Autologous Tolerogenic Dendritic Cells for Treatment of Patients With Rheumatoid Arthritis (TolDCfoRA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03337165|
Recruitment Status : Recruiting
First Posted : November 8, 2017
Last Update Posted : November 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Musculoskeletal Diseases Joint Disease Arthritis Arthritis, Rheumatoid Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases||Biological: tolerogenic dendritic cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety/Efficacy of Intra-articular Administration of Autologous Tolerogenic Dendritic Cells for Treatment of Patients With Rheumatoid Arthritis|
|Actual Study Start Date :||December 2016|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: tolerogenic dendritic cells
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
- Number of Participants experiencing AEs and SAEs following the intra-articular administration of tDCs. [ Time Frame: within 6 months of injection ]Occurrence and severity of adverse events following the intra-articular administration of tDCs will be evaluated within 6 months of injection.
- 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 ]Participants will assess acceptability of study specific procedures via an "acceptability questionnaire" administered at the last study visit.
- Change from Baseline in DAS28 Score. [ Time Frame: Baseline, 1, 3 and 6 months post treatment ]DAS28 calculated from the swollen joint count (SJC) and tender joint count (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour) and Patient Global Assessment of disease activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). A clinically meaningful improvement in DAS28 was defined as an improvement of 1.2 units.
- Change from Baseline in the Health Assessment Questionnaire (HAQ) [ Time Frame: Baseline, 1, 3 and 6 months post treatment ]Functional status (disability) of participants will be assessed using the Health Assessment Questionnaire (HAQ), a standard instrument used in RA.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03337165
|Contact: Alexey E Sizikov, PhD||+7 (383) email@example.com|
|Contact: Yuliya D Kurochkina||+7 (383) firstname.lastname@example.org|
|Institute of Fundamental and Clinical Immunology||Recruiting|
|Novosibirsk, Russian Federation, 630099|
|Contact: Elena R Chernykh, MD, PhD +7 (383) 236-03-29 email@example.com|
|Contact: Alexander A Ostanin, MD, PhD +7 (383) 236-03-29 firstname.lastname@example.org|
|Study Chair:||Elena R Chernykh, MD, PhD||Institute of Fundamental and Clinical Immunology|
|Principal Investigator:||Alexander A Ostanin, MD, PhD||Institute of Fundamental and Clinical Immunology|