An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy

NCT ID: NCT01592292

Last Updated: 2016-08-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-12-31

Brief Summary

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This prospective, multi-center, observational study will evaluate the efficacy and the safety of MabThera (rituximab) in participants with rheumatoid arthritis who have not responded or have been intolerant to a first anti-TNF alpha therapy. Participants have commenced MabThera or an alternative anti-TNF alpha treatment as a second biological therapy. Data will be collected for 12 months.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rituximab

Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.

Rituximab

Intervention Type DRUG

Rituximab as per physician's discretion.

Other anti-TNF agent

Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent, including adalimumab, etanercept and infliximab, as per physician's discretion for RA treatment were observed for 12 months.

Adalimumab

Intervention Type DRUG

Adalimumab as per physician's discretion.

Etanercept

Intervention Type DRUG

Etanercept as per physician's discretion.

Infliximab

Intervention Type DRUG

Infliximab as per physician's discretion.

Interventions

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Rituximab

Rituximab as per physician's discretion.

Intervention Type DRUG

Adalimumab

Adalimumab as per physician's discretion.

Intervention Type DRUG

Etanercept

Etanercept as per physician's discretion.

Intervention Type DRUG

Infliximab

Infliximab as per physician's discretion.

Intervention Type DRUG

Other Intervention Names

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Mabthera

Eligibility Criteria

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Inclusion Criteria

* Adult participants, \>/=20 years of age
* Participants with rheumatoid arthritis, who have not responded or have been intolerant to a single anti-TNF alpha therapy and who have initiated MabThera or an alternative anti-TNF alpha therapy

Exclusion Criteria

* Participants whose first anti-TNF alpha treatment was, or second biological therapy is given as part of a clinical trial studying rheumatoid arthritis
* Participants who have not signed the informed consent form
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Busan, , South Korea

Site Status

Daegu, , South Korea

Site Status

Daegu, , South Korea

Site Status

Daejeon, , South Korea

Site Status

Gwangju, , South Korea

Site Status

Gyeonggi-do, , South Korea

Site Status

Jeju Special Self-Governing Province, , South Korea

Site Status

Jeollabuk-do, , South Korea

Site Status

Seoul, , South Korea

Site Status

Seoul, , South Korea

Site Status

Seoul, , South Korea

Site Status

Seoul, , South Korea

Site Status

Seoul, , South Korea

Site Status

Suwon, , South Korea

Site Status

Ulsan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ML27923

Identifier Type: -

Identifier Source: org_study_id

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