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

Spondylitis, Ankylosing Clinical Trial

Official title:

Remicade Safety Line (Ankylosing Spondylitis)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00818168
• Other study ID #: P03275
• Status: Completed
• Phase: N/A
• First received: January 6, 2009
• Last updated: September 2, 2015
• Start date: July 2003
• Est. completion date: December 2010

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Observational

Clinical Trial 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 of tuberculosis screening and to reinforce the patient eligibility for a treatment with Remicade according to the Summary of Product Characteristics (SmPc).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with ankylosing spondylitis.

Exclusion Criteria:

• As per Summary of Product Characteristics (SmPC)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Spondylitis
• Spondylitis, Ankylosing

Intervention

Biological:
• Infliximab
Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Centocor, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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; Missing (represents no entry, but may mean another test was performed as first screening test and documented)	Baseline	No
Primary	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; Missing (represents no entry, but may mean another test was performed as first screening test and documented)	Baseline	No
Primary	Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting	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; Missing (represents no entry, but may mean another test was performed as first screening test and documented)	Baseline	No
Primary	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 screening test and a chest X-ray. The number of participants who had a frontal chest X-ray was presented in three categories: Yes; Missing	Baseline	No
Secondary	Assessment of Disease Activity by Means of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at the Time of Enrollment and at the First Infusion	The BASDAI score was calculated based on the responses to questions 1-6, with each component rated on a scale of 0 (best) to 10 (worst) based on the severity of various characteristics. A decrease in BASDAI over time indicated improvement in disease activity. The score corresponded to the sum of the point values from questions 1-4 and the mean of the point values from questions 5 and 6, subsequently divided by five. BASDAI was calculated at the time of enrollment (baseline) and at the time of first infusion.	Baseline and time of first infusion	No