The rheumatoid arthritis treat-to-target trial: a cluster randomized trial within the Corrona rheumatology networkReport as inadecuate




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BMC Musculoskeletal Disorders

, 15:389

Clinical rheumatology and osteoporosis

Abstract

BackgroundThe treat-to-target T2T approach to the care of patients with rheumatoid arthritis involves using validated metrics to measure disease activity, frequent follow-up visits for patients with moderate to high disease activity, and escalation of therapy when patients have inadequate therapeutic response as assessed by standard disease activity scores.
The study described is a newly launched cluster-randomized behavioral intervention to assess the feasibility and effectiveness of the T2T approach in US rheumatology practices.
It is designed to identify patient and provider barriers to implementing T2T management.
This initial paper focuses on the novel study design and methods created to provide these insights.

Methods-DesignThis trial cluster-randomizes rheumatology practices from the existing Corrona network of private and academic sites rather than patients within sites or individual investigators to provide either T2T or usual care UC for qualified patients who meet the 2010 revised American College of Rheumatology criteria for the diagnosis of rheumatoid arthritis and have moderate to high disease activity.
Specific medication choices are left to the investigator and patient, rather than being specified in the protocol.
Enrollment is expected to be completed by the end of 2013, with 30 practices randomized and enrolling a minimum of 530 patients.
During the 12-month follow-up, visits are mandated as frequently as monthly in patients with active disease in the T2T group and every 3 months for the UC group.
Safety data are collected at each visit.
The coprimary endpoints include a comparison of the proportion of patients achieving low disease activity in the T2T and UC groups and assessment of the feasibility of implementing T2T in rheumatology practices, specifically assessment of the rates of treatment acceleration, frequency of visits, time to next visit conditional on disease activity, and probability of acceleration conditional on disease activity in the 2 groups.

DiscussionThis cluster-randomized behavioral intervention study will provide valuable insights on the outcomes and feasibility of employing a T2T treatment approach in clinical practice in the United States.

Trial registrationNCT01407419

KeywordsTreat to target Rheumatoid arthritis Corrona Usual care AbbreviationsACRAmerican College of Rheumatology

BeStBehandel Strategieen study

CDAIClinical Disease Activity Index

DAS28Disease activity score of 28 joints

DMARDDisease-modifying antirheumatic drug

ESRErythrocyte sedimentation rate

EULAREuropean league Against Rheumatism

GCPGood Clinical Practice

ICCIntraclass correlation

IRBInstitutional review board

LDALow disease activity

RARheumatoid arthritis

RAPID3Routine Assessment of Patient Index Data 3

T2TTreat to target

TICORATight Control of Rheumatoid Arthritis

UCUsual care.

Electronic supplementary materialThe online version of this article doi:10.1186-1471-2474-15-389 contains supplementary material, which is available to authorized users.

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Author: Leslie R Harrold - George W Reed - J Timothy Harrington - Christine J Barr - Katherine C Saunders - Allan Gibofsky - Je

Source: https://link.springer.com/



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