A Study to Observe Characteristics of Rheumatoid Arthritis in Patients Using Infliximab (Study P04250)

NCT ID: NCT00705289

Last Updated: 2015-07-30

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

728 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-12-31

Study Completion Date

2008-09-30

Brief Summary

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This 14-week non-interventional study will observe patients with rheumatoid arthritis (RA) who are being treated with infliximab for the first time, in order to learn about their disease characteristics. Patients in this study will be treated for RA with infliximab and in a usual manner as decided by their physician.

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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RA Subjects/ Infliximab 3 mg/kg

Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics \[SPC\] of Remicade®).

Infliximab

Intervention Type BIOLOGICAL

Infliximab used in line with current clinical practice and local guidelines.

Interventions

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Infliximab

Infliximab used in line with current clinical practice and local guidelines.

Intervention Type BIOLOGICAL

Other Intervention Names

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Remicade® SCH 215596

Eligibility Criteria

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Inclusion Criteria

* Subject has been diagnosed with RA
* Physician has decided, with the subject's consent, to begin treatment with infliximab
* Written informed consent form signed by both the subject and the physician.

Exclusion Criteria

* Subjects who have previously been exposed to infliximab
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Westhovens R, van Vollenhoven RF, Boumpas DT, Brzosko M, Svensson K, Bjorneboe O, Meeuwisse CM, Srinivasan S, Gaudin P, Smolen JS, Rahman MU, Nelissen RL, Vastesaeger N. The early clinical course of infliximab treatment in rheumatoid arthritis: results from the REMARK observational study. Clin Exp Rheumatol. 2014 May-Jun;32(3):315-23. Epub 2014 Feb 11.

Reference Type RESULT
PMID: 24529163 (View on PubMed)

Other Identifiers

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P04250

Identifier Type: -

Identifier Source: org_study_id

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