Skip to main content
OpenTrials
Completed

NCT Number: NCT00741104

A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417)

This observational study will explore the Swedish national population of patients with rheumatoid arthritis (RA) on infliximab maintenance therapy in order to identify patients who may be eligible for a dose reduction study. Patients will be asked a variety of questions regarding their treatment dosing and disease activity, and then asked whether or not they would consider participating in a dose reduction study. Patients in this study will be described in terms of demographic and disease characteristics.

Completed

Looking for future studies?

Notify Me

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

Already known Subjects (RA and on at least 12 months ongoing Remicade treatment) from the clinic could participate if they are eligible.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Rheumatoid arthritis, infliximab maintenance treatment for at least the past 12 months, given written informed consent.

Exclusion criteria

  • episodic treatment with infliximab

Treatment and study plan

Infliximab

Drug

Treatment of RA with Infliximab according to and under normal routine clinical practice.

Other names: Remicade, SCH 215596

Primary outcomes

  1. Dosing Interval Between the Infliximab Infusions

    Time frame: Measured from the Remicade Questionnaire at first (and only) study visit

    Patients were asked as part of the Remicade questionnaire what dosing interval they were on.

  2. Reason for Extending Dosing Interval

    Time frame: Measured from the Remicade Questionnaire at first (and only) study visit

    Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, the reason for extending dosing interval was asked of each patient.

  3. Patient Response to Increased Dosing Interval

    Time frame: Measured from the Remicade Questionnaire at first (and only) study visit

    Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, patients were asked "did you notice any difference when your dosing interval was extended?" Those who noticed a difference were asked if their experience was positive or negative.

  4. Number of Patients Agreeing to Participate in a Dose Reduction Study

    Time frame: Measured from the Remicade Questionnaire at first (and only) study visit

    As part of the Remicade questionnaire, patients were asked "would you consider participating in a dose reduction study?"

Secondary outcomes

  1. Disease Activity Score Based on Assessment of 28 Joints (DAS28), Health Assessment Questionnaire (HAQ), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Infliximab Dosage.

    Time frame: Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.

    This is not a prespecified key secondary outcome; therefore, results will not be disclosed

  2. Adverse Events (AEs)

    Time frame: Collected at first (and only) study visit, all AEs reported during the previous 12 months is collected from the Swedish Rheumatoid Arthritis (RA) Registry.

    This is not a prespecified key secondary outcome; therefore, results will not be disclosed

  3. Duration of Subject's Rheumatoid Arthritis (RA) Diagnosis, European Quality of Life Group 1990 5 Dimension (EQ5D) and Patient Remicade Questionnaire.

    Time frame: Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.

    This is not a prespecified key secondary outcome; therefore, results will not be disclosed

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients

Acronym: REQUEST

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 26, 2008
Registry last updated
Jan 4, 2017

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.