Planning of a Clinical Data Registry for Basic Anti-Inflammatory Drugs for the Treatment of Rheumatoid Arthritis
Rheumatoid arthritis (RA) is an autoimmune rheumatic disease of unknown etiology which manifests itself in chronic erosive arthritis (synovitis) and systemic lesions affecting internal organs. The main emphasis in the RA treatment is placed on the pharmacological therapy: non-steroidal anti-inflamma...
| Main Authors: | , |
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| Format: | Article |
| Language: | Russian |
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NEICON ISP LLC
2018-12-01
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| Series: | Ведомости Научного центра экспертизы средств медицинского применения |
| Subjects: | |
| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/196 |
| Summary: | Rheumatoid arthritis (RA) is an autoimmune rheumatic disease of unknown etiology which manifests itself in chronic erosive arthritis (synovitis) and systemic lesions affecting internal organs. The main emphasis in the RA treatment is placed on the pharmacological therapy: non-steroidal anti-inflammatory drugs, ordinary analgesics, glucocorticoids, basic synthetic anti-inflammatory drugs, and targeted therapy drugs which are now represented by genetically engineered biologicals. The choice of rational treatment options for this severe disease is an important challenge facing modern medicine. The study reported in this paper analysed the clinical data registry for basic anti-inflammatory drugs for RA treatment, which was elaborated based on RA classification and diagnostic criteria. It was revealed that a product’s indications for use are formulated in the clinical data registry based on the product’s pharmacological properties and are accompanied with the description of the target population. It is necessary to provide a list of clinical parameters that will be monitored in the study to demonstrate the efficacy of treatment. The main efficacy endpoint may be chosen based on the product’s pharmacological properties. The efficacy is assessed using integrated indicators. Expected endpoints should be in line with the declared indication for use. Trials that confirm efficacy of a product should assess its therapeutic potential to the fullest extent possible. Before a medicinal product is authorised, it is necessary to obtain sufficient data on its safety, taking into account potential risks of long-term use. |
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| ISSN: | 1991-2919 2619-1172 |