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

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00725296
First received: July 25, 2008
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention
Arthritis, Psoriatic
Biological: Remicade (Infliximab)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Remicade Therapy in Psoriatic Arthritis: Investigation of Real Life Regimen in Austria Over 9 Consecutive Infusions

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Mean Time Interval Between Infusions During Maintenance Therapy [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    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.

  • Median Time Interval Between Infusions During Maintenance Therapy [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    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.

  • Average Dose During Induction Therapy and Subsequent Maintenance Therapy [ Time Frame: Up to 24 Months ] [ Designated as safety issue: No ]
    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).

  • Median Dose During Induction Therapy and Subsequent Maintenance Therapy [ Time Frame: Up to 24 Months ] [ Designated as safety issue: No ]
    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).

  • Average Overall Dose of All Infusions Per Participant [ Time Frame: Up to 24 Months ] [ Designated as safety issue: No ]
    The average overall dose of all infusions among all Infliximab-naive participants measured in mg/kg.

  • Median Dose of All Infusions Per Participant [ Time Frame: Up to 24 Months ] [ Designated as safety issue: No ]
    The median dose of all infusions among all Infliximab-naive participants measured in mg/kg.


Enrollment: 178
Study Start Date: December 2004
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Remicade (Infliximab)
Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs will receive induction infusions of Remicade 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. Whole observation period cannot exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in the Summary of Product Characteristics (SPC) is taken into consideration.
Biological: Remicade (Infliximab)
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

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants will receive Remicade induction therapy consisting of 3 infusions in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy will consist of a maximum of 6 infusions given in doses and intervals due to the discretion of physicians.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00725296     History of Changes
Other Study ID Numbers: P04264
Study First Received: July 25, 2008
Results First Received: July 1, 2011
Last Updated: April 28, 2014
Health Authority: Austria: No HA submission required

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Infliximab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014