Phase
Condition
Knee Injuries
Osteoarthritis
Treatment
Placebo to canakinumab
LNA043
canakinumab
Clinical Study ID
Ages 40-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Moderate to severe OA pain (corresponding to NRS Pain ≥5 to ≤9) in the target kneefor the majority of days in the last 3 months prior to Screening
KOOS pain subscale <60 for the target knee during Screening
High sensitivity C-reactive Protein (hsCRP) ≥1.8 mg/L
Radiographic KL grade 2 to 4 knee OA and joint space width (JSW) 2.0-4.0 mm (men) or 1.5-3.5 mm (women) in the medial tibiofemoral compartment (TFC) in the target knee
Contrast-enhanced MRI (CE-MRI) diagnosed moderate or severe knee synovitis based onan established synovititis scoring system (moderate score 9-12 or severe score ≥13)
Exclusion
Exclusion Criteria:
History of, or planned; knee replacement (partial or total) in either knee;arthroscopy or lavage in either knee within 6 months prior to screening; any otherprevious surgical intervention in the target knee, or for the contralateral kneewithin 12 months prior to Screening, including mosaicplasty, microfracture,meniscectomy >50% or osteotomy
Moderate to severe pain in the contralateral knee for the majority of days in thelast 3 months prior to screening
Malalignment >7.5° in the target knee (either varus or valgus)
Any diagnosis of systemic inflammatory arthritis or connective tissue disease,including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosingspondylitis, gout, Paget's disease, systemic lupus erythematosus) or other systemiccondition that might confound assessment of OA (e.g. fibromyalgia)
Ipsilateral hip OA or hip prosthesis recently implanted (within 1 year prior toscreening) or hip replacement on either side planned within the study period
Study Design
Connect with a study center
Novartis Investigative Site
Guangzhou, Guangdong 510515
ChinaSite Not Available
Novartis Investigative Site
Wuhan, Hubei 430022
ChinaSite Not Available
Novartis Investigative Site
Zhuzhou, Hunan 412000
ChinaSite Not Available
Novartis Investigative Site
Hohhot, Inner Mongolia 010017
ChinaSite Not Available
Novartis Investigative Site
Beijing, 100044
ChinaSite Not Available
Novartis Investigative Site
Brno, Czech Republic 66250
CzechiaSite Not Available
Novartis Investigative Site
Pardubice, Czech Republic 530 02
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
Uherske Hradiste, 686 01
CzechiaSite Not Available
Novartis Investigative Site
Tallinn, 10128
EstoniaSite Not Available
Novartis Investigative Site
Tartu, 50406
EstoniaSite Not Available
Novartis Investigative Site
Bad Doberan, 18209
GermanySite Not Available
Novartis Investigative Site
Berlin, 10117
GermanySite Not Available
Novartis Investigative Site
Giessen, 35392
GermanySite Not Available
Novartis Investigative Site
Herne, 44649
GermanySite Not Available
Novartis Investigative Site
Muenster, 48149
GermanySite Not Available
Novartis Investigative Site
Kecskemet, Bacs Kiskun 6044
HungarySite Not Available
Novartis Investigative Site
Szekesfehervar, Fejer 8000
HungarySite Not Available
Novartis Investigative Site
Budapest, 1036
HungarySite Not Available
Novartis Investigative Site
Gyor, 9024
HungarySite Not Available
Novartis Investigative Site
Zalaegerszeg, 8900
HungarySite Not Available
Novartis Investigative Site
Riga, 1005
LatviaSite Not Available
Novartis Investigative Site
Vilnius, LTU LT-08406
LithuaniaSite Not Available
Novartis Investigative Site
Kaunas, 44320
LithuaniaSite Not Available
Novartis Investigative Site
Gliwice, 44100
PolandSite Not Available
Novartis Investigative Site
Krakow, 31-501
PolandSite Not Available
Novartis Investigative Site
Warszawa, 02-677
PolandSite Not Available
Novartis Investigative Site
St Petersburg, 190068
Russian FederationSite Not Available
Novartis Investigative Site
Lausanne, 1011
SwitzerlandSite Not Available
Novartis Investigative Site
St Gallen, CH 9007
SwitzerlandSite Not Available
Horizon Clinical Research
La Mesa, California 91942
United StatesSite Not Available
Novartis Investigative Site
La Mesa, California 91942
United StatesSite Not Available
Clinical Res Of W Florida
Clearwater, Florida 33765
United StatesSite Not Available
Clinical Res. of W Florida
Clearwater, Florida 33765
United StatesSite Not Available
Clinical Research of West Florida
Clearwater, Florida 33765
United StatesSite Not Available
Novartis Investigative Site
Clearwater, Florida 33765
United StatesActive - Recruiting
Novartis Investigative Site
Sunrise, Florida 33351
United StatesActive - Recruiting
Precision Clinical Research LLC
Sunrise, Florida 33351
United StatesSite Not Available
Novartis Investigative Site
Kansas City, Kansas 66160-7330
United StatesSite Not Available
LV Research
Las Vegas, Nevada 89119
United StatesSite Not Available
Novartis Investigative Site
Las Vegas, Nevada 89119
United StatesActive - Recruiting
Lucas Research .
Morehead City, North Carolina 28557
United StatesSite Not Available
Novartis Investigative Site
Morehead City, North Carolina 28557
United StatesActive - Recruiting
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