A Multicenter Study of rhFGF 18 in Patients With Knee Osteoarthritis Not Requiring Surgery
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ClinicalTrials.gov Identifier: NCT01033994 |
Recruitment Status :
Completed
First Posted : December 17, 2009
Last Update Posted : June 25, 2014
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Tracking Information | ||||
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First Submitted Date ICMJE | December 16, 2009 | |||
First Posted Date ICMJE | December 17, 2009 | |||
Last Update Posted Date | June 25, 2014 | |||
Study Start Date ICMJE | October 2008 | |||
Actual Primary Completion Date | October 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Multicenter Study of rhFGF 18 in Patients With Knee Osteoarthritis Not Requiring Surgery | |||
Official Title ICMJE | A Randomized, Double Blind, Placebo-controlled, Multicenter, Single and Multiple Ascending Dose Study of AS902330 (rhFGF-18) Administered Intra-articularly in Patients With Primary Osteoarthritis of the Knee Who Are Not Expected to Require Knee Surgery Within One Year | |||
Brief Summary | Osteoarthritis (OA) is one of the most common diseases affecting the joints, usually those that are weight bearing such as the knees. OA is considered to be a disease of the cartilage in the joints even though it involves the whole joint, including the bone and synovium (thin lining of the joints which produces synovial fluid). With time, more and more of the cartilage is destroyed by the disease with inflammation commonly occurring. AS902330 is expected to increase the production and development of specific bone cells: chondrocytes and osteoblasts (cells that produce and maintain bone and cartilage). This is expected to lead to repair and generation of the cartilage, and a narrowing of the space width between the knee joints in a selected region of the knee cartilage. The purpose of this study is to see how safe treatment with AS902330 is, and to evaluate its effect on the knee cartilage. In addition, the study will also measure the effects of AS902330 in the blood, which reflect disease activity. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Knee Osteoarthritis | |||
Intervention ICMJE | Biological: AS902330
10, 30 or 100 µg intra-articular injection per subject in the Single Ascending Dose (SAD) cohorts and 10, 30 or 100 µg intra-articular injection per week for three weeks per subject in the Multiple Ascending Dose (MAD) cohorts.
Other Names:
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
192 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | December 2010 | |||
Actual Primary Completion Date | October 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Bulgaria, Canada, Croatia, Finland, Germany, Poland, Serbia, South Africa, Sweden | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01033994 | |||
Other Study ID Numbers ICMJE | 28980 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Merck KGaA, Darmstadt, Germany | |||
Original Responsible Party | Clinical Trial Leader, Merck Serono S.A. - Geneva, an Affiliate of Merck KGaA, Darmstadt, Germany | |||
Current Study Sponsor ICMJE | Merck KGaA, Darmstadt, Germany | |||
Original Study Sponsor ICMJE | EMD Serono | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Merck KGaA, Darmstadt, Germany | |||
Verification Date | June 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |