A Retrospective, Observational Chart Review of Biologics in Monotherapy Versus the Combination Biologic Plus Methotrexate in Patients With Rheumatoid Arthritis

NCT ID: NCT01866150

Last Updated: 2015-10-05

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

476 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-03-31

Brief Summary

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This cross-sectional, non-interventional, retrospective chart review will compare the efficacy and safety of biologic monotherapy and biologic and methotrexate combination therapy in patients with rheumatoid arthritis who have had an inadequate response to prior treatment with disease-modifying anti-rheumatic drugs including methotrexate. Data will be collected from patients who have been on first-line biologic treatment for at least 6 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

RETROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>/= 18 years of age
* Diagnosis of rheumatoid arthritis by a rheumatologist
* Patients who have responded inadequately to methotrexate or disease-modifying anti-rheumatic drugs (DMARDs) and are being prescribed a biologic in monotherapy or in combination with methotrexate and other classical DMARDs as per NICE guidelines

Exclusion Criteria

* Primary diagnosis of a condition other than rheumatoid arthritis
* Current treatment with a biologic in combination without methotrexate
* Prior treatment with an experimental agent for rheumatoid arthritis
Minimum Eligible Age

18 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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Cambridge, , United Kingdom

Site Status

Chelmsford, , United Kingdom

Site Status

Cosham, , United Kingdom

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Derby, , United Kingdom

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Dudley, , United Kingdom

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Edinburgh, , United Kingdom

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Harlow, , United Kingdom

Site Status

London, , United Kingdom

Site Status

London, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Norwich, , United Kingdom

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Portadown, , United Kingdom

Site Status

Stoke-on-Trent, , United Kingdom

Site Status

Truro, , United Kingdom

Site Status

Wigan, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ML28642

Identifier Type: -

Identifier Source: org_study_id

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