Stratification of Biologic Therapies for Rheumatoid Arthritis by Pathobiology (STRAP): A randomised, open-labelled biopsy driven stratification trial in DMARD inadequate responder patients randomised to etanercept, tocilizumab or rituximab

Queen Mary University of London0 sites187 target enrollmentNovember 5, 2015

Overview

No summary available.

Registry

who.int

Start Date

November 5, 2015

End Date

January 9, 2021

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

•Current inclusion criteria as of 08/09/2017:
•1\. 2010 ACR / EULAR Rheumatoid Arthritis classification criteria for a diagnosis of RA \*
•2\. Patient with DMARD failure eligible for anti\-TNF\-a therapy as per UK NICE guidelines\*\*
•3\. Patients must have a minimum of 3 swollen joints – the joint selected for biopsy and a minimum of 2 from 28 joint count set, as assessed at biopsy visit
•4\. Selected joint for biopsy must be minimum grade 2 synovial thickening, as assessed at the biopsy visit
•5\. 18 years of age and over
•6\. Patients must be capable of giving informed consent and the consent must be obtained prior to any screening procedures
•\* The ACR/EULAR classification for a diagnosis of RA could have been at any time in the patient’s disease history; the score does not need to be 6 or more at screening.
•\*\* Current NICE guidelines available at the following link: http://www.nice.org.uk/guidance/ta375\.
•Previous inclusion criteria:

•Current exclusion criteria as of 08/09/2017:
•Patients will be excluded if they have any contraindication to Etanercept, Rituximab or Tocilizumab therapy:
•1\. Women who are pregnant or breast\-feeding
•2\. Women of child\-bearing potential or males whose partners are women of child\-bearing potential, unwilling to use an effective method of contraception(recommend double contraception) throughout the trial and beyond the end of trial treatment for the duration as defined in the relevant SmPC; 12 months for Rituximab, at least 3 weeks for Etanercept, and at least 3 months for Tocilizumab.
•3\. History of or current primary inflammatory joint disease or primary rheumatological autoimmune disease other than RA(if secondary to RA, then the patient is still eligible).
•4\. Prior exposure to Rituximab, any anti\-TNF, Tocilizumab, or any other biologic for treatment of RA
•5\. Treatment with any investigational agent \= 4 weeks prior to baseline or \< 5 half\-lives of the investigational drug (whichever is the longer)
•6\. Intra\-articular or parenteral corticosteroids \= 4 weeks prior to screening visit.
•7\. Oral prednisolone more than 10mg/d or equivalent \= 4 weeks prior to baseline synovial biopsy.
•8\. Active infection