ISRCTN87426082Completed未知
Autologous TOlerogenic Dendritic Cells for Rheumatoid and Inflammatory Arthritis: a randomised controlled trial
ewcastle Hospitals Foundation NHS Trust (UK)0 sites12 target enrollmentStarted: April 27, 2012Last updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 12
Study Overview
Brief Summary
- 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/27117700 (added 21/01/2019)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Current inclusion criteria as of 10/04/2014:
- •1. Participants will be patients with rheumatoid arthritis according to the 1987 or 2010 American College of Rheumatology (ACR) classification criteria or inflammatory arthritis
- •2. Able and willing to give informed consent and to comply with the study protocol
- •3. At least 6 months duration
- •4. ACR Functional Class I-III (for RA patients)
- •5. Age 18 years or over
- •6. Active disease, including an inflamed (native) knee joint
- •7. Failure (or intolerance of) at least one disease modifying anti-rheumatic drug (DMARD), including current therapy
- •8. Morning stiffness in the target joint greater than or equal to 30 minutes
- •9. Willing and able to undergo arthroscopic procedures under local anaesthetic
- •10. Stable dose of non-steroidal anti-inflammatory drug (NSAID) or corticosteroid (prednisolone10mg) for >/=4 weeks
- •11. No intramuscular glucocorticoid administration for 6 weeks
- •12. Stable dose of disease-modifying anti-rheumatic drug (DMARD) for >/= 8 weeks
- •13. Target Gender: Male & Female
- •Previous inclusion criteria:
- •1. Participants will be patients with rheumatoid arthritis according to the 1987 or 2010 American College of Rheumatology (ACR) classification criteria
- •2. Able and willing to give informed consent and to comply with the study protocol
- •3. At least 6 months duration
- •4. ACR Functional Class I-III
- •5. Age 18 years or over
- •6. Active disease, including an inflamed (native) knee joint
- •7. Failure (or intolerance of) at least one disease modifying anti-rheumatic drug (DMARD), including current therapy
- •8. Morning stiffness in the target joint 30 minutes
- •9. Willing and able to undergo arthroscopic procedures under local anaesthetic
- •10. Stable dose of non-steroidal anti-inflammatory drug (NSAID) or corticosteroid (prednisolone¡10mg) for >/=4 weeks
- •11. No intramuscular glucocorticoid administration for 6 weeks
- •12. Stable dose of disease-modifying anti-rheumatic drug (DMARD) for >/= 8 weeks weeks
- •13. Target Gender: Male & Female
Exclusion Criteria
- •1. Use of other investigational medicinal products within 30 days prior to study entry (defined as date of recruitment into study)
- •2. Patients who have received rituximab therapy and whose B-cell count remains below the normal range. Patients who have received any other cell depleting therapies and whose cell counts have not returned to the normal range, at the discretion of the principal investigator (PI).
- •3. Serious or unstable co-morbidity deemed unsuitable by PI, eg. Chronic obstructive pulmonary disease (COPD), cardiac failure
- •4. History of malignancy (except treated basal cell carcinoma of skin)
- •5. Known active infection at screening visit or at baseline (except fungal nail infection)
- •6. Infection requiring hospitalization or IV antibiotics within 6 weeks of baseline
- •7. Immunization with live vaccine within 6 weeks of baseline
- •8. History of recurrent or chronic infection
- •9. History of hepatitis B or C, syphilis, Human immunodeficiency virus (HIV) or Human T-lymphotropic virus (HTLV1/2) infections
- •10. Injection of target joint with glucocorticoids within 6 weeks of baseline
- •11. Hb<10g/dL; neutrophils< 2.00 x109/L; platelets <150x109/L; Alanine transaminase/Alkaline phosphatase (ALT/ALP)>2x upper limit of normal; elevated serum creatinine at screening visit
- •12. Major surgery within 8 weeks of baseline or planned within 3 months from baseline
- •13. Pregnancy, or women planning to become pregnant within the study period, or women who are breast feeding
- •14. Females or males of child bearing potential unwilling to use adequate contraception for duration of study
- •15. Patients taking anticoagulants
- •16. Hypersensitivity to local or systemic corticosteroid therapy or local anaesthetic
- •17. Poor venous access or medical condition precluding leukapheresis
Investigators
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