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Regulatory Focus™ > News Articles > EMA Adopts Guideline on Clinical Trials for Rheumatoid Arthritis Treatments

EMA Adopts Guideline on Clinical Trials for Rheumatoid Arthritis Treatments

Posted 10 January 2018 | By Zachary Brennan 

EMA Adopts Guideline on Clinical Trials for Rheumatoid Arthritis Treatments

The European Medicines Agency (EMA) on Wednesday announced the adoption of a guideline, first drafted in 2011, on the clinical evaluation of medicinal products in the treatment of the autoimmune disease rheumatoid arthritis (RA).

"Currently, several biomarkers which may predict disease progression and response are under development. In the future, this may lead to a more individually targeted treatment approach," the guideline said. "Despite significant advances in the treatment of RA in the last decade, there are still a considerable number of patients who do not tolerate or who are resistant to available pharmacological treatment options. New treatment options are therefore in demand."

The guideline, which is set to take effect 1 July 2018, features sections on the criteria and standards for patient selection, possible indications or treatment goals, how to assess efficacy, the strategy and design of clinical trials, clinical safety evaluations and studies in special populations including the elderly and children.

"This document is a revision of the Points to Consider adopted in November 2003," EMA said. "Pharmacological therapy has advanced for RA in the last decade. Therapeutic strategies employing more intensive intervention in early disease, often using combinations of non-biologic and biologic DMARDs [disease-modifying anti-rheumatic drugs], have shown a faster onset of action and more profound clinical responses than traditional approaches."

EMA noted that the optimum treatment goal is remission, or at least low disease activity in patients that do not respond to earlier treatments.

In terms of what has changed since 2003, the guideline said new classification criteria for RA have been developed and validated by the American College of Rheumatology’s European League against Rheumatism that allows for earlier DMARD use.

"This has led to new endpoints reflecting treatment targets of remission or low-disease activity at earlier time points, in place of the previous primary endpoint of meeting ACR20 improvement criteria at 6 months. Furthermore, a distinction is currently made in this Guideline between trials in DMARD-naïve RA patients or in patients who have had an inadequate response (IR) to prior therapy with DMARDs. Recommendations are also introduced on how to measure the prevention of structural bone damage," the guideline adds.

Guideline on clinical investigation of medicinal products for the treatment of rheumatoid arthritis


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