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Completed

NCT Number: NCT02322801

Observational Safety Study of Rituximab in Patients Diagnosed With Rheumatoid Arthritis (RA) Who Did Not Respond Adequately to TNF-alpha Blocker

This multi-center, observational, retrospective-prospective cohort study will investigate the safety of rituximab (MabThera) by collecting data from daily clinical practice on the use of rituximab and its relative clinical impact, particularly with regard to adverse events. Data from each patient will be collected over 24 months after enrolment in the study. Target sample size is up to 325 patients.

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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

Pescara, Abruzzo, Italy

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed with RA who did not respond adequately to anti-TNF-alpha and who started rituximab (RTX) treatment in the 12 months before site initiation and were still under treatment when enrollment starts

Exclusion criteria

  • Patients with serious infections

Treatment and study plan

Primary outcomes

  1. Percent of patients with at least one grade 3 or 4 adverse event since starting RTX treatment and in the 24 months after study enrollment

    Time frame: Up to 31 months (24 months each patient)

Secondary outcomes

  1. Percent of patients with at least one severe adverse event (SAE)

    Time frame: Up to 31 months (24 months each patient)

  2. Percent of patients who discontinued therapy with RTX

    Time frame: Up to 31 months (24 months each patient)

  3. Time to "re-treatment" with RTX

    Time frame: Up to 31 months (24 months each patient)

  4. Features of responders to RTX therapy in terms of co-morbidity and concomitant drugs

    Time frame: Up to 31 months (24 months each patient)

  5. Time to response and duration of response to RTX

    Time frame: Up to 31 months (24 months each patient)

  6. Percent of patients who achieve remission and relative quality of life (QoL) at 6, 12 and 24 months versus baseline

    Time frame: Up to 31 months (24 months each patient)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 23, 2014
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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