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

Rheumatoid Arthritis Clinical Trial

— REQUEST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741104
• Other study ID #: P05417
• Status: Completed
• Phase: Phase 4
• First received: July 30, 2008
• Last updated: January 2, 2017
• Start date: January 2008
• Est. completion date: June 2008

Study information

• Verified date: January 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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.	No
Secondary	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.	Yes
Secondary	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.	No