Rheumatoid arthritis Musculoskeletal Diseases Rheumatoid arthritis
Conditions
Interventions
Leukocytes will be collected from Anti-citrullinated protein antibody (ACPA) positive Rheumatoid Arthritis (RA) patients and used for the GMP process and product validation of an advanced therapy medi
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. ACPA positive RA based on local NHS laboratory cut-off. If ACPA titre is 3.2
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of patients who successfully complete the leukaphereis procedure, where success is determined by the collection of a leukocyte sample of 100mls at a single time point | — |
Secondary
| Measure | Time frame |
|---|---|
| Properties of the final product measured at a single time point: 1. Cell number measured using Flow cytometry 2. Viability measured using Flow Cytometry/Trypan Blue Exclusion Assay (TBC) 3. Yield (number compared to cells at the start of the process) measured using Flow Cytometry 4. Purity (number of TolDC cells compared to non-TolDC cells) measured using Flow Cytometry 5. Potency (ability of cells to function as intended) measured using Functional assay measuring IFNy in co-culture | — |
Countries
England, United Kingdom
Contacts
Public ContactMiranda Morton
Outcome results
None listed