A randomized, parallel-group, 24 week, double-blind, placebo-controlled, multicenter Phase 3 study to assess the efficacy and safety of secukinumab compared to placebo in adult patients with active rotator cuff tendinopathy.

Date Added
September 12th, 2023
PRO Number
Pro00128912
Researcher
Josef Eichinger

List of Studies


Keywords
Drug Studies, Joint, Muscle, Pain
Summary

Patients greater than/equal to 18 years of age who are diagnosed with unilateral rotator cuff tendinopathy (with MRI confirmation) will be recruited. The purpose of the study is to measure the safety and efficacy of the drug secukinumab, 300mg s.c. (subcutaneous) compared to placebo. The use of secukinumab for the treatment of tendinopathy is investigational in this study, but FDA approved for other indications. The study will be a randomized, double-blind study. This means the participant, nor the researchers will know if the drug or placebo is administered. The treatment period will last 16 weeks, during which the patient will receive 7 doses of the study drug (2 injections per dose) over 12 weeks. Participants will continue follow-up until week 24. A total of 11 visits are required for the study, each will take approximately 3 hours to complete. These visits will be at the following timepoints: Screening visit, Baseline visit, and visits at weeks 1,2,3,4,8,12,16, 20, and the end of the study visit. The location of the injection will be the affected shoulder.

Risks include but are not limited to upper respiratory tract infections, with symptoms such as sore throat and stuffy nose. Common risks include Cold sores, Athletes foot, runny nose, diarrhea, itchy rash (urticaria). Rare and serious risks include Severe allergic reaction with shock (anaphylactic reactions). A blood draw may cause fainting, pain, and/or bruising, dizziness, and in rare cases, infection.

Institution
MUSC
Recruitment Contact
Maggie Schiessl
843-792-7534
schiessl@musc.edu

Operative versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears: A Multicenter Randomized Controlled Pragmatic Trial

Date Added
October 7th, 2019
PRO Number
Pro00088804
Researcher
Josef Eichinger

List of Studies


Keywords
Bone, Joint, Physical Therapy, Surgery
Summary

Patients of age ≥40 to <85 years diagnosed with a rotator cuff tear (with MRI confirmation) who are fit for either arthroscopic rotator cuff surgery or physical therapy will be recruited. The study will compare pain and function in patients undergoing operative versus non-operative treatment of Non traumatic rotator cuff tears at 12 months of follow-up.

Institution
MUSC
Recruitment Contact
Lisa Mock
843-876-2211
mockl@musc.edu



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