Phase
Condition
Sprains
Tendon Injuries
Treatment
Secukinumab
Placebo
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Unilateral rotator cuff tendinopathy with ≥ 6 weeks to ≤ 6 months symptom durationat baseline.
Nocturnal pain in shoulder on at least 3 out of 7 nights in the week prior tobaseline or "positive painful arc test" on examination.
Total WORC percentage score ≤ 40 at the screening and baseline visits.
Average weekly (i.e., the average of the 7 scores taken once a day) numerical ratingscale (NRS) pain score of ≥5 during the past 7 days prior to the baseline visit.
Refractory to standard of care: non-steroidal anti-inflammatory drug (NSAIDs) courseas per local standard practice (if not intolerant or contraindicated) and a courseof physiotherapy over a period of 8 weeks.
Participant agreed to remain on stable NSAID dosage regimen (if not intolerant orhaving contraindications; NSAID dose was permitted to be reduced, but not increasedabove dose established at run-in) and physiotherapy regimen from run-in period untilEnd of Study (EOS).
Presence of tendinopathy in the affected shoulder on a centrally read MRI (MagneticResonance Imaging), with the following conditions: with no tear or partial tear (maximum 50% tendon thickness; anteroposterior (AP) length maximum 10 mm)
Exclusion
Exclusion Criteria:
Rheumatological and non-rheumatological inflammatory diseases, including but notlimited to polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), axialspondyloarthritis (AS: ankylosing spondylitis, nr-axSpA: non-radiographic axialspondyloarthritis), psoriasis (PsO), and rheumatoid arthritis (RA); fibromyalgia orsevere pain disorder unrelated to the target shoulder; gout; and systemic lupuserythematosus.
Rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) antibodiespositive at screening.
Oral, intramuscular or intravenous (i.v.) corticosteroid treatment within the last 12 weeks prior to randomization, or presence of any condition that might requireintermittent corticosteroid use.
Lack of compliance with adhering to NSAID (unless intolerant or contraindicated) andphysiotherapy regimen during run-in period.
Positive painful arc test result in contralateral shoulder
Inability or unwillingness to undergo MRI of the shoulder (e.g., participants withpacemakers, or metal fragments/foreign objects in the body that were not compatiblewith performing an MRI) to fulfill eligibility criteria (unless centrally read MRIimages acquired within 3 months of baseline could be provided and the quality ofimages was deemed sufficient).
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires C1055AAF
ArgentinaSite Not Available
Novartis Investigative Site
San Miguel De Tucuman, Tucuman 4000
ArgentinaSite Not Available
Novartis Investigative Site
San Miguel Tucuman, Tucumán Province 3833578 4000
ArgentinaSite Not Available
Novartis Investigative Site
Buenos Aires, C1114AAP
ArgentinaSite Not Available
Novartis Investigative Site
Buenos Aires 3435910, C1114AAP
ArgentinaSite Not Available
Novartis Investigative Site
San Miguel de Tucumán 3836873, 4000
ArgentinaSite Not Available
Novartis Investigative Site
Tucuman, 4000
ArgentinaSite Not Available
Novartis Investigative Site
Sofia, 1632
BulgariaSite Not Available
Novartis Investigative Site
Sofia 727011, 1336
BulgariaSite Not Available
Novartis Investigative Site
Sherbrooke, Quebec J1L 0H8
CanadaSite Not Available
Novartis Investigative Site
Québec 6325494, Quebec 6115047 G1V 3M7
CanadaSite Not Available
Novartis Investigative Site
Quebec, G1V 3M7
CanadaSite Not Available
Novartis Investigative Site
Santiago, RM 7500588
ChileSite Not Available
