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Completed

NCT Number: NCT00724958

Program Extension of Real Life Dosing of Remicade in Austria for Crohn's Disease (Study P04052)(COMPLETED)

The current observational program was determined to collect data on the real life dosing regimen of Remicade in patients with Crohn's disease (CD) in the hospital and non-hospital setting.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

This study population was chosen from a non-probability sample

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with active luminal and/or fistulizing CD.

Exclusion criteria

  • Per summary of product characteristics.

Treatment and study plan

Infliximab

Biological

Not specified in the protocol.

Other names: Remicade, SCH 215596

Primary outcomes

  1. Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)

    Time frame: up to 2 years

    Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).

  2. Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)

    Time frame: up to 2 years

    Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).

  3. Average Dose of Infliximab Per Participant Within the Observation Period

    Time frame: up to 2 years

    Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).

  4. Median Dose of Infliximab Per Participant Within the Observation Period

    Time frame: up to 2 years

    Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).

  5. Total Dose of Infliximab Per Participant Within the Observation Period

    Time frame: up to 2 years

    Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).

Secondary outcomes

  1. Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients.

    Time frame: 5 years

    HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). HBI is a score on a scale; <5 (remission), 5-7 (mild disease), 8-16 (moderate disease), >16 (severe disease).

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Centocor, Inc.

Registry information

Official study title

Real Life Dosing Regimen of Remicade in Austria in Crohn's Disease - Program Extension

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Jul 30, 2008
Registry last updated
Oct 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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