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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
The Consortium of Rheumatology Researchers of North America, Inc.
ClinicalTrials.gov Identifier:
NCT01407419
First received: July 29, 2011
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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 Intervention
Rheumatoid Arthritis
Other: Treatment Acceleration
Other: Monthly Assessment

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by The Consortium of Rheumatology Researchers of North America, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 530
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)
Arms Assigned Interventions
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407419

Locations
United States, New York
The Center for Rheumatology
Albany, New York, United States, 12206
Sponsors and Collaborators
The Consortium of Rheumatology Researchers of North America, Inc.
Investigators
Principal Investigator: Joel Kremer, MD CORRONA, Inc.
  More Information

No publications provided

Responsible Party: The Consortium of Rheumatology Researchers of North America, Inc.
ClinicalTrials.gov Identifier: NCT01407419     History of Changes
Other Study ID Numbers: NEIRB 11-216
Study First Received: July 29, 2011
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Consortium of Rheumatology Researchers of North America, Inc.:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014