Status:
COMPLETED
The CORRONA Treat to Target Trial: Outcomes and Feasibility in a US Population
Lead Sponsor:
CorEvitas
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The Treat to Target Trial is a clinical trial available to new and existing CORRONA (Data Collection Program) sites. Subjects are recruited to participate in this 12 month trial examining outcomes and...
Detailed Description
New and existing CORRONA sites and patient participants are recruited to participate as subjects in this 12 month trial examining outcomes and feasibility of implementing a Treat to Target approach to...
Eligibility Criteria
Inclusion
- Patients eligible for the study will be both male and female adult (at least 18 years of age) patients who have a documented diagnosis of RA, are enrolled or willing to be enrolled in the CORRONA registry for the duration of the trial, have signed appropriate informed consent documents, are willing to participate in the trial, are medically appropriate for participation in the opinion of the investigator, and have moderate to severe RA disease activity as defined by CDAI \>10.
Exclusion
- Patients under the age of 18
- Women who are pregnant, breastfeeding or planning to become pregnant during the study period.
- Patients with chronic or acute pain condition(s) other than active RA which, in the opinion of the investigator, is likely to confound or interfere with assessments of RA disease activity.
- Functional class IV as defined by the ACR classification of functional status
- Patients receiving a daily dose of prednisone of \>10 mg within the 4 weeks prior to enrollment.
- History of positive tuberculin skin test or equivalents that have not received documented treatment for latent tuberculosis (TB).
- Patients with a significant, uncontrolled concomitant illness such as, but not limited to cardiovascular, renal, neurological, endocrinological, gastrointestinal, hepatic, metabolic, pulmonary or lymphatic disease.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
538 Patients enrolled
Trial Details
Trial ID
NCT01407419
Start Date
July 1 2011
End Date
July 1 2014
Last Update
August 23 2018
Active Locations (1)
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1
The Center for Rheumatology
Albany, New York, United States, 12206