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An Observational Study of Rituximab in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01283399
First received: January 24, 2011
Last updated: September 1, 2016
Last verified: September 2016
  Purpose
This observational study will assess the efficacy and safety of combination of rituximab (MabThera) and methotrexate in participants with active refractory rheumatoid arthritis (RA) who have failed to respond to a single course of anti-tumor necrosis factor (TNF) therapy in routine clinical practice. Data will be collected from participants for 12 months after the first dose of rituximab or a minimum of 6 months following a rituximab 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:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Disease Activity Score Based on 28-joints Count (DAS28) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reasons for Re-treatment With Rituximab Within 6 Months of the First Treatment [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Disease Activity Score Based on 28-joints Count (DAS28) 6 Months After the Re-treatment With Rituximab [ Time Frame: 6 Months After the Re-treatment With Rituximab (up to 5 years) ] [ Designated as safety issue: No ]
  • Demographics of Participants Eligible to Receive Rituximab [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Number of Participants With Adverse Events [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 79
Study Start Date: August 2010
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Rituximab + Methotrexate
All participants with active refractory RA who were eligible to receive treatment with methotrexate and rituximab in the Investigators' opinion as per the routine clinical practice following inadequate response to a single cycle of anti-TNF therapy.

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All participants with active refractory RA who were eligible to receive treatment with methotrexate and rituximab in the Investigators' opinion as per the routine clinical practice following inadequate response to a single cycle of anti-TNF therapy.
Criteria

Inclusion Criteria:

  • Active rheumatoid arthritis
  • Inadequate response to a single TNF inhibitor
  • Participants receiving rituximab therapy in accordance with the prescribing information
  • Signed data release form within 6 weeks (42 days) of initiating rituximab therapy
  • Women of childbearing potential must use effective form of contraception

Exclusion Criteria:

  • Contra-indication to receive rituximab according to the local labelling
  • Previous treatment with rituximab
  • Treatment with any investigational drug within 30 days prior to enrolment
  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: NCT01283399

Locations
Lebanon
Beirut, Lebanon, 11-236
Beirut, Lebanon, 99999
Beirut, Lebanon
Jbeil, Lebanon, 1401
Tripoli, Lebanon, 371 Tripoli
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

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: September 1, 2016
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
Rituximab
Methotrexate
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 27, 2016