Start Time Optimization of Biologics in Polyarticular JIA
关键词
抽象
描述
STOP-JIA is a prospective, observational study comparing the clinical effectiveness and impact on patient reported outcomes of 3 different treatment strategies (CTPs) in new onset pJIA patients to answer the critical question of when to start biologic medications. All participants will be enrolled in the CARRA Registry and started on one of the CTPs, which will be decided by the treating physician and patient/caregiver. Subjects will be enrolled at one of 60 participating CARRA sites across the US and Canada. Total anticipated enrollment is >400, or 200 patients per year over 2 years of recruitment.
Specific Aim 1:
To compare the clinical effectiveness of different strategies (CTPs) for using biologic medications in achieving clinically inactive disease (CID) at 12 months in new-onset pJIA. Three common strategies that differ in the timing of biologic medication introduction will be compared: 1) Step-Up: disease modifying anti-rheumatic drug (DMARD) monotherapy stepping up by addition of a biologic medication if needed; 2) Early Combination: DMARD plus biologic medication at treatment onset; and 3) Biologic First: biologic medication monotherapy at treatment onset.
Hypothesis 1: A significantly higher proportion of children started on a biologic medication at onset (CTP 2 or 3) will achieve CID after 12 months of therapy compared to standard therapy (CTP 1).
Specific Aim 2:
To compare patient and caregiver reported outcomes between the different strategies.
Hypothesis 2: There will be statistically significant differences in patient/caregiver reported outcomes (PROs) between treatment strategies that can inform future patients and providers in selecting optimal treatments.
The CARRA Registry will be housed at CARRA's clinical and data coordinating center, Duke Clinical Research Institute (DCRI). The CARRA Registry Protocol documents that the CARRA Registry fulfills all PCOR standards for registries. STOP-JIA will utilize data collection, storage, and management processes, systems requirements, and security processes already established for the CARRA Registry at DCRI.
STOP-JIA will use Web-based electronic CRFs (eCRFs) developed for the CARRA Registry that are already familiar to site personnel. The eCRF platform, RAVE, is 21CFR part11 compliant and meets regulatory requirements. Database and Web servers are secured by a firewall and through controlled physical access. eCRFs will be monitored for completeness, accuracy, and attention to detail throughout the study by DCRI data and site management teams using processes developed for the CARRA Registry and consistent with DCRI's internal SOPs. Use of electronic data capture will allow for immediate prompts/queries if entered values are out of expected ranges or there are incomplete data fields. The design of the data collection instrument will allow centers to record a planned assessment of a patient was missed and to enter any known reasons for the assessment being missed. DCRI will regularly provide reports detailing data completion metrics to the sites. Stakeholder engagement is also an important aspect of this study, and patients/caregivers as well as other stakeholders are serving as research partners and advisors in this study.
日期
| 最后验证: | 09/30/2019 |
| 首次提交: | 10/28/2015 |
| 提交的预估入学人数: | 10/28/2015 |
| 首次发布: | 10/29/2015 |
| 上次提交的更新: | 10/01/2019 |
| 最近更新发布: | 10/02/2019 |
| 实际学习开始日期: | 10/31/2015 |
| 预计主要完成日期: | 09/29/2019 |
| 预计完成日期: | 09/29/2019 |
状况或疾病
相
资格标准
| 有资格学习的年龄 | 2 Years 至 2 Years |
| 有资格学习的性别 | All |
| 取样方式 | Non-Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Age less than 19 at baseline (if 18 or older, agrees to be followed for at least one year) - Diagnosis of Arthritis per ACR definition. - Arthritis present in one joint for a least six weeks - At least 5 active joints at baseline - Contraception if sexually active (male and female) May have any of the following: - RF+ polyarticular JIA - RF- polyarticular JIA - Extended oligoarticular JIA - Psoriatic JIA - Enthesitis related JIA - Undifferentiated JIA - Psoriasis - Sacroiliitis - Uveitis - Enthesitis - Prior treatments permitted: - NSAIDS - Hydroxychloroquine - Intraocular / topical / intraarticular glucocorticoids - IV or PO steroids if one of the below criteria are met: --If treated ≤ 3 months prior to baseline: treatment cannot exceed 2 weeks --If treated > 3 months prior to baseline: any treatment course is permitted as long as treatment was completed 90 days prior to baseline - Methotrexate started no more than 1 month prior to the baseline visit - Biologics — received only 1 dose within 1 week of the baseline visit Exclusion Criteria: - Features consistent with systemic JIA - Treatment with any medications for JIA aside from those listed above. - Known inflammatory bowel disease - Known celiac disease - Known Trisomy 21 - History of or current malignancy - Concomitant serious active or recurrent chronic bacterial, fungal or viral infection - Significant organ system disorder limiting use of treatments for pJIA - Live vaccine within a month prior to baseline |
结果
主要结果指标
1. Clinical inactive disease (CID) [12 months]
次要成果指标
1. Patient and caregiver reported outcomes [12 months]
