A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417)

NCT ID: NCT00741104

Last Updated: 2017-01-04

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

363 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-06-30

Brief Summary

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This observational study will explore the Swedish national population of patients with rheumatoid arthritis (RA) on infliximab maintenance therapy in order to identify patients who may be eligible for a dose reduction study. Patients will be asked a variety of questions regarding their treatment dosing and disease activity, and then asked whether or not they would consider participating in a dose reduction study. Patients in this study will be described in terms of demographic and disease characteristics.

Detailed Description

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Already known Subjects (RA and on at least 12 months ongoing Remicade treatment) from the clinic could participate if they are eligible.

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 patients

Patients on maintenance therapy for RA with infliximab for \>= the past 12 months.

Infliximab

Intervention Type DRUG

Treatment of RA with Infliximab according to and under normal routine clinical practice.

Interventions

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Infliximab

Treatment of RA with Infliximab according to and under normal routine clinical practice.

Intervention Type DRUG

Other Intervention Names

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Remicade SCH 215596

Eligibility Criteria

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Inclusion Criteria

* Rheumatoid arthritis, infliximab maintenance treatment for at least the past 12 months, given written informed consent.

Exclusion Criteria

* episodic treatment with 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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Breynaert C, Ferrante M, Fidder H, Van Steen K, Noman M, Ballet V, Vermeire S, Rutgeerts P, Van Assche G. Tolerability of shortened infliximab infusion times in patients with inflammatory bowel diseases: a single-center cohort study. Am J Gastroenterol. 2011 Apr;106(4):778-85. doi: 10.1038/ajg.2011.61. Epub 2011 Mar 15.

Reference Type RESULT
PMID: 21407184 (View on PubMed)

Other Identifiers

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P05417

Identifier Type: -

Identifier Source: org_study_id

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