Clinical Trials in Rheumatoid Arthritis and Osteoarthritis

Description

Designed to be a practical handbook on clinical trial management in these key therapeutic areas, 'Clinical Trials in Rheumatoid Arthritis and Osteoarthritis' is aimed at principal investigators pharmaceutical physicians and other pharmaceutical staff involved in the design, conduct and monitoring of these increasingly complex diseases. In the last several years a new classes of biologic agents have emerged and changed the treatment paradigm for patients, not only with classically defined rheumatoid arthritis, but also with other related diseases such as ankylosing spondylitis and psoriatic arthritis. Furthermore, osteoarthritis is a major disease state that is often treated by the rheumatologist, but is one where patient management programs are currently limited with a need for new therapeutic approaches. In both inflammatory and non-inflammatory arthritic conditions, clinical trials have become both large and complex due to the nature of the diseases, with ever-challenging new surrogate end-points being employed. Topics covered in this title will therefore include study design, clinical endpoints, technical issues, data collection, use of centralized medical image reading facilities and biochemical marker laboratories, as well as data analysis and future therapies. This book takes the user through the process step-by-step from start to finish, also providing a background on the regulatory guidelines, ethical implications, endpoints, and current therapies. Front Matter....Pages I-VIII Introduction....Pages 1-3 Historical and Current Perspectives on Management of Osteoarthritis and Rheumatoid Arthritis....Pages 5-36 Development of Biological Therapies for Inflammatory Arthritis....Pages 37-49 Study Design and End Points for Rheumatoid Arthritis Trials....Pages 51-67 Study Design and End Points in Ankylosing Spondylitis Clinical Trials....Pages 69-79 Trial Design and Outcomes in Osteoarthritis....Pages 81-90 Ethical Considerations....Pages 91-111 Organization of the Clinical Trial by the Sponsor....Pages 113-122 Organization of the Trial attheInvestigator Site....Pages 123-134 Role of the Imaging Core Laboratory in Rheumatoid Arthritis and Osteoarthritis Clinical Trials....Pages 135-150 Biochemical Markers of Rheumatoid Arthritis and Osteoarthritis: Clinical Utility and Practical Considerations....Pages 151-169 Data Analysis and Presentation: Writing a Paper for Publication....Pages 171-199 Radiographic Imaging End Points in Rheumatoid Arthritis Trials....Pages 201-221 Radiography in Clinical Trials Investigating Osteoarthritis....Pages 223-234 Use of Quantitative Magnetic Resonance Imaging in the Cross-Sectional and Longitudinal Evaluation of Structural Changes in Knee Osteoarthritis Patients....Pages 235-248 Biochemical Markers as Surrogate End Points of Joint Disease....Pages 249-274 Role of Genetics and Genomics in Clinical Trials in Osteoarthritis and Rheumatoid Arthritis....Pages 275-287 Cost-Effectiveness of New Biologics for Rheumatoid Arthritis and Osteoarthritis....Pages 289-307 Back Matter....Pages 309-325