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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT00741104
Date of registration: 30/07/2008
Prospective Registration: Yes
Primary sponsor: Merck Sharp & Dohme Corp.
Public title: A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417) REQUEST
Scientific title: A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients
Date of first enrolment: January 2008
Target sample size: 363
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00741104
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Contacts
Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Infliximab
Primary Outcome(s)
Dosing Interval Between the Infliximab Infusions [Time Frame: Measured from the Remicade Questionnaire at first (and only) study visit]
Number of Patients Agreeing to Participate in a Dose Reduction Study [Time Frame: Measured from the Remicade Questionnaire at first (and only) study visit]
Patient Response to Increased Dosing Interval [Time Frame: Measured from the Remicade Questionnaire at first (and only) study visit]
Reason for Extending Dosing Interval [Time Frame: Measured from the Remicade Questionnaire at first (and only) study visit]
Secondary Outcome(s)
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.]
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.]
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.]
Secondary ID(s)
P05417
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 21/08/2009
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00741104
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