologic and chronic inflammatory diseases, including but not limited to inflammatory bowel disease, polymyalgia rheumatica (PMR), PsA, axSpA and rheumatoid arthritis (RA), fibromyalgia or severe pain disorder unrelated to the target shoulder 5. Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies positive at Screening 6. History of adhesive capsulitis/frozen shoulder or calcification in the tendon (in affected or contralateral shoulder) confirmed clinically or by medical imaging 7. Symptomatic osteoarthritis of the shoulder (glenohumeral, acromioclavicular) in affected or contralateral shoulder confirmed by medical imaging 8. Patients with traumatic rupture that would be considered eligible for surgery for repair of cuff tear. 9. Neurological conditions including but not limited to cervical radiculopathy, which in the opinion of the investigator may explain the patient’s symptoms 10. Any intra-articular/subacromial glucocorticoid treatment within 12 weeks prior to Baseline or more than 2 injections for the current tendinopathy. 11. Any oral, intramuscular or i.v. glucocorticoid treatment 12 weeks prior to Baseline or during the current tendinopathy, whichever takes longer 12. Previous platelet rich plasma (PRP) injections or fluroquinolone/quinolone antibiotics within 12 weeks prior to Baseline or during the current tendinopathy, whichever takes longer 13. Neuromuscular or primary/secondary muscular deficiency which limits the ability to perform functional measurement (e.g., shoulder strength test) 14. Previous hyaluronic injections within 12 weeks prior to Baseline or during the current tendinopathy, whichever takes longer Other protocol-defined exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To demonstrate the superiority of 12 weeks of treatment with secukinumab 300 mg s.c. compared to placebo (both arms in combination with patient individualized conventional therapy), in participants with moderate to severe rotator cuff tendinopathy, based on change in Western Ontario Rotator Cuff index (WORC) score from Baseline to week 24.;Secondary Objective: • To demonstrate the superiority of secukinumab 300 mg s.c. compared to placebo (both arms in combination with patient individualized conventional therapy), in participants with moderate to severe rotator cuff tendinopathy on signs and symptoms as well as activities of daily living and quality of life. • To evaluate the safety and tolerability of secukinumab in participants with moderate to severe rotator cuff tendinopathy.;Primary end point(s): • Mean change in WORC patient reported outcome (PRO) score from Baseline to week 24 ;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Mean change in WORC score in each subdomain from Baseline to week 24 • Mean change in Patient global assessment (PaGA) score using a VAS (considering the last 24 hours) from Baseline to week 24 • Mean change in SF-36 survey (including all subscales and component summary scores) from Baseline to week 24 • QuickDASH score from Baseline to week 24 • Mean change in Pain score using a NRS (considering the last 24 hours) from Baseline to week 24 • Mean change in EQ-5D-5L health related question (VAS) from Baseline to week 24 • Number and proportion of participants with adverse events (AEs), serious adverse events (SAEs) (incidence, severity, and relationship with study drug) as well as description of clinically laboratory parameters and vital signs ;Timepoint(s) of evaluation of this end point: Week 24 / Ongoing | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed