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

NCT00724958 | Completed Results

• 1 other identifier: P04052
• Study Type: observational
• Target: 348
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (5)

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

  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).

  up to 2 years

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

  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).

  up to 2 years

• Average Dose of Infliximab Per Participant Within the Observation Period

  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).

  up to 2 years

• Median Dose of Infliximab Per Participant Within the Observation Period

  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).

  up to 2 years

• Total Dose of Infliximab Per Participant Within the Observation Period

  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).

  up to 2 years

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.

  5 years

Study Arms (1)

Remicade

Subjects with active luminal and/or fistulizing CD in the hospital or non-hospital setting.

Biological: Infliximab

Interventions

Infliximab BIOLOGICAL

Not specified in the protocol.

Also known as: Remicade, SCH 215596

Remicade

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with active luminal and/or fistulizing CD who are treated with Remicade in the hospital and non-hospital setting.

You may qualify if:

• Subjects with active luminal and/or fistulizing CD.

You may not qualify if:

• Per summary of product characteristics.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Centocor, Inc.: collaborator

MeSH Terms

Conditions

Crohn Disease

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 30, 2008
• Study Start: December 1, 2004
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 2, 2015
• Results First Posted: October 26, 2011

Record last verified: 2015-10