N/A
Completed N=125
"Learning About Biologics"-Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01721200 ↗Enrolled (actual)
125
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcomePrimary: The Proportion of Subjects Who Are Classified as Having Made an Informed Value Concordant Choice at 2 Weeks — 32; 13 Percentage of subjects
Summary
This study is a randomized controlled trial designed to examine the efficacy of an educational decision support tool for patients with rheumatoid arthritis who continue to have active disease despite use of traditional disease modifying drugs. The study will take place at Geisinger Medical Center in Danville, PA. Eligible subjects will be identified by the treating physician and those providing consent will be randomized to usual care versus use of the decision support tool.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Subjects Who Are Classified as Having Made an Informed Value Concordant Choice at 2 Weeks |
32; 13 | — |
| SECONDARY Patient-physician Communication |
35.8; 35.6 | — |
| SECONDARY Use of Biologics |
51; 49 | — |
| SECONDARY To Test Screening and Recruitment Procedures |
— | — |
| SECONDARY To Test Uptake |
— | — |
| SECONDARY Acceptability to Physicians |
— | — |
| SECONDARY To Test Adherence to the Intervention |
— | — |
| SECONDARY Changes in Knowledge |
1; 0 | — |
| SECONDARY Changes in Willingness |
— | — |
| SECONDARY Changes in Perceived Knowledge |
-16.7; -8.3 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects must be at least 18 years of age
- Able to speak and read English
- Meet the revised American College of Rheumatology criteria for the diagnosis of RA
- Have active disease warranting initiation of a new biologic (or small molecule if and when FDA-approved) therapy as determined by their rheumatologist
Exclusion Criteria
- Fail to meet the inclusion criteria
- Have a current infection
- Have cancer of any type diagnosed within the past five years (except non-melanoma skin cancer)
- Have a history of lymphoma, leukemia, or melanoma
- Have a chronic inflammatory disease (in addition to rheumatoid arthritis) requiring treatment with immunosuppressive medications
- Have chronic liver disease due to hepatitis C or B
- Are HIV positive
- Have a positive screening test for tuberculosis (tuberculin skin test or interferon-gamma release assay) or radiographic lesions suggestive of inactive tuberculosis and have not completed an adequate course of chemoprophylactic therapy
- Are hearing or visually impaired
- Are scheduled for surgery
Data sourced from ClinicalTrials.gov (NCT01721200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.