Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2022
• Main ID: NCT03618784
• Date of registration: 24/07/2018
• Prospective Registration: No
• Primary sponsor: Kang Stem Biotech Co., Ltd.
• Public title: Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis
• Scientific title: A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase I/2a Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. for Moderate to Severe Rheumatoid Arthritis
• Date of first enrolment: July 11, 2018
• Target sample size: 33
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03618784
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

Korea, Republic of

Key inclusion & exclusion criteria

Inclusion Criteria:

1. of either gender, 19-80years old

2. Subjects must be diagnosed according to the 2010 ACR/EULAR criteria for at least 12
weeks duration.

3. Subjects must be diagnosed with ACR functional class I. II, III

4. = 6 tender joints, swollen joints (68 joint count) at Screening

5. Subject who has moderate to severe disease activity (DAS28-ESR>3.2) on screening visit

6. History of treatment for one of conventional DMARDs or biologic DMARDs or JAK
inhibitors AND people diagnosed with either (a) or (b) by a trained person, or people
that have potential side effects thus not qualified from using biologic DMARDs.

1. people that have no effect with permitted dose taking for more than 3 months

2. people with a history of side effects of relevant treatment

7. Subjects must be taking cDMARDs(including methotrexate, sulfasalazine,
hydroxychloroquine, leflunomide) or tacrolimus of stable dose More than 12 weeks
before baseline visit and be willing to remain on stable dose throughout the study

8. If subject is currently administering steroids everyday, when steroid dose is
converted into prednisolone oral dose, the subject should take a stable
dose(=10mg/day) over 4 weeks on screening visit

9. In case of taking NASAIDs, Tramadol patients with stable amount of medication at least
2 weeks before screening visit.

10. During screening visit , patients with an ESR result of 28mm/hr; patients with a
1.0mg/dL or greater in a CRP testing

11. Subject who understands and voluntarily sign an informed consent form

Exclusion Criteria:

1. Subjects who is diagnosed ACR function class IV Rheumatoid Arthritis

2. Patients who are judged by the PI(or Sub-I) to be unable to participate in clinical
trials due to uncontrolled or unstable cardiovascular disease or severe blood disease

3. Subjects who has AIDS, other rheumatic disease(Crohn's disease, systemic lupus
erythematosus, lyme disease, psoriatic arthritis, spondylarthropathy, infectious or
reactive arthritis, reiter's syndrome, etc.)

4. Prior use of bDMARDs, within the following windows prior to baseline

- 24 weeks for Rituximab

- 10 weeks for Abatacept, Golimumab, Certolizumab pegol, Tocilizumab

- 7 weeks for Infliximab

- 4 weeks for Etanercept

- 3 weeks for Tofacitinib, Baricitinib

5. Subject who has history of hypersensitivity, heavy metal poisoning, etc. to drugs
which is composed of similar components.

6. Subject who has treated intravenous, intramuscular steroid injection within 2 weeks
before screening visit or intra-articular steroid injection within 4 weeks before
screening visit

7. Subject who has administered ACTH(adrenocorticotropic hormone) agents within 4 weeks
before screening visit

8. Subject who has undergone administration of any investigational drug within 30 days
before screening visit.

9. Use of prohibited medication or inability to avoid the use of prohibited medication
during the study

10. Pregnant, breast-feeding women

11. A female or male in their childbearing ages that is not willing to take proper
contraceptive methods during a study

12. Subject who has sever dyshepatia (Serum creatinine level = 1.7mg/dl)

13. Subject who has severe renal dysfunction (ALT/AST/bilirubin value = 2 upper limit of
the normal range at screening test)

14. Any other condition which the PI Judges would make patient unsuitable for study
participation



Age minimum: 19 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Other: sterile saline

Biological: FURESTEM-RA Inj

Primary Outcome(s)

Safety of FURESTEM-RA Inj. - number of adverse events [Time Frame: 4 weeks follow-up after treatment]

Secondary Outcome(s)

Efficacy as measured by 100mm Pain VAS(Visual analogue scale) [Time Frame: 16 weeks follow-up after treatment]

Efficacy as measured by DAS(Disease activity scores)28-ESR [Time Frame: 16 weeks follow-up after treatment]

Total number of use and consumed amount of rescue medicine [Time Frame: 16 weeks follow-up after treatment]

Change in Cytokine(TNF-a, Interleukin (IL)-1b, IL-4,IL-6,IL-8,IL-10,IL-13,IL-17A,IL-21,IL-22) [Time Frame: 16 weeks follow-up after treatment]

Efficacy as measured by KHAQ(Korean Health assessment questionnaire) [Time Frame: 16 weeks follow-up after treatment]

Efficacy as measured by ACR(American College of Rheumatology)20,50,70 reaction rate [Time Frame: 16 weeks follow-up after treatment]

Efficacy as measured by CDAI (clinical disease activity index) [Time Frame: 16 weeks follow-up after treatment]

Efficacy as measured by EULAR (European League Against Rheumatism)reaction rate [Time Frame: 16 weeks follow-up after treatment]

Secondary ID(s)

K0202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors