The CORRONA Treat to Target Trial: Outcomes and Feasibility in a US Population
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 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 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: Treat to Target Intervention Strategy
Subjects at sites randomized to this arm will be expected to return to the clinic for Monthly Assessments until low disease activity (LDA) defined as CDAI of 10 or less has been achieved. Providers are prompted to accelerate therapy (Treatment Acceleration) at each visit that CDAI is >10 (unless not felt to be medically appropriate or refused by the subject.) Accelerations are expected at least every 3 months, until/unless LDA has been achieved.
Other: Treatment Acceleration
Other: Monthly Assessment
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)
Monthly disease assessments are expected to be scheduled until the subject has achieved a CDAI of 10 or less (low disease activity).
Other Name: Monthly follow-up visits to rheumatologist
No Intervention: Control Group Treated with Usual Care
Subjects in this arm will be expected to complete study visits with their rheumatologist/study doctor at Baseline, Month 3, Month 6, Month 9 and Month 12. Data collection will occur at each of those visits. Subjects and Providers will continue managing disease per usual practices and do not receive protocol prompts relative to visit frequency or acceleration of therapy, regardless of disease activity level (by CDAI)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01407419
|United States, New York|
|The Center for Rheumatology|
|Albany, New York, United States, 12206|
|Principal Investigator:||Joel Kremer, MD||CORRONA, Inc.|