Age | Postmenopausal state | Female Sterilization
Item
1. male or female >= 40 years of age; females must be postmenopausal or surgically sterile
boolean
C0001779 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
Osteoarthritis femorotibial Target Knee | Disease length
Item
2. established diagnosis of primary femoro-tibial oa of the target knee by standard american college of rheumatology criteria for at least six months (clinical and radiological criteria)
boolean
C0029408 (UMLS CUI [1,1])
C1269072 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C0022742 (UMLS CUI [1,4])
C0872146 (UMLS CUI [2])
Disease Radiologic | Osteoarthritis Target Knee Kellgren-Lawrence score
Item
3. radiological disease stage 2 or 3 (i.e., clear evidence of oa, but not most advanced disease) in the target knee according to the kellgren-lawrence grading of knee oa
boolean
C0012634 (UMLS CUI [1,1])
C0205483 (UMLS CUI [1,2])
C0029408 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0022742 (UMLS CUI [2,3])
C3177117 (UMLS CUI [2,4])
Absence Major surgery Target Knee | Absence Partial Knee Replacement | Absence Total Knee Replacement | Absence Arthroscopy Interventional
Item
4. no major knee surgery (e.g., partial or total knee replacement, interventional arthroscopy) in the target knee planned for at least 12 months after first injection of the study drug
boolean
C0332197 (UMLS CUI [1,1])
C0679637 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C0022742 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C0864243 (UMLS CUI [2,2])
C0332197 (UMLS CUI [3,1])
C0086511 (UMLS CUI [3,2])
C0332197 (UMLS CUI [4,1])
C0003904 (UMLS CUI [4,2])
C0184661 (UMLS CUI [4,3])
Therapeutic procedure PRN Symptomatic | Osteoarthritis Target Knee | NSAIDs Systemic | Analgesics Systemic
Item
5. documented need for symptomatic prn (as needed)-treatment for oa in the target knee with systemic non-steroidal anti-inflammatory drugs (nsaids) and/or other analgesics.
boolean
C0087111 (UMLS CUI [1,1])
C0558288 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
C0029408 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0022742 (UMLS CUI [2,3])
C0003211 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0002771 (UMLS CUI [4,1])
C0205373 (UMLS CUI [4,2])
Target Knee WOMAC scale | Therapeutic procedure Symptomatic Oral
Item
6. total womac score between 24 and 72 (out of 96, corresponding to mild, moderate, or severe, but not extreme oa symptoms) for the target knee while on oral symptomatic treatment at baseline
boolean
C1521840 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C3472647 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C1527415 (UMLS CUI [2,3])
Protocol Compliance
Item
7. full understanding of the requirements of the study and willingness to comply with all study visits and assessments
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
8. patients must have read and understood the informed consent form, and must have signed it prior to any study-related procedure
boolean
C0021430 (UMLS CUI [1])
Condition At risk Study Subject Participation Status | Laboratory finding At risk Study Subject Participation Status | Medical History At risk Study Subject Participation Status | Assessment Pre-study At risk Study Subject Participation Status | Medical contraindication Study Subject Participation Status | Condition Interferes with Study Protocol | Condition Interferes with Completion of clinical trial | Condition Interferes with Evaluation
Item
any condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that in the opinion of the investigator constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation
boolean
C0348080 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0587081 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0262926 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C1516048 (UMLS CUI [4,1])
C1527048 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C2348568 (UMLS CUI [4,4])
C1301624 (UMLS CUI [5,1])
C2348568 (UMLS CUI [5,2])
C0348080 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C2348563 (UMLS CUI [6,3])
C0348080 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C2732579 (UMLS CUI [7,3])
C0348080 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C1261322 (UMLS CUI [8,3])
Hematology abnormal | Hemoglobin measurement | White Blood Cell Count procedure | Platelet Count measurement | Blood chemistry abnormal | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Serum total bilirubin measurement | Creatinine measurement, serum
Item
