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

NCT00725296 | Completed Results

• 1 other identifier: P04264
• Study Type: observational
• Target: 178
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Arthritis, Psoriatic

Outcome Measures

Primary Outcomes (6)

• Mean Time Interval Between Infusions During Maintenance Therapy

  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.

  Up to 24 months

• Median Time Interval Between Infusions During Maintenance Therapy

  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.

  Up to 24 months

• Average Dose During Induction Therapy and Subsequent Maintenance Therapy

  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).

  Up to 24 Months

• Median Dose During Induction Therapy and Subsequent Maintenance Therapy

  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).

  Up to 24 Months

• Average Overall Dose of All Infusions Per Participant

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

  Up to 24 Months

• Median Dose of All Infusions Per Participant

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

  Up to 24 Months

Study Arms (1)

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)

Interventions

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.

Also known as: Remicade, SCH 215596

Remicade (Infliximab)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Centocor, Inc.: collaborator

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Infliximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 30, 2008
• Study Start: December 1, 2004
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: November 5, 2015
• Results First Posted: July 29, 2011

Record last verified: 2015-10