An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-TNF Agent

Rheumatoid Arthritis Clinical Trial

Official title:

Non-interventional, Prospective, Multicenter Study to Assess Efficacy and Safety of MabtheRA (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One Anti-TNF Agent - FAST 2 SWITCH Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01641952
• Other study ID #: ML27953
• Status: Completed
• Phase: N/A
• First received: July 13, 2012
• Last updated: April 2, 2016
• Start date: October 2011
• Est. completion date: January 2015

Study information

• Verified date: April 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Romanian National Medicine and Medical Devices Agency
• Study type: Observational

Clinical Trial Summary

This observational, prospective, multicenter study will evaluate the efficacy and safety of MabThera/Rituxan in patients with active rheumatoid arthritis and an inadequate response or intolerance to one anti-TNF therapy. Patients who receive MabThera/Rituxan according to the current standard and in line with the summary of product characteristics at a dose of 1000 mg intravenously on Days 1 and 15 will be followed for 20 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 505
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Patients with rheumatoid arthritis, eligible for treatment with MabThera/Rituxan in accordance with SPC

• Inadequate response to a single TNF inhibitor defined as change in DAS28-ESR <1.2 or DAS28-ESR >3.5 at 5 months after first course of anti-TNF therapy

• Patients with a clinical and biological evaluation performed within 12 weeks prior to enrolment may be included

Exclusion Criteria:

• More than one previous anti-TNF therapies

• Any other biological therapy apart from the one anti-TNF therapy

• Hypersensitivity to rituximab or any of the excipients or to murine proteins

• Active severe infections

• Patients in a severely immunocompromised state

• Severe heart failure (NYHA Class IV) or severe, uncontrolled cardiac disease

• Women of childbearing potential not willing to use contraception

• Pregnant or breastfeeding women

• Participation in another trial

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in Disease Activity Score (DAS28-ESR) at Week 20		approximately 2 years	No
Primary	Safety: Incidence of adverse events		approximately 2 years	No
Secondary	Quality of life: Health Assessment Questionnaire		approximately 2 years	No