Protocol Title : A Randomised, open labelled study in anti ... - EME

Protocol Version 3 14/01/2013
STUDY SUMMARY/SYNOPSIS
TITLE Developing a novel, biopsy-based diagnostic for patient
stratification: “A Randomised, open labelled studyin anti-
TNFa inadequate responders to investigate the
mechanisms for Response - Resistance to Rituximab
versus Tocilizumab in RA (R4-RA)”.
SHORT TITLE R4-RA
Protocol Version
Number and Date
Methodology
Study Duration
Study Centre
Objectives
Phase of the Trial
Number of
Subjects/Patients
Main Inclusion Criteria
Protocol 3, 14/01/2012
Type of study: single-blind, randomised controlled clinical
trial
4 years
Barts and The Royal London NHS Trust
This study will aim to develop a diagnostic tool
(immunohistochemical analysis of synovial tissue) for
patient stratification into responsive/non-responsive
categories with respect to Rituximab therapy in patients
who have had an inadequate response to anti-TNF
therapy. Specifically, can a diagnostic synovial biopsy
showing a B-cell “rich/poor pathotype” define specific
disease responsive/resistant subsets for patient
stratification and help rationalize biologic drug choice?
Phase IV study
180
Patients will be recruited with active RA:
1. Patients who have failed anti-TNF therapy
(inadequate responders – ir).
2. Patients who are seropositive for Rheumatoid
Factor and/ or Anti-CCP antibodies.
3. Who are eligible for Rituximab therapy according
NICE guidlines
4. Patients should be receiving a stable dose
Methotrexate for at least 4 weeks prior to
screening.
5. 2010 ACR / EULAR Rheumatoid Arthritis
classification criteria for a diagnosis of
Rheumatoid Arthritis.
6. Over 18 years of age
7. Patient must be capable of giving informed
consent
8. Willingness and ability to comply with scheduled
visits, treatment plans and laboratory tests and
other study procedures
Study: R4RA EudraCT: 2012-002535-28 6 / 34