A Multicenter Study of rhFGF 18 in Patients With Knee Osteoarthritis Not Requiring Surgery

Exclusion Criteria

• •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
• •clinically significant abnormal hematology (hemoglobin, leucocytes, and platelets), or blood chemistry values (aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), bilirubin, and creatinine
• •receipt of any investigational product or any experimental therapeutic procedure within the last 12 weeks preceding screening
• •participation in FIH study 27575 or in a different cohort of this study
• •i.a. treatment of the target knee with steroids or hyaluronic acid derivatives within the 3 months before baseline
• •for MAD cohorts, any contra-indications to MRI according to MRI guidelines
• •any condition that would interfere with efficacy or safety assessments in the target knee
• •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
• •use of electrotherapy or acupuncture for OA, unless there is a stable regimen for at least 4 weeks before baseline
• •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
• •history of sarcoma and/or of other active malignancy within five years, except adequately treated basal cell or squamous cell carcinoma of the skin
• •signs and symptoms suggestive of transmissible spongiform encephalopathy
• •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