Novartis Investigative Site
Vitacura, Santiago 7640881
ChileSite Not Available
Novartis Investigative Site
Brno, Czech Republic 66250
CzechiaSite Not Available
Novartis Investigative Site
Brno 3078610, Czech Republic 66250
CzechiaSite Not Available
Novartis Investigative Site
Praha, Czech Republic 19000
CzechiaSite Not Available
Novartis Investigative Site
Kolin, 280 02
CzechiaSite Not Available
Novartis Investigative Site
Kolín 3073371, 280 02
CzechiaSite Not Available
Novartis Investigative Site
Pardubice, 53002
CzechiaSite Not Available
Novartis Investigative Site
Vejle, 7100
DenmarkSite Not Available
Novartis Investigative Site
Orleans, Cedex 2 45067
FranceSite Not Available
Novartis Investigative Site
Limoges, Haute Vienne 87000
FranceSite Not Available
Novartis Investigative Site
Dijon, 21034
FranceSite Not Available
Novartis Investigative Site
Le Mans, 72037
FranceSite Not Available
Novartis Investigative Site
Nantes Cedex 1, 44093
FranceSite Not Available
Novartis Investigative Site
St-Priest-en-Jarez, 42270
FranceSite Not Available
Novartis Investigative Site
Kota Kinabalu, Sabah 88300
MalaysiaSite Not Available
Novartis Investigative Site
Kota Kinabalu 1733432, Sabah 1733039 88300
MalaysiaSite Not Available
Novartis Investigative Site
Kuala Lumpur, 59100
MalaysiaSite Not Available
Novartis Investigative Site
Selangor Darul Ehsan, 68100
MalaysiaSite Not Available
Novartis Investigative Site
Lisboa, 1050-034
PortugalSite Not Available
Novartis Investigative Site
Ponte de Lima, 4990 041
PortugalSite Not Available
Novartis Investigative Site
Ponte de Lima 2736041, 4990-041
PortugalSite Not Available
Novartis Investigative Site
Bratislava, SK-82606
SlovakiaSite Not Available
Novartis Investigative Site
Dolny Kubin, 026 01
SlovakiaSite Not Available
Novartis Investigative Site
Piestany, 92101
SlovakiaSite Not Available
Novartis Investigative Site
Bursa, Gorukle 16059
TurkeySite Not Available
Novartis Investigative Site
Istanbul, TUR 34098
TurkeySite Not Available
Novartis Investigative Site
Ankara, 06230
TurkeySite Not Available
Novartis Investigative Site
Izmir, 35040
TurkeySite Not Available
Novartis Investigative Site
London, SW17 0QT
United KingdomSite Not Available
Arizona Research .
Phoenix, Arizona 85053
United StatesSite Not Available
Elite Clinical Studies .
Phoenix, Arizona 85018
United StatesSite Not Available
Novartis Investigative Site
Phoenix, Arizona 85018
United StatesActive - Recruiting
Fiel Family Sports Medicine
Tempe, Arizona 85283
United StatesSite Not Available
Novartis Investigative Site
Tempe, Arizona 85283
United StatesActive - Recruiting
Novartis Investigative Site
Tucson, Arizona 85712
United StatesActive - Recruiting
Tucson Orthopedic Institute PC
Tucson, Arizona 85712
United StatesSite Not Available
Novartis Investigative Site
El Cajon, California 92020
United StatesActive - Recruiting
TriWest Reserach Associates .
El Cajon, California 92020
United StatesSite Not Available
Novartis Investigative Site
La Mesa, California 91942
United StatesSite Not Available
Purushotham Akther and Roshan Kotha MD Inc
La Mesa, California 91942
United StatesSite Not Available
Millennium Clinical Trials
Simi Valley, California 93065
United StatesSite Not Available
Millennium Clinical Trials
Thousand Oaks, California 91360
United StatesSite Not Available
Novartis Investigative Site
Thousand Oaks, California 91360
United StatesActive - Recruiting
Millennium Clinical Trials
Westlake Village, California 91361
United StatesSite Not Available
Millennium Clinical Trials
Westlake Village 5408395, California 5332921 91361
United StatesSite Not Available
CoastalOrthoandSportsMedofSWFlorida .
