RESEARCH COMMITTEES: JIA
General JIA: This Workgroup is currently focused on the evaluation and management of inactive disease. A project to assess the factors most important to physicians and families in the decision to discontinue medications due to inactive disease has begun and grant funds are being sought to expand the project. The next major step will be to apply the findings to real-world observational data and possibly design an interventional study around medication discontinuation. The STOP-JIA Study is the evaluation of the CARRA Poly-JIA CTPs and was recently funded by a research grant from PCORI. Patient enrollment began in November 2015, and data are being collected in the CARRA Registry.
Outcomes: There are multiple ongoing projects associated with the Outcomes Workgroup. There is an ongoing effort to re-examine the JIA Core Set Variables from the patient/caregiver perspective and this project has been endorsed by OMERACT. Work continues to better standardize the scoring of the MD global assessment of disease activity and parent global assessment of overall well-being.
Spondyloarthritis: This Workgroup is considering further study of the definition and natural history of sacroiliitis in childhood, as well as possible development of CARRA CTPs for the treatment of enthesitis-related arthritis.
Systemic JIA: The Workgroup is beginning to examine the incidence of cardiopulmonary disease in SJIA and appropriate screening practices for these disease manifestations. The Workgroup also aims to assess factors surrounding the management of inactive disease.
Ultrasound: The Workgroup is planning a hands-on standardization exercise on the entheses during the CARRA 2016 Annual Meeting for anyone interested in participating in multi-center research studies. They will also be performing a synovitis scoring exercise on pre-generated images. Input from any level of ultrasound experience is welcomed. The Workgroup is also planning to produce 2 hands-on, 4-hour ultrasound courses immediately preceding the 2016 CARRA Meeting in Toronto; one introductory course for novices and one intermediate/advanced course. More detailed information on the courses will be provided later with CARRA Annual Meeting registration materials.
Uveitis: The Uveitis Workgroup has completed the CARRA CTPs for the management of uveitis that requires systemic therapy and for the management of uveitis that is refractory to methotrexate. They will be seeking approval from the CARRA Membership in the immediate future.
Principal Investigators: Mark Connelly, PhD, Children’s Mercy Hospital and Jennifer Stinson, RN, PhD, University of Toronto and The Hospital for Sick Children
The major goal of this project is to evaluate through a randomized controlled trial the efficacy of an internet-based disease self-management program for English- and Spanish-speaking adolescents with JIA in 9 pediatric rheumatology centers in the CARRA network.
The objective of this grant project is to conduct a definitive test of an investigator-developed online coping skills training program for English- and Spanish-speaking adolescents with JIA. Based on data from the investigators’ preliminary work, the central hypothesis is that use of an online coping skills training program will produce superior improvements in pain and health-related quality of life outcomes for adolescents with JIA relative to outcomes attained with reviewing extant online educational information about JIA and receiving additional attention to coping efforts (control condition). Specific aims for the proposed work include (a) determining the extent to which an online coping skills training program for adolescents with JIA produces improvements in key health outcomes that currently do not optimally respond to only contemporary medical management (pain and health-related quality of life); and (b) determining predictors of change in pain and health-related quality of life indices in adolescents with JIA. An exploratory aim is to determine the acceptability and preliminary efficacy of online coping skills training within a subgroup of Hispanic adolescents with JIA. These aims will be achieved through the approach of using a multicenter randomized controlled trial in which a sample of 360 consenting English- and Spanish-speaking adolescents aged 12-18 years with JIA will be enrolled and randomized into one of two groups: (a) an experimental group consisting of a 12-week interactive online multicomponent treatment protocol including targeted disease education, training in empirically supported cognitive-behavioral coping skills, and social support augmented by monthly telephone contact with a nurse; or (b) a control group consisting of 12 weeks of guided access to extant online resources for disease education and additional attention to own best efforts at managing JIA via monthly telephone contact with a nurse. Outcome data will be collected from both groups prior to treatment, immediately following the intervention, and at 6- and 12-month follow-up assessments. Successful completion of this project is expected to establish to what extent and how an innovative online self-management program produces change in clinically relevant health outcomes in both English- and Spanish-speaking adolescents with JIA.
