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OpenTrials
Completed

NCT Number: NCT02564770

A Retrospective Chart Review of MabThera (Rituximab) Treatment in Rheumatoid Arthritis (RA) Participants in Australia

This is a cross-sectional, observational study examining the factors leading to the therapeutic decision to use MabThera (rituximab) in participants with RA. Routine rheumatology clinical practice data of participants who are being or have been treated with rituximab for RA will be collected and analysed in this chart review.

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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

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Geelong, Victoria, 3220, Australia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Greater than or equal to (>=) 18 years of age at the time of data collection
  • RA diagnosed by a rheumatologist
  • Treatment with rituximab for RA

Exclusion criteria

  • Participants whose primary diagnosis and indication for rituximab treatment is a condition other than RA
  • Participants who have been treated with an experimental agent for RA which is not currently approved for the treatment of RA in Australia

Treatment and study plan

Primary outcomes

  1. Factors leading to Therapeutic decision to use rituximab

    Time frame: Up to end of study (approximately 1 month)

Secondary outcomes

  1. Change in Erythrocyte sedimentation rate

    Time frame: Baseline and most recent visits (approximately 1 month)

  2. Change in Immunoglobulin levels

    Time frame: Baseline and most recent visits (approximately 1 month)

  3. Percentage of participants with positive or negative results for rheumatoid factor

    Time frame: Up to end of study (approximately 1 month)

  4. Percentage of participants with positive or negative results for anti-cyclic citrullinated peptide antibody

    Time frame: Up to end of study (approximately 1 month)

  5. Percentage of participants with positive or negative results for anti-nuclear antibodies

    Time frame: Up to end of study (approximately 1 month)

  6. Disease activity score (DAS28)

    Time frame: At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)

  7. Tender joint count (TJC)

    Time frame: At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)

  8. Swollen joint count (SJC)

    Time frame: At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)

  9. Duration of treatment with rituximab

    Time frame: From first dose to most recent rituximab infusion (approximately 1 month)

  10. Change in C-reactive protein

    Time frame: Baseline and most recent visits (approximately 1 month)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Collaborators

  • Roche Products Pty Ltd (Australia)

Registry information

Official study title

A Retrospective Chart Review of the Use of MabThera (Rituximab) for the Treatment of Rheumatoid Arthritis (RA) in Australian Rheumatology Practice

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 1, 2015
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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