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

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00818168
First received: January 6, 2009
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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).


Condition Intervention
Spondylitis, Ankylosing
Biological: Infliximab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Remicade Safety Line (Ankylosing Spondylitis)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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)

  • Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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)

  • Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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)

  • Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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
    • No
    • Missing


Secondary Outcome Measures:
  • 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 [ Time Frame: Baseline and time of first infusion ] [ Designated as safety issue: No ]
    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.


Enrollment: 320
Study Start Date: July 2003
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Infliximab
Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
Biological: Infliximab

Dosage and infusion intervals were employed in

accordance to the Summary of Product Characteristics (SmPC)

Other Names:
  • Remicade
  • SCH 215596

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with ankylosing spondylitis.

Criteria

Inclusion Criteria:

  • Subjects with ankylosing spondylitis.

Exclusion Criteria:

  • As per Summary of Product Characteristics (SmPC)
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00818168     History of Changes
Other Study ID Numbers: P03275
Study First Received: January 6, 2009
Results First Received: December 22, 2011
Last Updated: October 10, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 14, 2014