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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01641952
First received: July 13, 2012
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This observational, prospective, multicenter study will evaluate the efficacy an d safety of MabThera/Rituxan in patients with active rheumatoid arthritis and a n inadequate response or intolerance to one anti-TNF therapy. Patients who recei ve MabThera/Rituxan according to the current standard and in line with the summa ry of product characteristics at a dose of 1000 mg intravenously on Days 1 and 1 5 will be followed for 20 weeks.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean change in Disease Activity Score (DAS28-ESR) at Week 20 [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life: Health Assessment Questionnaire [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with active rheumatoid arthritis and an inadequate response or intolerant to one prior anti-TFN therapy initiated on treatment with MabThera/Rituxan

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01641952

Contacts
Contact: Reference Study ID Number: ML27953 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Romania
Recruiting
Bucuresti, Romania, 020983
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01641952     History of Changes
Other Study ID Numbers: ML27953
Study First Received: July 13, 2012
Last Updated: July 7, 2014
Health Authority: Romania: Romanian National Medicine and Medical Devices Agency

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 29, 2014