clinically significant abnormal hematology (hemoglobin, leucocytes, and platelets), or blood chemistry values (aspartate aminotransferase (ast), alanine aminotransferase (alt), alkaline phosphatase (alp), bilirubin, and creatinine
boolean
C0475182 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0438258 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
C0201850 (UMLS CUI [8])
C1278039 (UMLS CUI [9])
C0201976 (UMLS CUI [10])
Investigational New Drugs | Therapies, Investigational
Item
receipt of any investigational product or any experimental therapeutic procedure within the last 12 weeks preceding screening
boolean
C0013230 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Study Subject Participation Status | First in Human Clinical Trial
Item
participation in fih study 27575 or in a different cohort of this study
boolean
C2348568 (UMLS CUI [1])
C3641799 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
Therapeutic procedure Target Knee | Steroids | Hyaluronic Acid Derivative
Item
i.a. treatment of the target knee with steroids or hyaluronic acid derivatives within the 3 months before baseline
boolean
C0087111 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0022742 (UMLS CUI [1,3])
C0038317 (UMLS CUI [2])
C0020196 (UMLS CUI [3,1])
C1527240 (UMLS CUI [3,2])
Medical contraindication MRI
Item
for mad cohorts, any contra-indications to mri according to mri guidelines
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Condition Interferes with Evaluation | Condition Interferes with Safety Assessment | Relationship Target Knee
Item
any condition that would interfere with efficacy or safety assessments in the target knee
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0549076 (UMLS CUI [2,3])
C0439849 (UMLS CUI [3,1])
C1521840 (UMLS CUI [3,2])
C0022742 (UMLS CUI [3,3])
Pharmaceutical Preparations Changing Disease | Dietary Supplements Changing Disease | Glucosamine | diacetylrhein | Chondroitin Sulfates
Item
any drug or food supplement with potential disease-modifying effect (glucosamine, diacerin, chondroitin sulfate) unless given at a stable dose over at least 4 weeks prior to first injection
boolean
C0013227 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0242295 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0012634 (UMLS CUI [2,3])
C0017718 (UMLS CUI [3])
C0057678 (UMLS CUI [4])
C0008466 (UMLS CUI [5])
Electric Stimulation Therapy Degenerative polyarthritis | Acupuncture Degenerative polyarthritis
Item
use of electrotherapy or acupuncture for oa, unless there is a stable regimen for at least 4 weeks before baseline
boolean
C0013787 (UMLS CUI [1,1])
C0029408 (UMLS CUI [1,2])
C0394664 (UMLS CUI [2,1])
C0029408 (UMLS CUI [2,2])
Communicable Diseases | Suspicion Communicable Disease Intra-articular | Communicable Diseases Impairing Immune system | HIV Infection | Hepatitis B | Hepatitis C
Item
any known active infections, including suspicion of intra-articular infection and/or infections that may compromise the immune system such as hiv, hepatitis b or hepatitis c infection
boolean
C0009450 (UMLS CUI [1])
C0242114 (UMLS CUI [2,1])
C0009450 (UMLS CUI [2,2])
C0442108 (UMLS CUI [2,3])
C0009450 (UMLS CUI [3,1])
C0221099 (UMLS CUI [3,2])
C0020962 (UMLS CUI [3,3])
C0019693 (UMLS CUI [4])
C0019163 (UMLS CUI [5])
C0019196 (UMLS CUI [6])
Sarcoma | Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
history of sarcoma and/or of other active malignancy within five years, except adequately treated basal cell or squamous cell carcinoma of the skin
boolean
C1261473 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Signs and Symptoms Suggestive of Prion Disease
Item
signs and symptoms suggestive of transmissible spongiform encephalopathy
boolean
C0037088 (UMLS CUI [1,1])
C0332299 (UMLS CUI [1,2])
C0162534 (UMLS CUI [1,3])
Secondary osteoarthritis | Joint dysplasia | Osteonecrosis aseptic | Acromegaly | Paget's Disease | Ehlers-Danlos Syndrome | Gaucher Disease | Stickler syndrome | Arthropathy associated with infection | Hemophilia | Hemochromatosis | Calcium pyrophosphate deposition disease | Neurogenic arthropathy
Item
secondary osteoarthritis: e.g., joint dysplasias, aseptic osteonecrosis, acromegaly, paget's disease, ehlers-danlos syndrome, gaucher's disease, stickler's syndrome, joint infection, hemophilia, hemochromatosis, calcium pyrophosphate deposition disease, or neuropathic arthropathy whatever the cause
boolean
C2732281 (UMLS CUI [1])
C1395954 (UMLS CUI [2])
C0391980 (UMLS CUI [3])
C0001206 (UMLS CUI [4])
C1368019 (UMLS CUI [5])
C0013720 (UMLS CUI [6])
C0017205 (UMLS CUI [7])
C0265253 (UMLS CUI [8])
C0157749 (UMLS CUI [9])
C0684275 (UMLS CUI [10])
C0018995 (UMLS CUI [11])
C0553730 (UMLS CUI [12])
C0003892 (UMLS CUI [13])