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Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj(K0202)

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: NCT04134169
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Kang Stem Biotech Co., Ltd.

Brief Summary:
Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj(K0202)

Condition or disease Intervention/treatment
Rheumatoid Arthritis Other: Not applicable(observational study)

Detailed Description:
A Multi-center, Open, Long-term Follow-up Study to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid arthritis: 5-year Results From the K0202 Extension Study

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Study Type : Observational
Estimated Enrollment : 33 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multi-center, Open, Long-term Follow-up Study to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis : 5-year Results From the K0202 Extension Study
Actual Study Start Date : October 2, 2019
Estimated Primary Completion Date : August 11, 2025
Estimated Study Completion Date : August 11, 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Rheumatoid arthritis Other: Not applicable(observational study)
Not applicable(observational study)




Primary Outcome Measures :
  1. Safety Assessment [ Time Frame: 5 years ]
    (Rate of Adverse Event, Number of Participants with Adverse Event)


Secondary Outcome Measures :
  1. 1. Efficacy as measured by ACR(American College of Rheumatology)20,50,70 reaction rate [ Time Frame: 5 years ]
  2. 2. Efficacy as measured by EULAR (European League Against Rheumatism)reaction rate [ Time Frame: 5 years ]
  3. change in DAS(Disease activity scores)28-ESR from baseline [ Time Frame: 5 years ]
    DAS range is from ≥ 3.2 (inactive) , >3.2 but ≤ 5.1(moderate), >5.1(very active)

  4. change in KHAQ(Korean Health assessment questionnaire) from baseline [ Time Frame: 5 years ]
    KHAQ range is from 0 (clear) to 60 (severe)

  5. change in CDAI (clinical disease activity index) from baseline [ Time Frame: 5 years ]
    CDAI range is from 0 (clear) to 76 (severe)

  6. change in 100mm Pain VAS(Visual analogue scale) from baseline [ Time Frame: 5 years ]
    100mm Pain VAS range is from 0 (clear) to 100 (severe)

  7. change in Modified Sharp/Van der Heijde Socre from baseline [ Time Frame: 5 years ]
    Modified Sharp/Van der Heijde Socre range is from 0 (clear) to 448 (severe)



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Moderate to Severe Rheumatoid arthritis
Criteria

Inclusion Criteria:

  1. Subject who enrolled K0202 Clinical Trial(parent study) and has been given more than one medication.
  2. Subjects who understand and voluntarily sign an informed consent form

Exclusion Criteria:

1. Any other condition which the investigator judges would make patient unsuitable for study participation


Information from the National Library of Medicine

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): NCT04134169


Contacts
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Contact: Jae Hun Jung +82-2-20367615 jhjung@kangstem.com
Contact: Jeong-hyang Woo jhwoo@kangstem.com

Locations
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Korea, Republic of
Seoul national University Boramae medical center Recruiting
Seoul, Korea, Republic of
Contact: Sanghui Kim    +82-2-8703969      
Sponsors and Collaborators
Kang Stem Biotech Co., Ltd.
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Responsible Party: Kang Stem Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT04134169    
Other Study ID Numbers: K0202-E
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases