APART Advanced Profiling of Anti-Rheumatic Therapies

This study has been completed.
Sponsor:
Information provided by:
Centocor Ortho Biotech Services, L.L.C.
ClinicalTrials.gov Identifier:
NCT00378261
First received: September 15, 2006
Last updated: May 18, 2011
Last verified: April 2010

September 15, 2006
May 18, 2011
January 2004
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00378261 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
APART Advanced Profiling of Anti-Rheumatic Therapies
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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1079
July 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00378261
CR004807
Not Provided
Not Provided
Centocor Ortho Biotech Services, L.L.C.
Not Provided
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
Centocor Ortho Biotech Services, L.L.C.
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP