NCT02076659

Combination Therapy of F8IL10 and Methotrexate in Rheumatoid Arthritis Patients

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Philogen S.p.A. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Phase I, multicenter, open-label, dose escalation study to test the efficacy and safety of F8IL10 and methotrexate when given as a combination in rheumatoid arthritis patients.

Detailed description

The study is designed to explore whether F8IL10 can be safely administered in combination with standard-dose of MTX in patients with active rheumatoid arthritis and to determine the recommended dose of F8IL10 when combined with MTX. As soon as the MTD/RD is determined, an additional 12 patients will be randomized (6+6) between F8IL10 (RD) and placebo to further investigate the safety and pharmacacodynamics profile of the study treatment. Methotrexate (MTX) will be administered as concomitant medication in the dose escalation as well as in the randomized part of the study.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	F8IL10	Weekly administration of F8IL10 (from 6 to 600 μg/kg), starting from 6 μg/kg cohort 1. The cohort 10 represents the last dose-level of the study. F8IL10 will be administered as subcutaneous (s.c.) injections. Patients will receive 4 cycles of treatment unless there is unacceptable toxicity or withdrawal of consent.
DRUG	Methotrexate	Methotrexate will be administered at a fixed dose of 10-15 mg on Day 1, orally (p.o.), subcutaneously (s.c.) or intramuscularly (i.m.). Patients will receive 4 cycles of treatment unless there is unacceptable toxicity or withdrawal of consent.

Timeline

• Start date: 2011-09-01
• Primary completion: 2017-04-01
• Completion: 2017-04-13
• First posted: 2014-03-03
• Last updated: 2018-05-18

Locations

5 sites across 1 country: Italy