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

September 19, 2024 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, placebo-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 Qing Re Huo Xue placebo combined with MTX for patients with active rheumatoid arthritis (RA).

Study Overview

Status

Completed

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 10g bid and MTX 10mg once a week for 24 weeks, or MTX plus QRHX placebo. The primary outcome is the bone marrow edema score in Outcome Measures in Rheumatology Clinical Trials RA MRI Scoring (OMERACT-RAMRIS) at week 24.

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • China
      • Beijing, China, 100053
        • Guang'anmen Hospital, China Academy of Chinese Medical Sciences

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

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) granule plus methotrexate (MTX)
QRHX granule 10g bid and methotrexate (MTX) 10 mg once a week for 24 weeks
Drug: Methotrexate
Oral methotrexate 10 mg per week for 24 weeks.
Other Names:
  • XINYI Pharm
Drug: Qing Re Huo Xue (QRHX) granule
Qing Re Huo Xue (QRHX) granule 10g bid for 24 weeks
Placebo Comparator: Qing Re Huo Xue (QRHX) granule placebo plus Methotrexate (MTX)
QRHX granule placebo 10g bid plus Methotrexate (MTX) 10mg once a week for 24 weeks
Drug: Methotrexate
Oral methotrexate 10 mg per week for 24 weeks.
Other Names:
  • XINYI Pharm
Drug: Qing Re Huo Xue (QRHX) granule placebo
Qing Re Huo Xue (QRHX) granule placebo 10g bid for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in bone marrow edema score from baseline at week 24 in OMERACT RAMRIS
Time Frame: week 0, week 24
Bone marrow edema score will be assessed by OMERACT-RAMRIS scoring system; minimum value: 0, maximum value: 75; higher scores mean a worse outcome.
week 0, week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in bone erosion score from baseline at week 24 in OMERACT RAMRIS
Time Frame: week 0, week 24
Bone erosion score will be assessed by OMERACT-RAMRIS scoring system; minimum value: 0, maximum value: 250; higher scores mean a worse outcome.
week 0, week 24
The proportion of participants with no progression in bone marrow edema and bone erosion
Time Frame: week 24
No progression in bone marrow edema and bone erosion at week 24 is defined as change in RAMRIS osteitis/erosion score ≤0.
week 24
The proportion of participants achieving ACR response (ACR20, ACR50, ACR70)
Time Frame: week 4, week 12, week 24
The proportion of participants achieving ACR response (ACR20, ACR50, ACR70)
week 4, week 12, week 24
Change in the 28-joint Disease Activity Score in erythrocyte sedimentation rate
Time Frame: week 0, week 4, week 12, week 24
The improvement of DAS28-ESR and proportion of subjects achieving remission was completed. The subjects achieving remission will be defined as DAS28-ESR <2.6.
week 0, week 4, week 12, week 24
Change in Clinical Disease Activity Index (CDAI)
Time Frame: week0, week4, week 12, week 24
The improvement of CDAI and proportion of subjects achieving remission was completed. The subjects achieving remission will be defined as CDAI <2.8.
week0, week4, week 12, week 24
Change in Chinese patient-reported activity index with rheumatoid arthritis (CPRI-RA)
Time Frame: week0, week 4, week 12, week 24
CPRI-RA,The self-rating scale consists of 11 items,Each item was rated 0, 1, 2 and 3 on the scale of asymptomatic to aggravating symptoms, respectively.
week0, week 4, week 12, week 24
Change in Health Assessment Questionnaire Disability Index (HAQ-DI)
Time Frame: week0, week4, week 12, week 24
The self-rating scale consists of 20 items,Each item was rated 0, 1, 2 and 3 on the scale of asymptomatic to aggravating symptoms, respectively. (range: 0 [best] to 3 [worst])
week0, week4, week 12, 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 (Actual)

November 14, 2019

Primary Completion (Actual)

June 28, 2022

Study Completion (Actual)

June 28, 2022

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)

September 23, 2024

Last Update Submitted That Met QC Criteria

September 19, 2024

Last Verified

September 1, 2024

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.

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