This is a 2-part application. PART 1: An abbreviated protocol for a randomized actively controlled trial of early aggressive therapy in poly-JRA. PART II: A plan for development of essential components for the trial's conduct. PART 1: The overall goal of this trial is to improve the physical functional ability and health related quality of life outcomes of children with poly articular juvenile rheumatoid arthritis (poly-JRA).
Specific Aim : To compare the efficacy and safety of an aggressive treatment regimen initiated within the first 6 months of disease in children with poly-JRA to that of the current standard-of-care in producing a state of complete clinical response and improve outcome via a randomized, open trial 6 months in duration. Primary hypotheses are: 1) That aggressive therapy initiated within 6-months of poly-JRA disease onset will result in a higher proportion of children entering a state of complete clinical response as compared to the proportion of children who achieve such a response by use of the current standard-of-care after 6 months of therapy. 2) That early aggressive therapy will result in better physical./functional ability as compared to the current standard-of-care after 6 months of therapy. 3) That early aggressive therapy will result in higher health related quality of life as compared to that produced by the current standard-of-care after 6 months of therapy. PART 2: The overall goal is to develop a written plan for the execution of the clinical trial described in PART 1, and to secure funding for the effort to allow commencement of the trial.
SpecificAim 1 : To determine by questionnaire survey the barriers to the effective participation in trials by the clinical sites involved in this trial as well as other potential sites, including ability to open for patient enrollment in an expeditious manner, recruitment of study participant, follow-up, case report form completion .
Specific Aim 2 : To convene a meeting of senior investigators, methodologists, and regulatory personnel to develop strategies for overcoming the barriers identified in Specific Aim 1.
Specific Aim 3 : To develop criteria for defining one of the primary outcome variables, complete clinical response, and the related term, clinical remission, to be used in the proposed trial.
Specific Aim 4 : To prepare and submit an application to fund the clinical trial described in PART 1.
| Wallace, Carol A; Giannini, Edward H; Spalding, Steven J et al. (2012) Trial of early aggressive therapy in polyarticular juvenile idiopathic arthritis. Arthritis Rheum 64:2012-21 |
| Yi Qian; Jing Pan; Xiaodong Zhou et al. (2010) Contaminated heparin-affected patient plasmas are associated with activated contact systems. Clin Appl Thromb Hemost 16:261-5 |
| Wallace, Carol A; Ruperto, Nicolino; Giannini, Edward et al. (2004) Preliminary criteria for clinical remission for select categories of juvenile idiopathic arthritis. J Rheumatol 31:2290-4 |
