Remicade Safety Line (Ankylosing Spondylitis)(Study P03275)(COMPLETED)

NCT ID: NCT00818168

Last Updated: 2015-09-03

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

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-07-31

Study Completion Date

2010-12-31

Brief Summary

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This observational study is in line with the German educational plan with the aim to implement a tool to increase and monitor the awareness of tuberculosis screening and to reinforce the patient eligibility for a treatment with Remicade according to the Summary of Product Characteristics (SmPc).

Detailed Description

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This study population was chosen from a non-probability sample.

Conditions

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Spondylitis, Ankylosing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Infliximab

Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)

Infliximab

Intervention Type BIOLOGICAL

Dosage and infusion intervals were employed in

accordance to the Summary of Product Characteristics (SmPC)

Interventions

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Infliximab

Dosage and infusion intervals were employed in

accordance to the Summary of Product Characteristics (SmPC)

Intervention Type BIOLOGICAL

Other Intervention Names

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Remicade SCH 215596

Eligibility Criteria

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Inclusion Criteria

* Subjects with ankylosing spondylitis.

Exclusion Criteria

* As per Summary of Product Characteristics (SmPC)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centocor, Inc.

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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P03275

Identifier Type: -

Identifier Source: org_study_id

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