Phase
Condition
Sprains
Tendon Injuries
Treatment
Placebo
secukinumab
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signed informed consent must be obtained prior to participation in the study.
Males and non-pregnant, non-nursing females between 18 and 65 years of age
Rotator cuff tendinopathy (unilateral) with positive "Painful Arc Test" onexamination
Symptoms present for at least 6 weeks but not more than 6 months at Baseline
Moderate to severe rotator cuff tendinopathy demonstrated by all of the followingcriteria:
WORC score ≤ 40 at Baseline
NRS pain score ≥ 5 at Baseline and at least 3 days of the past 7 days prior toBaseline
Nocturnal pain at least 4 out of past 7 days in the week prior to Baseline
Failure to at least 8 weeks of conventional therapy prior to Baseline: inadequateresponse to NSAIDs and/or paracetamol and physiotherapy; or intolerance to NSAIDsand/or paracetamol
Exclusion
Exclusion Criteria:
Greater than 50% partial thickness tear as established by MRI or ultrasound duringassessment in Run-in phase
Patients who are expected to require glucocorticoid treatment throughout the trialduration at Baseline (e.g., systemic, intramuscular, local injections in shoulder)
Previous surgery, or plans for surgery, during the study period, in the affectedshoulder
Rheumatologic and chronic inflammatory diseases, including but not limited toinflammatory bowel disease, polymyalgia rheumatica (PMR), PsA, axSpA and rheumatoidarthritis (RA), fibromyalgia or severe pain disorder unrelated to the targetshoulder
Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodiespositive at Screening
History of adhesive capsulitis/frozen shoulder or calcification in the tendon (inaffected or contralateral shoulder) confirmed clinically or by medical imaging
Symptomatic osteoarthritis of the shoulder (glenohumeral, acromioclavicular) inaffected or contralateral shoulder confirmed by medical imaging
Patients with traumatic rupture that would be considered eligible for surgery forrepair of cuff tear.
Neurological conditions including but not limited to cervical radiculopathy, whichin the opinion of the investigator may explain the patient's symptoms
Any intra-articular/subacromial glucocorticoid treatment within 12 weeks prior toBaseline or more than 2 injections for the current tendinopathy.
Any oral, intramuscular or i.v. glucocorticoid treatment 12 weeks prior to Baselineor during the current tendinopathy, whichever takes longer
Previous platelet rich plasma (PRP) injections or fluoroquinolone/quinoloneantibiotics within 12 weeks prior to Baseline or during the current tendinopathy,whichever takes longer
Neuromuscular or primary/secondary muscular deficiency which limits the ability toperform functional measurement (e.g., shoulder strength test)
Previous hyaluronic injections within 12 weeks prior to Baseline or during thecurrent tendinopathy, whichever takes longer
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Muenchen, Bavaria 80809
GermanySite Not Available
Novartis Investigative Site
Hannover, Niedersachsen 30159
GermanySite Not Available
Novartis Investigative Site
Bad Doberan, 18209
GermanySite Not Available
Novartis Investigative Site
Berlin, 10787
GermanySite Not Available
Novartis Investigative Site
Cottbus, 03042
GermanySite Not Available
Novartis Investigative Site
Dresden, 01069
GermanySite Not Available
Novartis Investigative Site
Eichstatt, 85072
GermanySite Not Available
Novartis Investigative Site
Eichstätt, 85072
GermanySite Not Available
Novartis Investigative Site
Erlangen, 91054
GermanySite Not Available
Novartis Investigative Site
Frankfurt am Main, 60313
GermanySite Not Available
Novartis Investigative Site
Giessen, 35392
GermanySite Not Available
Novartis Investigative Site
Gladbeck, 45968
GermanySite Not Available
Novartis Investigative Site
Gommern, 39245
GermanySite Not Available
Novartis Investigative Site
Greifswald, 17475
GermanySite Not Available
Novartis Investigative Site
Halle S, 06120
GermanySite Not Available
Novartis Investigative Site
Halle Saale, 06120
GermanySite Not Available
Novartis Investigative Site
Hamburg, 22415
GermanySite Not Available
Novartis Investigative Site
Heinsberg, 52525
GermanySite Not Available
Novartis Investigative Site
Herne, 44649
GermanySite Not Available
Novartis Investigative Site
Karlsruhe, 76133
GermanySite Not Available
Novartis Investigative Site
Leipzig, 04103
GermanySite Not Available
Novartis Investigative Site
Magdeburg, 39110
GermanySite Not Available
Novartis Investigative Site
Mainz, 55131
GermanySite Not Available
Novartis Investigative Site
Oldenburg In Holstein, 23758
GermanySite Not Available
Novartis Investigative Site
Ravensburg, 88214
GermanySite Not Available
Novartis Investigative Site
Reinfeld, 23858
GermanySite Not Available
Novartis Investigative Site
Schoenebeck, 39218
GermanySite Not Available
Novartis Investigative Site
Wertheim, 97877
GermanySite Not Available
Novartis Investigative Site
Wuerzburg, 97074
GermanySite Not Available
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