The CORRONA Treat to Target Trial
The CORRONA Data Collection Program is a voluntary registry which collects physician and patient level data on care and outcomes of enrolled RA patients The Treat to Target Trial is a sub-study of the CORRONA Data Collection Program. New and existing CORRONA sites and patients may be recruited to participate as subjects in this 12 month trial examining outcomes and feasibility of implementing a Treat to Target approach, when compared with a control group of subjects treated with usual care.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treating to Target (T2T) for Patients With Rheumatoid Arthritis in a US Population: Outcomes and Feasibility|
- Disease Activity, probability of treatment acceleration conditional on disease activity. [ Time Frame: 1 year ] [ Designated as safety issue: No ]CDAI Score, rates of acceleration, frequency of visits, time to next visit conditional on disease activity, and probability of acceleration conditional on disease activity.
- Disease activity scores, reasons for ineligibility for treatment acceleration, frequency of toxicity, frequency of TAEs. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]CDAI scores, DAS 28, RAPID 3, reasons/frequency of ineligibility for treatment acceleration, frequency of suspected (RA) drug-related toxicity, frequency of TAEs
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
|Experimental: Treat to Target Intervention Strategy||
Other: Treatment Acceleration
Subjects in the intervention group will be seen as frequently as monthly for subjects not achieving low disease activity (LDA) as defined as CDAI ≤10. Treatment acceleration will be expected to occur as frequently as monthly and at least every 3 months in these subjects, unless contraindicated.
Treatment acceleration for the purposes of this trial include the following options: Change in prescribed treatment or dosage of "traditional" or "biologic" Disease Modifying Anti Rheumatic Drugs (DMARDs) or a change in the route of Methotrexate administration (from oral to subcutaneous)
|No Intervention: Control Group Treated with Usual Care|
Show Detailed Description
|United States, New York|
|The Center for Rheumatology|
|Albany, New York, United States, 12206|
|Principal Investigator:||Joel Kremer, MD||Center for Rheumatology, Albany, NY|