Date: 2011-04-04
Type of information:
phase: 1-2
Announcement: authorization delivered by Afssaps (French drug agency)
Company: TxCell (France)
Product: TX-RAD (type 1 regulatory T cell based immunotherapy)
Action mechanism: immunotherapy
Disease: rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country: France
Trial
details: The study RATS1 (Rheumatoid arthritis And Tr1 Study) will evaluate the safety and efficacy of the administration of TX-RAD, a type 1 regulatory T cell based immunotherapy, in patients with moderate to severe rheumatoid arthritis, who failed current treatments.
The planned study is an open label, 12 weeks multicenter phase I/II clinical trial. It will assess the tolerability and explore the efficacy of three consecutive injections of TX-RAD at escalating doses in patients with rheumatoid arthritis refractory to standard treatments including biologics. The trial will be conducted in several clinical sites in France. The study will include clinical, quality of life and joint imaging assessments.
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