Drug Regulators, EMEA, Publish Concept Paper on Need to Revise Points to Consider on the Clinical Investigation of Medicinal Products Other than NSAIDs in Rheumatoid Arthritis.
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Since 2003 this guideline has presented guidance for the clinical development of slow-acting anti-rheumatic medicinal products aiming at symptom- and/or structure-modification (e.g. DMARDs, biologics) for the treatment of rheumatoid arthritis (RA). In the last years efforts have been made in that field with regard to the development of new products with an improved efficacy profile and novel insights have been gained with respect to the assessment of disease activity, joint damage and disability. Furthermore, new treatment strategies have been established which relate to early therapy, tight control and rapid switching of medication. Accordingly, new EULAR/ACR recommendations have been developed. Therefore several important additions and changes are needed to express the current state of scientific knowledge in this guideline.
The search for improved and meaningful endpoints and study designs adapted to the changed pharmacologic profile of new agents and elaborated treatment strategies has prompted several groups of scientists to develop new recommendations for conducting clinical studies in RA. A need is identified to update the regulatory guidance on the clinical development of medicinal products intended for the treatment of RA.
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