Text Size

An Observational Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01283399
First received: January 24, 2011
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

This observational study will assess the efficacy and safety of MabThera (rituximab) in combination with methotrexate in patients with active refractory rheumatoid arthritis who have failed to respond to a single course of anti-TNF therapy in routine clinical practice. Data will be collected from patients for 12 months after the first dose of MabThera or a minimum of 6 months following a re-treatment course.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-interventional Multicenter Study of MabThera® (Rituximab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Efficacy of MabThera (rituximab) plus methotrexate in routine clinical practice following inadequate response to a single cycle of anti-TNF therapy: Disease Activity Score (DAS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reasons for re-treatment with MabThera in case of re-treatment within 6 months of the first course [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Efficacy of MabThera in case of re-treatment after 6 months of the re-treatment course: DAS [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Demographics of patients eligible to receive MabThera [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: August 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (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

Refractory rheumatoid arthritis

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Active rheumatoid arthritis
  • Inadequate response to a single anti-TNF inhibitor
  • Eligible to receive MabThera therapy in accordance with prescribing information
  • Signed data release form
  • Women of childbearing potential must use effective form of contraception

Exclusion Criteria:

  • Contra-indication to receive MabThera according to the local labelling
  • Previous treatment with MabThera
  • Treatment with any investigational drug within 30 days prior to enrolment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283399

Locations
Lebanon
Beirut, Lebanon, 99999
Beirut, Lebanon
Beirut, Lebanon, 11-236
Jbeil, Lebanon, 1401
Tripoli, Lebanon, 371 Tripoli
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: NCT01283399     History of Changes
Other Study ID Numbers: ML25270
Study First Received: January 24, 2011
Last Updated: May 23, 2013
Health Authority: Lebanon: Ministry of Public Health

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Rituximab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013