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APART Advanced Profiling of Anti-Rheumatic Therapies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00378261
Recruitment Status : Completed
First Posted : September 19, 2006
Last Update Posted : May 19, 2011
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Procedure: Use of an Electronic Data Capture System by patients and physicians to assess patient-physician interactions & therapeutic decisions & outcomes in RA subjects. Phase 4

Detailed Description:

This is a randomized, multicenter observational study to assess the impact of the EDCS in a rheumatology clinical practice setting on patient satisfaction with patient-physician communication using the Health Tracker electronic data capture system . Patients will be randomly assigned in a 2:1 ratio to the Health Tracker-user or non-user groups, respectively. The primary outcomes of this study will be the impact that information gathered and analyzed by an electronic data capture system has on patient satisfaction with arthritis care and patient physician interactions in clinical practice. Patient satisfaction will be assessed using a questionnaire developed specifically for this study.

This study does not involve the use of any investigational drugs, and the protocol does not mandate the treatment regimen patients will receive. Physicians will prescribe antirheumatic medications in accordance with usual clinical practice. The planned duration of subject participation is 12 months

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1079 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Study Start Date : January 2004
Study Completion Date : July 2005

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378261

Sponsors and Collaborators
Centocor Ortho Biotech Services, L.L.C.
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00378261     History of Changes
Other Study ID Numbers: CR004807
First Posted: September 19, 2006    Key Record Dates
Last Update Posted: May 19, 2011
Last Verified: April 2010

Keywords provided by Centocor Ortho Biotech Services, L.L.C.:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases