NCT03337165

Brief Summary

Tolerogenic dendritic cell (tDC)-based clinical trials for the treatment of autoimmune diseases are now a reality. Clinical trials are currently exploring the effectiveness of tDC to treat of type 1 diabetes mellitus, rheumatoid arthritis, multiple sclerosis and Crohn's disease. The general objective of this study is to evaluate the safety and tolerability of a single intra-articular injection (into the knee joint) of autologous monocyte-derived dendritic cells generated in the presence of interferon-alpha (IFN-α)/granulocyte-macrophage colony-stimulating factor (GM-CSF) and tolerized with Dexamethasone in rheumatoid arthritis (RA) patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

2.4 years

First QC Date

November 3, 2017

Last Update Submit

September 11, 2019

Conditions

Musculoskeletal DiseasesJoint DiseaseArthritisArthritis, RheumatoidRheumatic DiseasesConnective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Keywords

Rheumatoid arthritisAuto-immune disordersTolerogenic Dendritic Cells

Outcome Measures

Primary Outcomes (1)

  • Number of Participants experiencing AEs and SAEs following the intra-articular administration of tDCs.

    Occurrence and severity of adverse events following the intra-articular administration of tDCs will be evaluated within 6 months of injection.

    within 6 months of injection

Secondary Outcomes (3)

  • Number of Participants Who Rated the Study and its Components as Partly or Completely Acceptable.

    At final study visit, 6 months post treatment

  • Change from Baseline in DAS28 Score.

    Baseline, 1, 3 and 6 months post treatment

  • Change from Baseline in the Health Assessment Questionnaire (HAQ)

    Baseline, 1, 3 and 6 months post treatment

Study Arms (1)

tolerogenic dendritic cells

EXPERIMENTAL

Each dose of autologous monocyte-derived dendritic cells generated in the presence of IFN-α/GM-CSF and tolerized with Dexamethasone (1x106, 3x106, 5x106, 8x106 and 10x106 cells in 2.0 mL sodium chloride 0.9% solution) will be administered in RA patients through intra-articular injection (into the knee joint).

Biological: tolerogenic dendritic cells

Interventions

tolerogenic dendritic cellsBIOLOGICAL

dose-escalation

tolerogenic dendritic cells

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Fundamental and Clinical Immunology

Novosibirsk, 630099, Russia

Location

MeSH Terms

Conditions

Musculoskeletal DiseasesJoint DiseasesArthritisArthritis, RheumatoidRheumatic DiseasesConnective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

  • Elena R Chernykh, MD, PhD

    Institute of Fundamental and Clinical Immunology

    STUDY CHAIR

  • Alexander A Ostanin, MD, PhD

    Institute of Fundamental and Clinical Immunology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Clinical Department

Study Record Dates

First Submitted

November 3, 2017

First Posted

November 8, 2017

Study Start

December 1, 2016

Primary Completion

May 1, 2019

Study Completion

August 1, 2019

Last Updated

September 13, 2019

Record last verified: 2019-09

Locations

RU(1)