A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT

Hexal AG (a Sandoz company)0 sites100 target enrollmentNovember 16, 2015

Overview

No summary available.

Registry

who.int

Start Date

November 16, 2015

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Hexal AG (a Sandoz company)

•1\. Male or non\-pregnant, non\-lactating female patients at least 18 years of age at screening, who give written informed consent before any assessment is performed.
•2\. Patients must have the diagnosis of RA (according to American College of Rheumatology 2010 criteria).
•3\. Patients must have received at least one full treatment course of rituximab for the therapy of RA (i.e. 2 complete i. v. infusions of 1000 mg of Rituxan® in the USA or MabThera® in the EU) six to eighteen months prior to randomization.
•4\. Patients must be eligible for the subsequent treatment course with Rituxan® or MabThera® according to the clinical judgment of the Investigator.
•5\. Patients must be on a stable dose of methotrexate (MTX) (7\.5 to 25 mg per week) for at least 4 weeks prior to randomization. If patients receive a combination of DMARDs (MTX \+ hydroxychloroquine or MTX\+ chloroquine or MTX\+ sulfasalazine) these DMARDs must be also on a stable dose for at least 4 weeks prior to randomization.
•6\. Patients must be on a stable dose of folic acid or folinic acid (\= 5 mg per week) for at least 4 weeks prior to randomization.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 80

•1\. RA of functional status class IV classified according to the ACR 1991 revised criteria.
•2\. Systemic manifestation of RA, with the exception of Sjögren’s syndrome.
•3\. Use of any other investigational drugs within 30 days prior to screening (or within 5 half\-lives or until the expected PD effect has returned to baseline, whichever is longer).
•4\. Requiring treatment with any biological medicinal product during the study other than the study medication.
•5\. Treatment with any biologics for any indication since the start of last treatment with either Rituxan®/MabThera®.
•6\. History of severe hypersensitivity to either Rituxan®/MabThera® or any of its excipients, requiring drug discontinuation.
•7\. Any contraindication to Rituxan®/MabThera® or MTX.
•8\. Therapy with any DMARDs (including tofacitinib) other than MTX or combination of MTX with hydroxychloroquine or MTX with chloroquine or MTX with sulfasalazine within 4 weeks prior to randomization. In case of leflunomide it has to be discontinued 8 weeks prior to randomization (if a cholestyramine washout is performed, leflunomide has to be discontinued 4 weeks prior to randomization).
•9\. Previous treatment with any cell depleting therapies, including investigational agents.
•10\. Current treatment or need for treatment with any prohibited medications.