Validation of advanced treatment for rheumatoid arthritis (tolDC)

Not Applicable

Completed

• Conditions: Rheumatoid arthritis; Musculoskeletal Diseases

• Registration Number: ISRCTN37397692
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-13
• Study Completion: 2022-06-30
• Last Update Posted: 2 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

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

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)

Study & Design

• Study Type: Observational
• Study Design: Not specified