Clinical trial NCT00741104: A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417)
Official title: A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-08-26
Enrollment: 363
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are Swedish patients on maintenance therapy for RA with infliximab for \>= the past 12 months.

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.

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

Eligibility 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

Primary outcomes:
measure: Dosing Interval Between the Infliximab Infusions
timeFrame: Measured from the Remicade Questionnaire at first (and only) study visit
measure: Reason for Extending Dosing Interval
timeFrame: Measured from the Remicade Questionnaire at first (and only) study visit
measure: Patient Response to Increased Dosing Interval
timeFrame: Measured from the Remicade Questionnaire at first (and only) study visit
measure: Number of Patients Agreeing to Participate in a Dose Reduction Study
timeFrame: Measured from the Remicade Questionnaire at first (and only) study visit
Secondary outcomes:
measure: Disease Activity Score Based on Assessment of 28 Joints (DAS28), Health Assessment Questionnaire (HAQ), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Infliximab Dosage.
timeFrame: 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.
measure: Adverse Events (AEs)
timeFrame: Collected at first (and only) study visit, all AEs reported during the previous 12 months is collected from the Swedish Rheumatoid Arthritis (RA) Registry.
measure: Duration of Subject's Rheumatoid Arthritis (RA) Diagnosis, European Quality of Life Group 1990 5 Dimension (EQ5D) and Patient Remicade Questionnaire.
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
References:
citation: 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.