Lead Investigator: Joachim Tan, Monash University
Title of Proposal Research: Dose reduction and discontinuation of disease modifying anti-rheumatic drugs (DMARDs) for juvenile idiopathic arthritis
Vivli Data Request: 7427
Funding Source: The researchers performing this research are being funded by Cabrini Health Australia, a not-for-profit health service supporting health related research. The Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology performs high quality clinical research to answer clinically important questions and to promote the translation of clinical evidence into practice and policy change. Our current program of work concerns identifying and reducing low-value health care that arises from over-diagnosis and over-treatment, and identifying ways to improve the sustainability of the health care system. In 2018 we launched the National Health and Medical Research Council (NHMRC) Centre of Research Excellence for the Australia and New Zealand Musculoskeletal (ANZMUSC) Clinical Trial Network. We continue to manage the Australian Rheumatology Association Database and are an editorial base for Cochrane Musculoskeletal and Australasian Satellite of Cochrane Effective Practice and Organisation of Care (EPOC).
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease in childhood, affecting 1 in every 1000 children. It is a chronic condition mediated by the body’s own immune system attacking joints of a young person, causing pain, stiffness, joint swelling, loss of function and loss of mobility.
There are many contemporary pharmacological treatments for JIA include glucocorticoids (systemic and intra-articular), non-steroidal anti-inflammatory drugs (NSAIDs) and disease modifying anti-rheumatic drugs (DMARDS) including conventional synthetic DMARDs (csDMARDs), biologic DMARDs (bDMARDs) and targeted synthetic DMARDs (tsDMARDs). Due largely to these treatments, disease remission is now a realistic target for many patients.
Many patients with JIA are able to achieve clinical remission off medication (Guzman 2015; Tiller 2018; Wallace 2004). For this reason, it is appropriate to consider medication dose reduction or discontinuation for some patients. There is no consensus on the optimal strategy for dose reduction or discontinuation of medications in patients with JIA and clinically inactive disease. This topic has not been addressed in major international guidelines given the paucity of evidence, leading to uncertainty for patients and unnecessary heterogeneity in practice.
This is a protocol for an intervention Cochrane Systematic Review, which will review and collate the data through meta-analysis of the currently available high quality evidence of a specified formulated question. A systematic review utilising Cochrane methodology will specifically extract and analyse data exclusively from randomised controlled trials. The review of existing research will be conducted using a well-established and clearly defined process to ensure accurate evaluation of the studies.
There are no existing Cochrane reviews exploring this topic. A recent systematic review has been undertaken but has not completely adhered to the Cochrane methodology. There are also several upcoming trials that will address this question and the topic could be suitable to adapt as a ‘Living Guideline’.
This will be a systematic review that will be conducted according to the guidelines recommended by the Cochrane Musculoskeletal Group Editorial Board. It will analyse relevant randomised controlled trials and collate results for meta-analysis.
Requested Studies:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis
Data Contributor: AbbVie
Study ID: NCT00048542
Sponsor ID: DE038
A Multicenter, Double-Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Humanized Anti-TNFa Antibody, in Subjects With Active Polyarticular Juvenile Idiopathic Arthritis (JIA) Despite Standard Therapy
Data Contributor: Johnson & Johnson
Study ID: NCT01230827
Sponsor ID: CR017089
A 24 Week Randomized, Double-blind, Placebo-controlled Withdrawal Trial With a 16 Week Open-label lead-in Phase, and 64 Week Open-label Follow-up, to Evaluate the Effect on Clinical Response and the Safety of Tocilizumab in Patients With Active Polyarticular-course Juvenile Idiopathic Arthritis
Data Contributor: Roche
Study ID: NCT00988221
Sponsor ID: WA19977