Autologous Tolerogenic Dendritic Cells for Treatment of Patients With Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03337165
• Date of registration: 03/11/2017
• Prospective Registration: No
• Primary sponsor: Russian Academy of Medical Sciences
• Public title: Autologous Tolerogenic Dendritic Cells for Treatment of Patients With Rheumatoid Arthritis TolDCfoRA
• Scientific title: Safety/Efficacy of Intra-articular Administration of Autologous Tolerogenic Dendritic Cells for Treatment of Patients With Rheumatoid Arthritis
• Date of first enrolment: December 2016
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03337165
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Russian Federation

Contacts

• Name: Elena R Chernykh, MD, PhD
• Affiliation: Institute of Fundamental and Clinical Immunology

• Name: Alexander A Ostanin, MD, PhD
• Affiliation: Institute of Fundamental and Clinical Immunology

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age 18 to 75 Years

- Patients with moderate to severe active RA (DAS28 >=3.2)

- At least 6 month's disease duration

- Synovitis of large joints (knee, elbow)

- Morning stiffness in the target joint = 30 minutes

- Stable dose of disease-modifying anti-rheumatic drugs (DMARD) for =16 weeks

- Patients must be able to tolerate all study procedures

- Patients must be willing to voluntarily give written Informed Consent to participate
in the study before any procedures are performed

- Patients must be willing to be available for all baseline, treatment and follow-up
examinations required by protocol

Exclusion Criteria:

- Injection of target joint with glucocorticoids within 6 weeks of baseline

- Known hypersensitivity to gentamicin or local anaesthetics

- Dementia, psychiatric disorders

- Renal dysfunctions

- Hemodynamic or respiratory instability

- HIV or uncontrolled bacterial, fungal, or viral infections

- Pregnancy

- Malignancy

- Participation in other clinical trials



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Immune System Diseases

Arthritis

Rheumatic Diseases

Arthritis, Rheumatoid

Autoimmune Diseases

Connective Tissue Diseases

Musculoskeletal Diseases

Joint Disease

Intervention(s)

Biological: tolerogenic dendritic cells

Primary Outcome(s)

Number of Participants experiencing AEs and SAEs following the intra-articular administration of tDCs. [Time Frame: within 6 months of injection]

Secondary Outcome(s)

Number of Participants Who Rated the Study and its Components as Partly or Completely Acceptable. [Time Frame: At final study visit, 6 months post treatment]

Change from Baseline in DAS28 Score. [Time Frame: Baseline, 1, 3 and 6 months post treatment]

Change from Baseline in the Health Assessment Questionnaire (HAQ) [Time Frame: Baseline, 1, 3 and 6 months post treatment]

Secondary ID(s)

IFCI-14/10/2016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors