Early Rheumatoid Arthritis
Conditions
Keywords
Ginsenoside compound K tablet, Rheumatoid Arthritis, Phase Ib study
Brief summary
This is a phase Ib study to investigate the safety, pharmacokinetics and preliminary efficacy of ginsenoside compound K (GCK) tablets in patients with rheumatoid arthritis. This study is to be run in China involving 10-12 sites. It will enroll approximately 240 patients to ensure 128 randomized with active rheumatoid arthritis. The treatment period is 12 weeks and total study duration per patient is approximately 14 weeks.
Detailed description
In this double-blind, placebo-controlled, phase Ib study, 128 patients with active RA are planned to be enrolled and randomly assigned 1:1:1:1 to receive placebo, or different doses of GCK tablet (100/200/300 mg). This study will evaluate the safety, pharmacokinetics and preliminary efficacy of GCK tablets in patients with rheumatoid arthritis
Interventions
DRUGGCK 100 mg + Placebo 200 mg
GCK 100 mg + Placebo 200 mg, oral, 12 weeks
DRUGGCK 200 mg + Placebo 100 mg
GCK 200 mg + Placebo 100 mg, oral, 12 weeks
DRUGGCK 300 mg
GCK 300 mg, oral, 12 weeks
DRUGPlacebo 300mg
Placebo 300mg, oral, 12 weeks
Sponsors
Zhejiang Hisun Pharmaceutical Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blind
Intervention model description
Multiple Ascending Dose, Multiple Groups, Multiple Centers
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects reaching (the American College of Rheumatology response criteria 20 (ACR 20) | Week 12 | ACR 20 would be examined |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in DAS 28-CRP | Week 4/8/12 | DAS 28-CRP would be assessed |
| Proportion of subjects reaching ACR 20 | Week 4/8 | ACR 20 would be assessed |
| Proportion of subjects reaching ACR 50 and 70 | Time Frame: Week 4/8/12 | ACR 50 and 70 would be assessed |
| Change from baseline in ESR and CRP | Time Frame: Week 4/8/12 | ESR and CRP would assessed |
Countries
China
Contacts
Primary ContactJianwei Liao, Master
Backup ContactDong Xiao, PhD
Outcome results
None listed