Arthritis, Rheumatoid Clinical Trial
Official title:
A Multicenter, Randomized, Open Study to Evaluate the Impact of an Electronic Data Capture System on the Care of Patients With Rheumatoid Arthritis
The purpose of this study is to evaluate the utility of an electronic data capture system (EDCS) in a rheumatology clinical practice setting and to assess the impact of this system on patient satisfaction with patient-physician interaction.
Status | Completed |
Enrollment | 1079 |
Est. completion date | July 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients diagnosed with active rheumatoid arthritis according to the revised criteria of the ACR (1987) - Have rheumatoid arthritis that requires regularly scheduled visits with their rheumatologist at least every 3 months - Willing and able to adhere to protocol requirements and participate in a study, lasting 12 months Exclusion Criteria: - Patients currently receiving investigational drugs - Currently participating in other clinical trials or safety registries for rheumatoid arthritis or rheumatoid arthritis -related therapies |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Centocor Ortho Biotech Services, L.L.C. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary endpoints for the Health Tracker-user group are the change in the patient satisfaction and patient-physician interaction surveys between the pre- and post-randomization phases. | |||
Secondary | Changes between the pre- and post-randomization phases in the following clinical evaluations: HAQ scores, SF-12 scores, Patient assessed painful and/or swollen joint counts, Health care professional assessed tender and swollen joint counts |
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