ISRCTN14999554进行中（未招募）2 期
A single-centre, experimental medicine study investigating the route of delivery and potential efficacy of autologous tolerogenic dendritic cell (tolDC) therapy for rheumatoid arthritis
ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 20 人开始时间: 2023年9月27日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adults aged 18 years old or over
- •2. Rheumatoid Arthritis fulfilling 1987 ARA criteria or 2010 ACR/EULAR Classification Criteria
- •3. ACPA positive (>3x upper limit of normal)
- •4. Able and willing to give informed consent and comply with the study protocol
- •5. Disease duration at least 4 months and less than ten years
- •6. ACR Functional Class I-III
- •7. DAS 28 <5.1
- •8. If receiving disease-modifying anti-rheumatic drugs (DMARD) these can be at any dose or combination of methotrexate, sulphasalazine, azathioprine, hydroxychloroquine, abatacept, rituximab (last dose >6 months ago), TNF-alpha inhibitors and IL6 receptor antagonists but must have been stable for 4 weeks.
- •9. Stable dose of non-steroidal anti-inflammatory drugs (NSAID) for at least 4 weeks prior to screening (only applicable for patients taking NSAID as part of their standard care)
- •10. Possess at least one copy of a shared epitope HLA DRB1 allele (0101; 0102; 0105; 0401; 0404; 0405; 0408; 0409; 0410; 0413; 0416; 0419; 0421; 1001; 1402; 1406; 1409; 1413; 1417; 1419; 1420; 1421)
排除标准
- •1. Use of other investigational medicinal products within 30 days prior to study entry (defined as date of consent into study)
- •2. Any Rheumatoid Arthritis treatment or dose changes within 4 weeks of study entry.
- •3. Current treatment with Janus kinase inhibitors or leflunomide. Previous treatment is permitted provided at least 12 weeks have elapsed since discontinuation of the therapy and study entry
- •4. Receiving glucocorticoids by any route within 4 weeks of study entry, apart from topical, intra-nasal or inhaled
- •5. Serious or unstable co-morbidity that prohibits participation in the study at the discretion of the investigator, eg. Significant COPD, significant cardiac failure, active malignancy
- •6. Active infection at study entry (except fungal nail infection)
- •7. Infection requiring hospitalisation, or IV antibiotics, within 4 weeks prior to study entry
- •8. Immunisation with live, attenuated vaccines planned within 14 days of baseline visit (administration of TolDCcitpep) and with non-live vaccines planned within 7 days of baseline visit
- •9. History of hepatitis B or C, HIV, or HTLV-1/2 infection(s)
- •10. Recent history of CMV infection (positive for CMV IgM antibodies) or syphilis infection (positive PCR test)
- •11. Major surgery within 8 weeks prior to study entry or planned within 12 weeks of baseline visit.
- •12. Pregnancy, or women planning to become pregnant within the study period, or women who are breast feeding
- •13. Females of child bearing potential engaging in heterosexual relationships unwilling to use adequate contraception for duration of study
- •14. Patients taking anticoagulants that cannot be interrupted and are, in the judgement of the investigator, likely to interfere with study procedures
- •15. Known hypersensitivity to local anaesthetic
- •16. Poor venous access or medical condition precluding leukapheresis e.g. unstable cardiac arrythmia (atrial fibrillation permitted)
- •17. Hb<10g/dL; neutrophils< 1.00 x10^9/L; platelets <100x10^9/
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