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

Novartis Pharmaceuticals62 enrolled

Overview

The purpose of this study was to investigate the efficacy and safety of secukinumab subcutaneously (s.c.) compared to placebo in adult patients with moderate to severe rotator cuff tendinopathy and failure to conventional therapy.

This was a randomized, double-blind, placebo-controlled, parallel-group, multicenter, Phase IIIb, 24-week study to investigate the superior efficacy of secukinumab and safety in participants with rotator cuff tendinopathy. Secukinumab 300 mg s.c. was compared to placebo (both arms in combination with patient individualized conventional therapy) in relieving clinical symptoms at Week 24. The study consisted of a screening period up to 6 weeks, a 2-week run-in period, a 12-week treatment period and a 12-week follow-up period. Treatment and follow-up periods were blinded. Participants who met the eligibility criteria at screening continued to the run-in period and were randomized. In the run-in period, participants performed 2 weeks of home-based standardized physiotherapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Tendinopathy

Interventions

SecukinumabDRUG

Secukinumab 300 mg s.c for 12 weeks in a pre-filled syringe (PFS)

PlaceboOTHER

Placebo to match secukinumab s.c. for 12 weeks in a PFS

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: 1. WORC score was ≤ 40 at Baseline. 2. NRS pain score was ≥ 5 at Baseline and for at least 3 days of the 7 days prior to Baseline. 3. 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.

Locations (19)

Novartis Investigative Site

Karlsruhe, Baden-Wurttemberg, Germany

Novartis Investigative Site

Munich, Bavaria, Germany

Outcomes

Primary Outcomes

Change From Baseline in the Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Percentage Score at Week 24

The WORC Index consisted of 21 items divided into 5 Domains: Physical Symptoms (6 items), Sport/Recreation (4 items), Work Function (4 items), Lifestyle Function (4 items) and Emotional Function (3 items). Each of the 21 items in the WORC was rated using a visual analogue scale (VAS) ranging from 0 (no impact on quality of life) to 100 (worst possible impact). Thus, the total score ranged from 0 to 2100 points. The score was reported as a percentage of normal by subtracting the total score from 2100, dividing by 2100, and multiplying by 100. Total final WORC percentage scores ranged from 0%, the lowest functional status level, to 100%, the highest functional status level. Change from baseline in the WORC percentage total score was assessed at Week 24. A positive change from baseline indicated an improvement.

Time frame: Baseline, Week 24

Secondary Outcomes

Change From Baseline in the WORC Percentage Sub-scores at Week 24

The WORC Index consisted of 21 items divided into 5 Domains: Physical Symptoms (6 items), Sport/Recreation (4 items), Work Function (4 items), Lifestyle Function (4 items) and Emotional Function (3 items). Each of the 21 items in the WORC was rated using a VAS ranging from 0 (no impact on quality of life) to 100 (worst possible impact). Each subdomain score was calculated as a percentage of normal function, ranging from 0% (worst condition) to 100% (best condition). Change from baseline in the WORC Index percentage sub-domain score was assessed at Week 24. A positive change from baseline indicated an improvement

Time frame: Baseline, Week 24

Change From Baseline in Participant's Global Assessment of Disease Activity Score at Week 24

The participant's global assessment of disease activity was performed using 100 mm VAS ranging from 0="no activity" to 100= "most active", after the question " Please indicate with a vertical mark ( \| ) through the horizontal line the global activity of your disease in the last 24 hours". Change from baseline in the participant's global assessment of disease activity score was assessed at Week 24. A negative change from baseline indicated improvement

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.