Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis

November 18, 2019 updated by: Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis: A Randomized Controlled Trial

This study is a multicenter, randomized, double-blinded, controlled trial with two parallel arms. The aim of the study is to evaluate whether Chinese herbal medicine Qing Re Huo Xue (QRHX) combined with methotrexate (MTX) might be better than MTX alone for patients with active rheumatoid arthritis (RA).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To compare the efficacy and safety of Chinese herbal medicine Qing Re Huo Xue (QRHX) and methotrexate (MTX) for patients with active rheumatoid arthritis (RA), a multicenter, randomized controlled trial will be conducted. Two hundred and four patients with active RA will be randomly allocated (1:1) to treatment with QRHX 10mg bid and MTX 10 mg once a week for 24 weeks, or MTX plus dummy QRHX. The primary outcome is he OMERACT rheumatoid arthritis MRI scoring system (RAMRIS) at week 24.

Study Type

Interventional

Enrollment (Anticipated)

204

Phase

  • Phase 2
  • Phase 3

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

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject has had a confirmed diagnosis of rheumatoid arthritis according to 2010 ACR/EULAR RA classification criteria.
  2. Subject has a DAS28 CRP disease activity score of >3.2 at screening.
  3. Subject also experienced the following signs and symptoms: swelling, joint pain, and heat in the joints.
  4. Subject has had no prior exposure to oral glucocorticoids at a daily dose greater than 10 mg or to any biologic agents.
  5. Subject may has had previous exposure to nonsteroidal anti-inflammatory drugs (NSAIDs) prior to screening and must be on stable dose.

Exclusion Criteria:

  1. History or presence of a clinically significant medical disorder other than RA that, in the opinion of the investigator and medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
  2. Subject has inflammatory, rheumatological disorders other than RA, where arthritis may be a prominent feature.
  3. Subject has received treatment with the prohibited therapies listed in the protocol, or changes to those treatments, within the prescribed timeframe.
  4. Pregnant or nursing an infant or with a life partner who is pregnant, nursing, or planning to become pregnant.

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
Intervention / Treatment
Experimental: Qing Re Huo Xue (QRHX) plus methotrexate (MTX)
QRHX XXmg bid and methotrexate (MTX) 10 mg once a week for 24 weeks
Drug: Qing Re Huo Xue (QRHX)
Qing Re Huo Xue (QRHX) XXmg bid for 24 weeks
Other Names:
  • GAM
Drug: Methotrexate
Oral methotrexate 10 mg per week for 24 weeks.
Other Names:
  • XINYI Pharm
Active Comparator: Methotrexate (MTX) plus dummy Qing Re Huo Xue (QRHX)
Drug: Methotrexate
Oral methotrexate 10 mg per week for 24 weeks.
Other Names:
  • XINYI Pharm
Drug: dummy Qing Re Huo Xue (QRHX)
dummy Qing Re Huo Xue (QRHX) XXmg bid for 24 weeks
Other Names:
  • GAM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in OMERACT RAMRIS
Time Frame: week 24
Bone erosions will be assessed by OMERACT-RAMRIS scoring system
week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of ACR20
Time Frame: week 24
Percentage of Participants With American College of Rheumatology 20% (ACR20)
week 24
Percentage of ACR50
Time Frame: week 24
Percentage of Participants With American College of Rheumatology 50% (ACR50)
week 24
Percentage of ACR70
Time Frame: week 24
Percentage of Participants With American College of Rheumatology 70% (ACR70)
week 24
Change From Baseline in Modified Total Sharp X-Ray Score at Week 24
Time Frame: week 24
Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease
week 24
Chinese Patient-reported Activity Index with RA scale (PRO)
Time Frame: week 24
Patient-Reported Outcomes Scale,The self-rating scale consists of 12 items,Each item was rated 0, 1, 2 and 3 on the scale of asymptomatic to aggravating symptoms, respectively.
week 24

Collaborators and Investigators

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

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Investigators

  • Principal Investigator: Quan Jiang, M.D, Guang' anmen 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 (Anticipated)

November 1, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

November 14, 2019

First Submitted That Met QC Criteria

November 18, 2019

First Posted (Actual)

November 20, 2019

Study Record Updates

Last Update Posted (Actual)

November 20, 2019

Last Update Submitted That Met QC Criteria

November 18, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018YFC1705203

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.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Qing Re Huo Xue (QRHX)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe