Rheumatology, Osteoarthritis, Rheumatoid Arthritis
14. Jan 2019
Potential diagnostic value of a type X collagen neo-epitope biomarker for knee osteoarthritis.
OBJECTIVE:
Phenotypic changes of chondrocytes toward hypertrophy might be fundamental in the pathogenesis of OA, of which type X collagen (Col10) is a well-known marker. The purpose was to develop a specific immunoassay for blood quantification of a newly identified neo-epitope of type X collagen t…
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Journal:
Authors:
- He Y,
- Manon-Jensen T,
- Arendt-Nielsen L,
- Petersen KK,
- Christiansen T,
- Samuels J,
- Abramson S,
- Karsdal MA,
- Attur M,
- Bay-Jensen AC,
Rheumatology, Osteoarthritis
19. Nov 2018
Proposed study designs for approval based on a surrogate endpoint and a post-marketing study under FDA's accelerated approval regulations for disease modifying osteoarthritis drugs
In 1992, the Food and Drug Administration (FDA) instituted the accelerated approval regulations that allow drugs or biologics for serious conditions that fill an unmet medical need to be approved on the basis of a surrogate endpoint or an intermediate clinical endpoint. The current definition of a s…
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Journal:
Authors:
- Kraus VB,
- Simon LS,
- Katz JN,
- Neogi T,
- Hunter D,
- Guermazi A,
- Karsdal MA,