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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03755258 |
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Date of registration:
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21/11/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Trial of Ginsenoside Compound K (GCK) Tablet in Patients With Rheumatoid Arthritis
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Scientific title:
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A Phase Ib Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GCK in Rheumatoid Arthritis Patients |
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Date of first enrolment:
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March 16, 2017 |
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Target sample size:
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128 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03755258 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1
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Countries of recruitment
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China
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Contacts
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Name:
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Jianwei Liao, Master |
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Address:
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Telephone:
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+8657688827869 |
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Email:
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jwliao@hisunpharm.com |
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Affiliation:
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Name:
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Yin Su, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Yin Su, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Peking University People's Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients have active RA as confirmed by the following criteria:
1. = 4 swollen joints and = 4 tender joints at screening and baseline using the
DAS28 joint count.
2. ESR = 28 mm/hour, or CRP = 1.5 times ULN.
- Patients on non-prohibited medications must receive stable dose for at least 2 weeks
prior to study drug administration and maintain an unchanged regimen during the study.
- Patients who are able and wish to sign the informed consent and comply with the
requirements of the study protocol.
Exclusion Criteria:
- Patients have prior exposure to any csDMARDs or bDMARDs.
- Patients have received corticosteroids, or Chinese medicine preparations such as
tripterygium wilfordii, total glucosides of paeony for RA treatment.
- Patients with fibromyalgia
- Patients diagnosed with any systemic inflammatory disease other than RA, including but
not limited to juvenile chronic arthritis, spondyloarthropathy, Crohn's disease,
ulcerative colitis, psoriatic arthritis, active vasculitis or gout, and siccasyndrome.
- Diagnosis of Felty Syndrome.
- Any major surgery has been performed within 8 weeks prior to the study, or will be
performed during the study, from which investigators believe posing an unacceptable
risk to the patient.
- Patient with cardiovascular, respiratory, liver, gastrointestinal, endocrine,
hematological, neurological or psychiatric disorders or any other serious and/or
unstable disease or medical history, or serious infection, and the investigators
believe that these diseases or history may pose risks in the case of taking research
drugs, or may interfere with the analysis of data.
- Patients who are unable to carry on normal activity or to do active work or unable to
take care of themselves.
- Patients with history of malignant tumors and lymphoproliferative diseases.
- Patients with active HBV or HCV or history of HIV infection.
- Active TB diagnosed during screening or with a history of active TB that has not been
appropriately treated.
- Patients who are currently pregnant or breastfeeding.
- Female patients of childbearing potential or male subjects with partners of
childbearing potential not willing to use a highly effective method of contraception
during the study and 28 days after last administration.
- Patient who participated in any investigational drug study within three months.
Specific laboratory abnormality including:
1. AST or ALT > 1.5 times ULN
2. Total bilirubin > 1.5 times ULN
3. Hemoglobin = 85 g/L
4. White blood cells count = 3.5×109/L
5. Absolute neutrophil count < 1.5×109/L
6. Lymphocyte Count < 0.75×109/L
7. Platelet count < 90×109/L
8. Creatinine > ULN
- Any other situation, in the opinion of the investigator, characterizes the
subject as not being a good candidate for the study.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Early Rheumatoid Arthritis
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Intervention(s)
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Drug: GCK 300 mg
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Drug: Placebo 300mg
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Drug: GCK 200 mg + Placebo 100 mg
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Drug: GCK 100 mg + Placebo 200 mg
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Primary Outcome(s)
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Proportion of subjects reaching (the American College of Rheumatology response criteria 20 (ACR 20)
[Time Frame: Week 12]
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Secondary Outcome(s)
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Change from baseline in ESR and CRP
[Time Frame: Time Frame: Week 4/8/12]
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Proportion of subjects reaching ACR 20
[Time Frame: Week 4/8]
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Change from baseline in DAS 28-CRP
[Time Frame: Week 4/8/12]
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Proportion of subjects reaching ACR 50 and 70
[Time Frame: Time Frame: Week 4/8/12]
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Secondary ID(s)
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HISUN-GCK-Ib-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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