MedTrace Logo

The CORRONA Treat to Target Trial: Outcomes and Feasibility in a US Population

NCT01407419 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 538

Last updated 2018-08-23

No results posted yet for this study

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 feasibility of implementing a Treat to Target approach, when compared with a control group of subjects treated with usual care.

Conditions

Interventions

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)

OTHER

Monthly Assessment

Monthly disease assessments are expected to be scheduled until the subject has achieved a CDAI of 10 or less (low disease activity).

Sponsors & Collaborators

  • CorEvitas

    lead NETWORK

Principal Investigators

  • Joel Kremer, MD · CORRONA, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01407419 on ClinicalTrials.gov