Bradenton, Florida 34209
United StatesSite Not Available
Novartis Investigative Site
Bradenton, Florida 34209
United StatesActive - Recruiting
Novartis Investigative Site
Doral, Florida 33166
United StatesActive - Recruiting
Universal Axon Clinical Research
Doral, Florida 33166
United StatesSite Not Available
Healthy Life Research
Miami, Florida 33184
United StatesSite Not Available
Healthy Life Research .
Miami, Florida 33184
United StatesSite Not Available
Novartis Investigative Site
Miami, Florida 33184
United StatesActive - Recruiting
IRIS Research and Development
Plantation, Florida 33324
United StatesSite Not Available
Integral Rheumatology and Immunology Specialists IRIS
Plantation, Florida 33324
United StatesSite Not Available
Novartis Investigative Site
Plantation, Florida 33324
United StatesActive - Recruiting
Novartis Investigative Site
Sunrise, Florida 33351
United StatesActive - Recruiting
Precision Clinical Research LLC
Sunrise, Florida 33351
United StatesSite Not Available
Healthy Life Research
Miami 4164138, Florida 4155751 33184
United StatesSite Not Available
IRIS Research and Development
Plantation 4168782, Florida 4155751 33324
United StatesSite Not Available
Precision Clinical Research LLC
Sunrise 4174402, Florida 4155751 33351
United StatesSite Not Available
Chicago Clinical Research Inc
Chicago, Illinois 60607
United StatesActive - Recruiting
Chicago Clinical Research Inst
Chicago, Illinois 60607
United StatesSite Not Available
Novartis Investigative Site
Chicago, Illinois 60607
United StatesActive - Recruiting
Affinity Health Corp
Oak Brook, Illinois 60523
United StatesSite Not Available
Novartis Investigative Site
Oak Brook, Illinois 60523
United StatesActive - Recruiting
Novartis Investigative Site
Saint Louis, Missouri 63141
United StatesActive - Recruiting
Sundance Clinical Research LLC
Saint Louis, Missouri 63141
United StatesSite Not Available
Inspire Santa Fe Medical Group Rheumatology
Santa Fe, New Mexico 87505
United StatesSite Not Available
Novartis Investigative Site
Santa Fe, New Mexico 87505
United StatesActive - Recruiting
Novartis Investigative Site
Morehead City, North Carolina 28557
United StatesActive - Recruiting
West Clinical Research
Morehead City, North Carolina 28557
United StatesSite Not Available
West Clinical Research
Morehead City 4480153, North Carolina 4482348 28557
United StatesSite Not Available
Altoona Center for Clin Res .
Duncansville, Pennsylvania 16635
United StatesSite Not Available
Novartis Investigative Site
Duncansville, Pennsylvania 16635
United StatesActive - Recruiting
Antria Inc .
Indiana, Pennsylvania 15701
United StatesSite Not Available
Novartis Investigative Site
Indiana, Pennsylvania 15701
United StatesActive - Recruiting
Medical Univ of South Carolina .
Charleston, South Carolina 29425
United StatesSite Not Available
Novartis Investigative Site
Charleston, South Carolina 29425
United StatesActive - Recruiting
Coastal Carolina Research Center .
Mount Pleasant, South Carolina 29464
United StatesSite Not Available
Novartis Investigative Site
Mount Pleasant, South Carolina 29464
United StatesActive - Recruiting
Novartis Investigative Site
Jackson, Tennessee 38305
United StatesActive - Recruiting
West Tennessee Research Institute
Jackson, Tennessee 38305
United StatesSite Not Available
West Tennessee Research Institute
Jackson 4632595, Tennessee 4662168 38305
United StatesSite Not Available
Virginia Ispine Physicians PC
Richmond, Virginia 23238
United StatesSite Not Available

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