Trial of Ginsenoside Compound K (GCK) Tablet in Patients With Rheumatoid Arthritis

November 25, 2018 updated by: Zhejiang Hisun Pharmaceutical Co. Ltd.

A Phase Ib Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GCK in Rheumatoid Arthritis Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100010
        • Recruiting
        • Department of rheumatology
        • Contact:
          • Yin Su, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GCK 100 mg group
GCK 100 mg+ Placebo 200 mg GCK tablet 100 mg + Placebo tablet 100 mgX2 tablets, once daily for 12 weeks (oral)
Drug: GCK 100 mg + Placebo 200 mg
GCK 100 mg + Placebo 200 mg, oral, 12 weeks
Other Names:
  • GCK
Experimental: GCK 200 mg group
GCK 200 mg + Placebo 100 mg GCK tablet 100 mg X 2 tablets+ Placebo tablet 100 mg once daily for 12 weeks (oral)
Drug: GCK 200 mg + Placebo 100 mg
GCK 200 mg + Placebo 100 mg, oral, 12 weeks
Other Names:
  • GCK
Experimental: GCK 300 mg group
GCK tablet 300 mg GCK tablet 100 mgX3 tablets once daily for 12 weeks (oral)
Drug: GCK 300 mg
GCK 300 mg, oral, 12 weeks
Other Names:
  • GCK
Placebo Comparator: Placebo of GCK group
Placebo 300 mg Placebo tablet 100 mgX3 tablets, once daily for 12 weeks (oral)
Drug: Placebo 300mg
Placebo 300mg, oral, 12 weeks
Other Names:
  • Placebo of GCK

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects reaching (the American College of Rheumatology response criteria 20 (ACR 20)
Time Frame: Week 12
ACR 20 would be examined
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in DAS 28-CRP
Time Frame: Week 4/8/12
DAS 28-CRP would be assessed
Week 4/8/12
Proportion of subjects reaching ACR 20
Time Frame: Week 4/8
ACR 20 would be assessed
Week 4/8
Proportion of subjects reaching ACR 50 and 70
Time Frame: Time Frame: Week 4/8/12
ACR 50 and 70 would be assessed
Time Frame: Week 4/8/12
Change from baseline in ESR and CRP
Time Frame: Time Frame: Week 4/8/12
ESR and CRP would assessed
Time Frame: Week 4/8/12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhejiang Hisun Pharmaceutical Co. Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yin Su, PhD, Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 11, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 11, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HISUN-GCK-Ib-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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