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Completed

NCT Number: NCT01283399

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beirut, Lebanon

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Disease Activity Score Based on 28-joints Count (DAS28)

    Time frame: Up to 5 years

Secondary outcomes

  1. Reasons for Re-treatment With Rituximab Within 6 Months of the First Treatment

    Time frame: Up to 5 years

  2. 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)

  3. Demographics of Participants Eligible to Receive Rituximab

    Time frame: Baseline

  4. Number of Participants With Adverse Events

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Non-interventional Multicenter Study of MabThera® (Rituximab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jan 26, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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