Rituximab in Rheumatoid Arthritis in patients who failed therapy with tumour necrosis factor-blockers: a multi-centre clinical observational real-life study (phase IIIb)

Medical University of Vienna (Austria)0 sites20 target enrollmentStarted: December 21, 2006Last updated: January 13, 2015

Overview

No summary available.

•1\. Women or men 18 years of age or older
•2\. Diagnosis of RA according to the revised 1987 criteria of the American Rheumtololgy Association (ARA) for at least three months prior to first administration of study medication
•3\. The current treatment with Etanercept, Infliximab or Adalimumab in combination with MTX is insufficient. The patient?s disease is considered to be active despite Disease Modifying Anti\-Rheumatic Drug (DMARD) treatment
•4\. Active disease at the time of screening as defined by:
•a. more than or equal to six swollen joints on a 66/68 joint count
•b. more than or equal to six tender joints on a 66/68 joint count
•c. and one out of the following three categories:
•i. Erythrocyte Sedimentation Rate (ESR) more than or equal to 28 mm/h
•ii. C\-Reactive Protein (CRP) more than or equal to 1\.5 mg/dl
•iii. Morning stiffness more than or equal to 45 minutes

•Patients are excluded if they meet one of the following criteria:
•1\. Pregnant women, nursing mothers or a planned pregnancy within six months after last scheduled treatment
•2\. Patients with other inflammatory diseases that might interfere with the evaluation of the RA
•3\. Patients with fibromyalgia syndrome
•4\. Use of IntraMuscular (IM), IntraVenous (IV), IntraArterial (IA) corticosteroids within four weeks prior to screening
•5\. Treatment with any investigational drug within three months prior to screening
•6\. A history of known allergy to murine proteins, e.g. allergy to Infliximab
•7\. History of infected joint prothesis within the previous five years
•8\. Chronic infections
•9\. History of active tuberculosis requiring treatment within the previous three years, or history of opportunistic infections within two months, uncontrolled active infection or documented Human Immunodeficiency Virus (HIV) infection. Also excluded are patients with evidence of latent tuberculosis and patients with old tuberculosis (TB) without documented adequate therapy if they will not be treated according to the local TB guidelines

Sponsor

Medical University of Vienna (Austria)