Clinical trial NCT03618784: Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Rheumatoid Arthritis
Keywords: FURESTEM-RA Inj.
Rheumatoid Arthritis
Cell therapy
Lead sponsor: Kang Stem Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-08-07
Enrollment: 33
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Safety of FURESTEM-RA Inj. - number of adverse events
timeFrame: 4 weeks follow-up after treatment
Secondary outcomes:
measure: Efficacy as measured by ACR(American College of Rheumatology)20,50,70 reaction rate
timeFrame: 16 weeks follow-up after treatment
measure: Efficacy as measured by EULAR (European League Against Rheumatism)reaction rate
timeFrame: 16 weeks follow-up after treatment
measure: Efficacy as measured by DAS(Disease activity scores)28-ESR
timeFrame: 16 weeks follow-up after treatment
measure: Efficacy as measured by KHAQ(Korean Health assessment questionnaire)
timeFrame: 16 weeks follow-up after treatment
measure: Efficacy as measured by CDAI (clinical disease activity index)
timeFrame: 16 weeks follow-up after treatment
measure: Efficacy as measured by 100mm Pain VAS(Visual analogue scale)
timeFrame: 16 weeks follow-up after treatment
measure: Total number of use and consumed amount of rescue medicine
timeFrame: 16 weeks follow-up after treatment
measure: Change in Cytokine(TNF-a, Interleukin (IL)-1b, IL-4,IL-6,IL-8,IL-10,IL-13,IL-17A,IL-21,IL-22)
timeFrame: 16 weeks follow-up after treatment
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Gangdong Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Hospital attached to Soonchunhyang University
city: Seoul
country: Korea, Republic of
facility: Seoul national University Boramae
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: