Collection of white blood cells [using leukapheresis] from rheumatoid arthritis patients for the validation of an advanced treatment for rheumatoid arthritis (tolDC)

ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 6 人开始时间: 2021年4月13日最近更新: 2023年8月2日

适应症

试验速览

暂无简介。

•1. ACPA positive RA based on local NHS laboratory cut-off. If ACPA titre is <3 times laboratory upper limit of normal, patients must also be RF positive based on local NHS laboratory cut-off
•2. Age 18 years or over
•3. Ability to provide written informed consent
•4. Receiving methotrexate, either as monotherapy or in combination with additional conventional synthetic disease modifying drug(s) (csDMARDs) at a stable dose for at least 4 weeks prior to screening
•5. At least 6 months since diagnosis of RA
•6. ACR Functional Class I-III
•7. Active disease – DAS 28 >3.2

•1. Use of investigational medicinal products within 30 days prior to screening date
•2. Receiving biologic DMARD or targeted synthetic DMARD (tsDMARD)
•3. Receiving glucocorticoids by any route accept topical/inhaled within 4 weeks of screening (nasal spray permitted)
•4. Receiving non-steroidal anti-inflammatory drugs (NSAID) at an unstable dose. Patients may be receiving NSAID prior to screening, provided the dose has been stable for at least 4 weeks prior to screening.
•5. Serious or unstable co-morbidity deemed unsuitable by PI, eg. COPD, cardiac failure
•6. Any known medical condition or contra-indication to leukapheresis, e.g. positive serology screen for hepatitis B or C, HIV infections
•7. History of hepatitis B or C, syphilis, HIV, CMV or HTLV-1/2 infections
•8. History of recurrent or chronic infection
•9. Pregnancy, or women planning to become pregnant within the study period, or women who are breast feeding
•10. Known hypersensitivity to local or systemic corticosteroid therapy or local anaesthetic
•11. Poor venous access or medical condition precluding leukapheresis
•12. Infection requiring hospitalization or IV antibiotics within 6 weeks of leukapheresis procedure
•13. Immunization with live vaccine within 6 weeks of leukapheresis procedure
•14. Anaemia defined as Hb<10g/dL; neutrophils< 2.00 x109/L; platelets <150x109/L
•15. Known active infection at screening visit or at screening (except fungal nail infection)

发起方

ewcastle upon Tyne Hospitals NHS Foundation Trust