DEKAVIL (F8-IL10)

PH-F8IL10-02/08

Study protocol title: A dose-finding, pharmacokinetic Phase I study of the human  monoclonal antibody-cytokine fusion protein F8IL10 (Dekavil) in combination with Methotrexate in patients with active rheumatoid arthritis.

Study purpose: To establish the maximum tolerated dose (MTD) and the recommended dose (RD) of F8IL10 when administered in combination with Methotrexate.

Number of patients: A maximum of 33 patients.

Current status: Recruiting.

Study centres:

• Azienda Ospedaliera Universitaria Senese, Policlinico Santa Maria alle Scotte, U.O.C. Reumatologia, Viale Bracci 16 – 53100 Siena, Italy.

• Fondazione IRCCS Policlinico “San Matteo”, U.O. Reumatologia, Via Le Golgi 19 - 27100 Pavia, Italy.