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

NCT ID: NCT01283399

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2014-04-30

Brief Summary

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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.

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 + 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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

21 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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Beirut, , Lebanon

Site Status

Beirut, , Lebanon

Site Status

Beirut, , Lebanon

Site Status

Byblos, , Lebanon

Site Status

Tripoli, , Lebanon

Site Status

Countries

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Lebanon

Other Identifiers

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ML25270

Identifier Type: -

Identifier Source: org_study_id