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

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ClinicalTrials.gov Identifier: NCT00725296
Recruitment Status : Completed
First Posted : July 30, 2008
Results First Posted : July 29, 2011
Last Update Posted : November 5, 2015
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment
Arthritis, Psoriatic Biological: Remicade (Infliximab)

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

Study Type : Observational
Actual Enrollment : 178 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Remicade Therapy in Psoriatic Arthritis: Investigation of Real Life Regimen in Austria Over 9 Consecutive Infusions
Study Start Date : December 2004
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab
U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00725296     History of Changes
Other Study ID Numbers: P04264
First Posted: July 30, 2008    Key Record Dates
Results First Posted: July 29, 2011
Last Update Posted: November 5, 2015
Last Verified: October 2015

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
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents