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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01407419
Recruitment Status : Completed
First Posted : August 2, 2011
Last Update Posted : August 23, 2018
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Other: Treatment Acceleration Other: Monthly Assessment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 538 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treating to Target (T2T) for Patients With Rheumatoid Arthritis in a US Population: Outcomes and Feasibility
Study Start Date : July 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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).
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)

Primary Outcome Measures :
  1. Disease Activity, probability of treatment acceleration conditional on disease activity. [ Time Frame: 1 year ]
    CDAI Score, rates of acceleration, frequency of visits, time to next visit conditional on disease activity, and probability of acceleration conditional on disease activity.

Secondary Outcome Measures :
  1. Disease activity scores, reasons for ineligibility for treatment acceleration, frequency of toxicity, frequency of TAEs. [ Time Frame: 1 year ]
    CDAI scores, DAS 28, RAPID 3, reasons/frequency of ineligibility for treatment acceleration, frequency of suspected (RA) drug-related toxicity, frequency of TAEs

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  1. Patients under the age of 18
  2. Women who are pregnant, breastfeeding or planning to become pregnant during the study period.
  3. 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.
  4. Functional class IV as defined by the ACR classification of functional status
  5. Patients receiving a daily dose of prednisone of >10 mg within the 4 weeks prior to enrollment.
  6. History of positive tuberculin skin test or equivalents that have not received documented treatment for latent tuberculosis (TB).
  7. Patients with a significant, uncontrolled concomitant illness such as, but not limited to cardiovascular, renal, neurological, endocrinological, gastrointestinal, hepatic, metabolic, pulmonary or lymphatic disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01407419

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United States, New York
The Center for Rheumatology
Albany, New York, United States, 12206
Sponsors and Collaborators
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Principal Investigator: Joel Kremer, MD CORRONA, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: CorEvitas Identifier: NCT01407419    
Other Study ID Numbers: NEIRB 11-216
First Posted: August 2, 2011    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: June 2015
Keywords provided by CorEvitas:
Rheumatoid Arthritis
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases