Study of Efficacy and Safety of AIN457/Secukinumab in Patients With Rotator Cuff Tendinopathy

Inclusion Criteria

• Signed informed consent had to be obtained prior to participation in the study.
• Males and non-pregnant, non-nursing females were between 18 and 65 years of age.
• Rotator cuff tendinopathy (unilateral) was present with a positive "Painful Arc Test" on examination.
• Symptoms had been present for at least 6 weeks but not more than 6 months at Baseline.
• Moderate to severe rotator cuff tendinopathy was demonstrated by all of the following criteria:
• WORC score was ≤ 40 at Baseline.
• NRS pain score was ≥ 5 at Baseline and for at least 3 days of the 7 days prior to Baseline.
• Nocturnal pain occurred at least 4 out of the 7 days in the week prior to Baseline.
• Patients had failed 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.

Exclusion Criteria

• Greater than 50% partial thickness tear had been established by MRI or ultrasound during assessment in the Run-in phase.
• Patients were expected to require glucocorticoid treatment throughout the trial duration at Baseline (e.g., systemic, intramuscular, local injections in shoulder).
• Previous surgery, or plans for surgery, during the study period, in the affected shoulder.
• 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.
• Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies were positive at Screening.
• History of adhesive capsulitis/frozen shoulder or calcification in the tendon (in affected or contralateral shoulder) had been confirmed clinically or by medical imaging.
• Symptomatic osteoarthritis of the shoulder (glenohumeral, acromioclavicular) in affected or contralateral shoulder had been confirmed by medical imaging.
• Patients had traumatic rupture that would have been considered eligible for surgery for repair of cuff tear.
• Neurological conditions including but not limited to cervical radiculopathy, which in the opinion of the investigator could have explained the patient's symptoms.
• Any intra-articular/subacromial glucocorticoid treatment had occurred within 12 weeks prior to Baseline or more than 2 injections for the current tendinopathy.
• Any oral, intramuscular or i.v. glucocorticoid treatment had occurred 12 weeks prior to Baseline or during the current tendinopathy, whichever was longer.
• Previous platelet rich plasma (PRP) injections or fluoroquinolone/quinolone antibiotics had occurred within 12 weeks prior to Baseline or during the current tendinopathy, whichever was longer.
• Neuromuscular or primary/secondary muscular deficiency had limited the ability to perform functional measurement (e.g., shoulder strength test).
• Previous hyaluronic injections had occurred within 12 weeks prior to Baseline or during the current tendinopathy, whichever was longer.