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

NCT01407419 | Completed

• 1 other identifier: NEIRB 11-216
• Study Type: interventional
• Target: 538
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Disease Activity, probability of treatment acceleration conditional on disease activity.

  CDAI Score, rates of acceleration, frequency of visits, time to next visit conditional on disease activity, and probability of acceleration conditional on disease activity.

  1 year

Secondary Outcomes (1)

• Disease activity scores, reasons for ineligibility for treatment acceleration, frequency of toxicity, frequency of TAEs.

  1 year

Study Arms (2)

Treat to Target Intervention Strategy

EXPERIMENTAL

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

Control Group Treated with Usual Care

NO INTERVENTION

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)

Interventions

Treatment Acceleration OTHER

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)

Treat to Target Intervention Strategy

Monthly Assessment OTHER

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

Also known as: Monthly follow-up visits to rheumatologist

Treat to Target Intervention Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• CorEvitas: lead

Study Sites (1)

The Center for Rheumatology

Albany, New York, 12206, United States

Location

Related Publications (1)

• Harrold LR, Reed GW, Harrington JT, Barr CJ, Saunders KC, Gibofsky A, Greenberg JD, John A, Devenport J, Kremer JM. The rheumatoid arthritis treat-to-target trial: a cluster randomized trial within the Corrona rheumatology network. BMC Musculoskelet Disord. 2014 Nov 21;15:389. doi: 10.1186/1471-2474-15-389.

  PMID: 25416400 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Joel Kremer, MD

  CORRONA, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2011
• First Posted: August 2, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 23, 2018

Record last verified: 2015-06

Locations

US (1)