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

Remicade Safety Line (Crohn's Disease)

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).

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Biological: Remicade (infliximab)

• Study Type: Observational
• Enrollment (Actual): 148

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with Crohn's disease.

Description

Inclusion Criteria:

• Subjects with Crohn's disease.

Exclusion Criteria:

• As per SmPC

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Remicade (infliximab); Participants with confirmed diagnosis of active Crohn's disease.

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).; Other Names: Remicade; SCH 215596

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment	In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Mendel Mantoux test (tuberculin sensitivity skin test by intradermal injection) as the first screening test was presented in three categories: Yes; No; Missing (represents no entry, but may mean another test was performed as first screening test and documented)	Baseline
Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment	In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Tine test (multiple puncture tuberculin skin test) as the first screening test was presented in three categories: Yes; No; Missing (represents no entry, but may mean another test was performed as first screening test and documented)	Baseline
Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment	In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the in-vitro TB test (cellular blood test, i.e. gamma interferon release assays) as the first screening test was presented in three categories: Yes; No; Missing (represents no entry, but may mean another test was performed as first screening test and documented)	Baseline
Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment	In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). If done according to guidelines, complete TB screening comprised a TB screeing test and a chest X-ray. The number of participants who had a frontal chest X-ray was presented in three categories: Yes; No; Missing	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Disease Activity by Means of the Crohn's Disease Activity Index (CDAI) at the Time of Enrollment and at the First Infusion	The CDAI score is used to quantify the symptoms of participants with CD. The CDAI incorporates 8 items added together that are indicators of disease severity. Scores range from 0 to 600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill. A decrease in CDAI over time indicates improvement in disease activity. CDAI was calculated at the time of enrollment (baseline) and at the time of first infusion.	Baseline and time of first Infusion

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Collaborators: Centocor, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2002
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: January 6, 2009
• First Submitted That Met QC Criteria: January 6, 2009
• First Posted (Estimate): January 7, 2009

Study Record Updates

• Last Update Posted (Estimate): September 3, 2015
• Last Update Submitted That Met QC Criteria: September 2, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Antirheumatic Agents; Gastrointestinal Agents; Dermatologic Agents; Infliximab
• Other Study ID Numbers: P03288