Skip to main content
OpenTrials
Completed

NCT Number: NCT00725296

Investigation of 9 Consecutive Infusions of Remicade for Psoriatic Arthritis in Austria (Study P04264)

This is a prospective, open-label, 1-arm, multicenter observational study to determine the dose and time interval of Remicade (Infliximab) infusions in psoriatic arthritis (PsA).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arthritis, Psoriatic Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

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

  • Participants with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drugs.

Exclusion criteria

  • All according to contraindications in the label especially:
  • Participants with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections.
  • Participants with moderate or severe heart failure (NYHA class III/IV).
  • Participants with a history of hypersensitivity to infliximab or to other murine proteins, or to any of the excipients.

Treatment and study plan

Remicade (Infliximab)

Biological

Induction infusions of Remicade will be administered at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians. A maximum of 6 maintenance infusions will be administered with the dosage and interval due to the discretion of the physicians.

Other names: Remicade, SCH 215596

Primary outcomes

  1. Mean Time Interval Between Infusions During Maintenance Therapy

    Time frame: Up to 24 months

    The mean time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.

  2. Median Time Interval Between Infusions During Maintenance Therapy

    Time frame: Up to 24 months

    The median time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.

  3. Average Dose During Induction Therapy and Subsequent Maintenance Therapy

    Time frame: Up to 24 Months

    The average dose per infusion measured in milligrams/killogram (mg/kg) in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions).

  4. Median Dose During Induction Therapy and Subsequent Maintenance Therapy

    Time frame: Up to 24 Months

    The median dose per infusion measured in mg/kg in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions).

  5. Average Overall Dose of All Infusions Per Participant

    Time frame: Up to 24 Months

    The average overall dose of all infusions among all Infliximab-naive participants measured in mg/kg.

  6. Median Dose of All Infusions Per Participant

    Time frame: Up to 24 Months

    The median dose of all infusions among all Infliximab-naive participants measured in mg/kg.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Centocor, Inc.

Registry information

Official study title

Remicade Therapy in Psoriatic Arthritis: Investigation of Real Life Regimen in Austria Over 9 Consecutive Infusions

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Jul 30, 2008
Registry last updated
Nov 5, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.