Rotator-cuff tendinopathy shoulder pain
Conditions
Interventions
Group 1: Secukinumab 300 mg s.c. (2 x 150 mg)
Group 2: Placebo s.c. (2 injections)
Sponsors
Novartis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study must fulfill all of the following criteria: * Written informed consent obtained prior to all study specific screening procedures, as close to the start of the screening period as possible * Male or non-pregnant, non-lactating female patients 18 to 65 years of age at randomization * Presence of unilateral rotator cuff tendinopathy with: a. Symptoms present *6 weeks, but
Exclusion criteria
Exclusion criteria: * History of hypersensitivity to any of the study treatments or excipients or to drugs of similar chemical classes * Rheumatologic, inflammatory diseases, including but not limited to: PsA, AS and RA * Previous shoulder surgery in affected shoulder * History of adhesive capsulitis/frozen shoulder or calcification in the tendon (in affected or contralateral shoulder) confirmed by X-Ray, historic X-Rays can be used if performed within 3 months of baseline * Symptomatic osteoarthritis of the shoulder (gleno-humeral, acromioclavicular) (in affected or contralateral shoulder confirmed by X-Ray, historic X-Rays can be used if performed within 3 months of baseline * Neck conditions, including but not limited to cervical spine syndrome, which in the opinion of the investigator, may explain the patient*s symptoms * Previous platelet rich plasma injections within the last 12 months prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Western Ontario Rotator Cuff (WORC) patient reported outcome (PRO) score at week 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| * WORC score at Weeks 2, 4, 8, 12, 18 and 24 * Disability of Arm, Shoulder and Hand Questionnaire (QuickDASH) score at Weeks 2, 4, 8, 12, 14, 18 and 24 * American Shoulder and Elbow Surgeons Shoulder Evaluation Form (ASES) score at Weeks 2, 4, 8, 12, 14, 18 and 24 * EQ5D-3L score at Weeks 2, 4, 8, 12, 14, 18 and 24 * Pain score using a VAS scale (considering the last 24 hours) at Weeks 2, 4, 8, 12, 14, 18 and 24 * Patient global assessment (PGA) score using a VAS scale (considering the last 24 hours), at Weeks 2, 4, 8, 12, 14, 18 and 24 * Physician global assessment (PhGA) score using a VAS scale (considering the last 24 hours), at Weeks 2, 4, 8, 12, 14, 18 and 24 * MRI Sein score at Weeks 8, 14 and 24 * PK/immunogenicity assessment at Day 1, Weeks 4, 12, 24 * Safety and tolerability assessments over time: Incidence and severity of AEs and SAEs; routine safety laboratory parameters | — |
Countries
Netherlands
Outcome results
None listed