Principal Investigator: Robert Colbert, MD, PhD, National Institutes of Health
The National Institute of Arthritis and Musculoskeletal and Skin Diseases is conducting a study to learn more about the early signs and symptoms of spondyloarthritis (SpA). The goal of this study is to follow the activity and progression of SpA. Patients will be screened with a comprehensive individual history and a physical examination that includes a detailed musculoskeletal exam. Participants of any age with a diagnosis of SpA may be eligible. This protocol will serve as a screening protocol for a future SpA treatment protocol.
For more information call 1-866-444-2214, TTY1-866-411-1010, or visit clinicaltrials.gov.
Principal Investigator: Beth Gottlieb, MD, MS, Schneider Children’s Hospital, New Hyde Park, NY
This is a prospective multicenter observational study. Currently, 23 centers in the United States and Canada participate in this study. This study follows a cohort of JRA patients collected from 1996-99 in a study conducted by Dr. Suzanne Bowyer in Indiana and a new cohort of JRA patients currently being enrolled and followed. Enrollment into the new cohort began in July 2001 when funding was granted through the Arthritis Foundation.
- To continue to follow the cohort of 473 children with JRA already assembled from pediatric rheumatology centers across the United States as a result of previous arthritis foundation funding provided to this group. These patients have been entered into a large database and are being followed at one-year intervals in order to record their disease progression, medication use, laboratory and radiographic parameters and functional status.
- To enter approximately 500 newly diagnosed JRA patients from the same pediatric rheumatology centers into a second database over a 4 year period in order to describe disease activity, medication use, laboratory and radiographic parameters and functional status at diagnosis and at 1 year intervals. This cohort will expand on the original cohort (see number 1 above) by including children diagnosed in an era of new treatments – the biologic response modifiers – which are likely to change the long-term outcome in children with JRA.
- To attempt to identify clinical, serological or treatment markers that predict, a mild or aggressive course, early in the disease process.
- To describe the current patterns of use of methotrexate and newer biologic response modifiers in children with JRA in a practice setting and to compare the functional outcome of children treated with these medications to that of children not taking them.
- To prospectively study the occurrence of medication side effects in this population.
Patients are considered for inclusion into the study if they are diagnosed with JRA according to ACR criteria and have not been treated with appropriate medications for 6 weeks or longer. Baseline data collected includes: date of onset of arthritis, subtype of arthritis, joint counts, extra-articular manifestations, lab and x-ray results (when performed), and a parent’s functional assessment (the CHAQ) and pain assessment. Data is then collected on a yearly basis. Yearly data collection includes: subtype of arthritis, joint counts, requirement for PT/OT, social work intervention, splints or other assistive devices, extra-articular manifestations, lab and x-ray results (when performed), medications used in the past year and any associated side effects, and a parent’s functional assessment (the CHAQ) and pain assessment.
This study will represent the largest cohorts of patients with JRA ever assembled in North America for a clinical study and will provide reliable information about the functional outcome of children with JRA who were diagnosed and treated in the 1990’s and beyond. This study will systematically assess the outcome of JRA patients treated both before and after the introduction of the new biologic response modifiers. The study will emphasize functional ability and will allow a comparison of the outcome of patients treated before and after the introduction of these treatment options. It will serve as a valuable resource for the pediatric rheumatology community, will generate hypotheses for future study and could potentially be continued to give long-term (15-20 years) outcome results on these two cohorts of patients as well.
Principal Investigators: Egla Rabinovich, MD, MPH, Duke University Medical Center and Deborah Levy, MD, Children’s Hospital of New York – Presbyterian
- To examine the efficacy of infliximab for the treatment of persistent uveitis in children, utilizing a prospective multi-center registry.
- To develop consensus for the administration schema of infliximab for the treatment of chronic uveitis in children through a consensus conference. We will aim for an agreed methotrexate dose and two different initial doses of infliximab. Twelve interested pediatric rheumatology centers will be chosen from current members of Childhood Arthritis and Rheumatology Research Alliance (CARRA) to participate in this registry.
