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

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ClinicalTrials.gov Identifier: NCT00741104
Recruitment Status : Completed
First Posted : August 26, 2008
Results First Posted : August 21, 2009
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Infliximab Phase 4

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

Study Type : Observational
Actual Enrollment : 363 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients
Study Start Date : January 2008
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

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

Group/Cohort Intervention/treatment
RA patients
Patients on maintenance therapy for RA with infliximab for >= the past 12 months.
Drug: Infliximab
Treatment of RA with Infliximab according to and under normal routine clinical practice.
Other Names:
  • Remicade
  • SCH 215596



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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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
Subjects are Swedish patients on maintenance therapy for RA with infliximab for >= the past 12 months.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • episodic treatment with infliximab

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00741104     History of Changes
Other Study ID Numbers: P05417
First Posted: August 26, 2008    Key Record Dates
Results First Posted: August 21, 2009
Last Update Posted: January 4, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents