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Completed

NCT Number: NCT00725621

Real Life Dosing of Remicade for Rheumatoid Arthritis in Austria Monitored Over 9 Infusions (Study P03756)(COMPLETED)

This is a prospective, open-label, 1-arm, multicenter observational study to determine the average Remicade dosage and time span between 9 infusions in subjects with rheumatoid arthritis (RA)

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

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

  • Severe RA (indication according to Austrian labeling).

Exclusion criteria

  • According to Summary of Product Characteristics (SPC).

Treatment and study plan

Infliximab

Biological

Remicade induction therapy consisting of three Remicade infusions in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy will consist of another maximal 6 infusions given in doses and intervals due to discretion of physicians.

Other names: Remicade, SCH 215596

Primary outcomes

  1. Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy

    Time frame: Maximum of 16 weeks

    The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.

  2. Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy

    Time frame: Maximum of 16 weeks

    The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.

  3. Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy

    Time frame: Maximum of 102 weeks

    The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.

  4. Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy

    Time frame: Maximum of 102 weeks

    The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.

  5. Mean Remicade Dose Per Participant

    Time frame: Maximum of 102 weeks

  6. Median Remicade Dose Per Participant

    Time frame: Maximum of 102 weeks

Secondary outcomes

  1. Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy

    Time frame: 24 months maximum

  2. Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

    Time frame: 24 months maximum

    Some participants had more than one previous treatment with a DMARD.

  3. Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS)

    Time frame: 24 months maximum

    Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS & the Mental Component Summary Score (MCS). The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.

  4. Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS

    Time frame: 24 months maximum

    Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS & the MCS. The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Centocor, Inc.

Registry information

Official study title

Real Life Dosing Regimen of Remicade in Austria, Monitored Over 9 Consecutive Infusions in Rheumatoid Arthritis Therapy

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Jul 30, 2008
Registry last updated
Sep 3, 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.

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