ISRCTN70160382已完成未知
A pragmatic randomised controlled open trial of the effect of intensive management (IM) compared with standard care (SC) on remission rates at 12 months in rheumatoid arthritis patients with intermediate disease activity
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 335
研究概览
简要总结
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32931984/ results (added 06/10/2020) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37749588/ Secondary analysis (added 26/09/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 11/06/2015:
- •1. Diagnosis of Rheumatoid Arthritis (by ACR, 2010 criteria)
- •2. Have received at least one DMARD for at least six months, and currently receiving at least one DMARD
- •3. Have intermediate disease activity, defined by:
- •3.1. DAS28-ESR 3.2-5.1.
- •3.2. At least three active joints (defined as swollen and/or tender) on 66/68 joint count, to include at least one swollen joint
- •4. Willing and able to follow an intensive management programme
- •5. Able and willing to give informed consent
- •Previous inclusion criteria:
- •1. Diagnosis of Rheumatoid Arthritis (by ACR, 2010 criteria); duration six months to 10 years
- •2. Have received at least one DMARD for at least six months, and currently receiving at least one DMARD
- •3. Have intermediate disease activity, defined by:
- •3.1. DAS28-ESR 3.2-5.1.
- •3.2. At least three swollen joints and three tender joints on 66/68 joint count
- •4. Willing and able to follow an intensive management programme
- •5. Able and willing to give informed consent
排除标准
- •1. Major co-morbidities making intensive treatment inadvisable (e.g. heart failure)
- •2. Previously failed multiple DMARDs (more than or equal to 5 treatments) or having received biologics
- •3. Irreversible disability from extensive joint damage (for example, replacement of three or more major joints)
- •4. Women who are pregnant, breastfeeding or planning to conceive
- •5. Currently in early RA pathway
- •6. Current or recent (within the previous 12 weeks) participation in another interventional trial
研究者
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