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

Phase 1

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT03618784
• Lead Sponsor: Kang Stem Biotech Co., Ltd.

Brief Summary

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

Detailed Description

Phase 1: Single center, open Phase 2a : Multi-center, randomized, double-blind, parallel, placebo Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. for Moderate to Severe Rheumatoid arthritis

Study Timeline

• Study Start: 2018-07-11
• Study First Submitted: 2018-07-24
• Study First Submitted QC: 2018-08-06
• Study First Posted: 2018-08-07
• Primary Completion: 2021-10-05
• Study Completion: 2022-05-13
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-07
• Last Update Posted: 2022-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety of FURESTEM-RA Inj. - number of adverse events	4 weeks follow-up after treatment	Evaluate the number of adverse events Safety of FURESTEM-RA Inj.

Secondary Outcome Measures

Name	Time	Method
Efficacy as measured by EULAR (European League Against Rheumatism)reaction rate	16 weeks follow-up after treatment
Efficacy as measured by ACR(American College of Rheumatology)20,50,70 reaction rate	16 weeks follow-up after treatment
Efficacy as measured by KHAQ(Korean Health assessment questionnaire)	16 weeks follow-up after treatment	KHAQ range is from 0 (clear) to 60 (severe)
Efficacy as measured by 100mm Pain VAS(Visual analogue scale)	16 weeks follow-up after treatment	100mm Pain VAS range is from 0 (clear) to 100 (severe)
Efficacy as measured by DAS(Disease activity scores)28-ESR	16 weeks follow-up after treatment	DAS range is from ≥ 3.2 (inactive) , \>3.2 but ≤ 5.1(moderate), \>5.1(very active)
Efficacy as measured by CDAI (clinical disease activity index)	16 weeks follow-up after treatment	CDAI range is from 0 (clear) to 76 (severe)
Total number of use and consumed amount of rescue medicine	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)	16 weeks follow-up after treatment

Trial Locations

Locations (7)

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Gangdong Kyung Hee University Hospital; 🇰🇷 Seoul, Korea, Republic of

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Kyung Hee University Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul Hospital attached to Soonchunhyang University; 🇰🇷 Seoul, Korea, Republic of

Seoul national University Boramae; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of