Efficacy And Safety Study Of Tanezumab Subcutaneous Administration In Osteoarthritis - A Subcutaneous/Intravenous Bridging Study
Status and phase
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Study type
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Identifiers
Details and patient eligibility
About
This is an efficacy and safety study of 3 doses (2.5 mg, 5 mg and 10mg) of tanezumab administered subcutaneously versus placebo. This study will also compare a subcutaneous (SC) administration of 10 mg of tanezumab) with an intravenous (IV) administration of 10 mg of tanezumab. Each person will receive an IV infusion and a SC infusion. The study will last 16 weeks for those who wish to enter a 64-week extension study or 24 weeks for those who do not.
Full description
This study was terminated on 08 Nov 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Diagnosis of osteoarthritis (OA) of the knee according to American College of Rheumatology (ACR) criteria with a Kellgren- Lawrence score of greater than or equal to 2
- 18 years of age or greater
- Two methods of birth control one of which must be barrier if of childbearing potential
- Willing to discontinue pain medication except as permitted per protocol
Exclusion criteria
- Pregnancy or wishing to be pregnant during the course of the study, lactating women
- Body Mass Index (BMI) greater than 39
- Clinically significant cardiac, neurological, psychiatric conditions and other conditions that are excluded by the protocol.
- Previous exposure to a Nerve Growth Factor (NGF) antibody
Trial design
Primary purpose
Allocation
Interventional model
Masking
385 participants in 5 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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