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Clinical Trial Summary

This is a Phase 2, PoC, randomized, placebo-controlled, double blind, international multicentre study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis


Clinical Trial Description

The study foresees the randomization of at least 81 moderate to severe, ACPA positive, RA patients who are inadequate responders to MTX, in two double blind arms (NI-0101:placebo, with a ratio of 2:1). Patients will receive NI-0101 or placebo infusions up to a maximum of 6 administrations (every two weeks for 12 weeks). All patients will continue receiving a stable dose of MTX. After 12 weeks, patients will enter the follow up period with monthly visits for a minimum of 12 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03241108
Study type Interventional
Source NovImmune SA
Contact
Status Completed
Phase Phase 2
Start date May 10, 2017
Completion date June 20, 2018

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