- Using the agreed upon standardized methods, to administer infliximab for the treatment of chronic uveitis in children, while prospectively examining standardized ophthalmologic outcomes.
- To apply for funding from Centocor and the Arthritis Foundation to extend the registry to 18 months.
- To compare the efficacy between two doses of infliximab for the treatment of persistent childhood uveitis.
- To collect prospective multi-center data on the side effects of infliximab administration when used for the treatment of chronic uveitis in children.
Safety and effectiveness of rilonacept for treating systemic juvenile idiopathic arthritis in children and young adults
Principal Investigator: Norman T. Ilowite, MD, Montefiore Medical Center
Principal Investigator: Betsy Mellins, MD, Stanford University Medical Center, Palo Alto, CA
Principal Investigator: Carol Wallace, MD, Seattle Children’s Hospital
Principal Investigator: Daniel Lovell, MD, MPH, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH
Principal Investigator: Sampath Prahalad, MD, MSc, Emory University, Atlanta, GA
Validation of a self-report and proxy-report questionnaire about complementary and alternative medicine for children and adolescents with juvenile idiopathic arthritis
Principal Investigator: Jennifer Stinson, RN, PhD, The Hospital for Sick Children, Toronto, ON, Canada
Investigators: Dr. Jennifer Stinson (PI), Dr. Karine Toupin-April, Dr. David Moher, Dr. Heather Boon, Dr. Peter Tugwell, Dr. Ciaran Duffy
Collaborators: Dr. Lynn Spiegel, Dr. Martin Descarreaux, Dr. Sunita Vohra
Juvenile Idiopathic Arthritis (JIA) is one of the most common childhood chronic illnesses and can negatively impact all aspects of quality of life. Parents may seek complementary and alternative medicine (CAM), especially if they are not satisfied with conventional care. Studies have shown that CAM use is common in children with JIA, making it important to evaluate families’ perceptions of CAM in research and clinical practice. While families of a child with JIA and their health care providers should discuss CAM, there is no standardized manner of evaluating its use and questionnaires assessing CAM use have not been thoroughly validated.
To address this gap, our research group will develop and validate a questionnaire assessing CAM use which could be completed by children with JIA as well as their parents. This questionnaire will enable health care practitioners and researchers to evaluate clinically relevant behaviors and perceptions of families concerning CAM.
This new CAM questionnaire is being developed in a sequential phased approach. In Phase 1, a systematic review (SR) of measurement properties of CAM questionnaires has been conducted. Results showed that none of the 96 identified questionnaires showed appropriate measurement properties. In Phase 2, a Delphi survey and a consensus conference were used to develop consensus amongst key stakeholders in pediatrics, rheumatology and CAM on the child self-report and parent proxy-report questionnaires. Domains and items to be included in the CAM questionnaire were identified and the research team drafted the child and parent versions of the questionnaire. In Phase 3, the face and content validity of both versions will be assessed by ten pediatric rheumatology health care professionals and ten JIA patients and their parents/caregivers. In Phase 4, a descriptive study will determine the reliability as well as construct and criterion validity of the new questionnaires in a sample of 85 JIA patients and their parents/caregivers as well as 43 CAM providers consulted by recruited families. Construct validity will verify if responses to the new questionnaire are strongly associated with other constructs which should be related to CAM use according to the scientific literature (e.g. parental CAM use, children’s disease severity and health-related quality of life). Criterion validity will ensure that the CAM questionnaire is correlated with a gold standard, which is the opinion of patients’ CAM providers for participants who received treatments in the presence of their provider (e.g. massage, acupuncture and chiropractic). For participants who used treatments prescribed by a CAM provider but that were not followed in their presence (e.g. dietary and herbal supplements), participants will be asked to complete a daily diary which will record use and perceptions of CAM for a period of two weeks. At the end of the two weeks, children and their parents/caregivers will be asked to complete the CAM questionnaire either at the hospital or at their home (and mailed back to the research centre) in order to establish its test-retest reliability.
Principal Investigators: Carol Wallace, MD, University of Washington; Daniel Lovell, MD, MPH and Edward Gianinni, MScDrPH, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH