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Remicade Safety Line (Crohn's Disease)(Study P03288)(COMPLETED)

NCT00818272 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 148

Last updated 2015-09-03

Study results available
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Summary

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

Conditions

Interventions

BIOLOGICAL

Remicade (infliximab)

Participants with confirmed diagnosis of severe active Crohn's disease (CD) and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of infliximab therapy with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2010-12-31
Completion
2010-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00818272 on ClinicalTrials.gov