Autologous tolerogenic dendritic cells for rheumatoid and inflammatory arthritis

Not Applicable

Completed

• Conditions: Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Inflammatory Arthritis; Musculoskeletal Diseases; Rheumatoid arthritis, unspecified

• Registration Number: ISRCTN87426082
• Lead Sponsor: ewcastle Hospitals Foundation NHS Trust (UK)

Brief Summary

1. 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/27117700 (added 21/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-27
• Study Completion: 2014-08-31
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified