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

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Infliximab

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
• Enrollment (Actual): 363

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• episodic treatment with infliximab

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosing Interval Between the Infliximab Infusions	Patients were asked as part of the Remicade questionnaire what dosing interval they were on.	Measured from the Remicade Questionnaire at first (and only) study visit
Reason for Extending Dosing Interval	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.	Measured from the Remicade Questionnaire at first (and only) study visit
Patient Response to Increased Dosing Interval	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.	Measured from the Remicade Questionnaire at first (and only) study visit
Number of Patients Agreeing to Participate in a Dose Reduction Study	As part of the Remicade questionnaire, patients were asked "would you consider participating in a dose reduction study?"	Measured from the Remicade Questionnaire at first (and only) study visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Activity Score Based on Assessment of 28 Joints (DAS28), Health Assessment Questionnaire (HAQ), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Infliximab Dosage.	This is not a prespecified key secondary outcome; therefore, results will not be disclosed	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.
Adverse Events (AEs)	This is not a prespecified key secondary outcome; therefore, results will not be disclosed	Collected at first (and only) study visit, all AEs reported during the previous 12 months is collected from the Swedish Rheumatoid Arthritis (RA) Registry.
Duration of Subject's Rheumatoid Arthritis (RA) Diagnosis, European Quality of Life Group 1990 5 Dimension (EQ5D) and Patient Remicade Questionnaire.	This is not a prespecified key secondary outcome; therefore, results will not be disclosed	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.

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Breynaert C, Ferrante M, Fidder H, Van Steen K, Noman M, Ballet V, Vermeire S, Rutgeerts P, Van Assche G. Tolerability of shortened infliximab infusion times in patients with inflammatory bowel diseases: a single-center cohort study. Am J Gastroenterol. 2011 Apr;106(4):778-85. doi: 10.1038/ajg.2011.61. Epub 2011 Mar 15.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: July 30, 2008
• First Submitted That Met QC Criteria: August 22, 2008
• First Posted (Estimate): August 26, 2008

Study Record Updates

• Last Update Posted (Estimate): January 4, 2017
• Last Update Submitted That Met QC Criteria: January 2, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Antirheumatic Agents; Gastrointestinal Agents; Dermatologic Agents; Infliximab
• Other Study ID Numbers: P05417