Back to resultsEfficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Qing Re Huo Xue (QRHX)
Methotrexate
dummy Qing Re Huo Xue (QRHX)
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Qing Re Huo Xue, Methotrexate, Randomized controlled trial
Eligibility Criteria
Inclusion Criteria:
- Subject has had a confirmed diagnosis of rheumatoid arthritis according to 2010 ACR/EULAR RA classification criteria.
- Subject has a DAS28 CRP disease activity score of >3.2 at screening.
- Subject also experienced the following signs and symptoms: swelling, joint pain, and heat in the joints.
- Subject has had no prior exposure to oral glucocorticoids at a daily dose greater than 10 mg or to any biologic agents.
- Subject may has had previous exposure to nonsteroidal anti-inflammatory drugs (NSAIDs) prior to screening and must be on stable dose.
Exclusion Criteria:
- 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.
- Subject has inflammatory, rheumatological disorders other than RA, where arthritis may be a prominent feature.
- Subject has received treatment with the prohibited therapies listed in the protocol, or changes to those treatments, within the prescribed timeframe.
- Pregnant or nursing an infant or with a life partner who is pregnant, nursing, or planning to become pregnant.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Qing Re Huo Xue (QRHX) plus methotrexate (MTX)
Methotrexate (MTX) plus dummy Qing Re Huo Xue (QRHX)
Arm Description
QRHX XXmg bid and methotrexate (MTX) 10 mg once a week for 24 weeks
Methotrexate (MTX) plus dummy Qing Re Huo Xue (QRHX)
Outcomes
Primary Outcome Measures
Change from baseline in OMERACT RAMRIS
Bone erosions will be assessed by OMERACT-RAMRIS scoring system
Secondary Outcome Measures
Percentage of ACR20
Percentage of Participants With American College of Rheumatology 20% (ACR20)
Percentage of ACR50
Percentage of Participants With American College of Rheumatology 50% (ACR50)
Percentage of ACR70
Percentage of Participants With American College of Rheumatology 70% (ACR70)
Change From Baseline in Modified Total Sharp X-Ray Score at Week 24
Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease
Chinese Patient-reported Activity Index with RA scale (PRO)
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.
Full Information
NCT ID
NCT04170504
First Posted
November 14, 2019
Last Updated
November 18, 2019
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04170504
Brief Title
Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis
Official Title
Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Qing Re Huo Xue, Methotrexate, Randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
204 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Qing Re Huo Xue (QRHX) plus methotrexate (MTX)
Arm Type
Experimental
Arm Description
QRHX XXmg bid and methotrexate (MTX) 10 mg once a week for 24 weeks
Arm Title
Methotrexate (MTX) plus dummy Qing Re Huo Xue (QRHX)
Arm Type
Active Comparator
Arm Description
Methotrexate (MTX) plus dummy Qing Re Huo Xue (QRHX)
Intervention Type
Drug
Intervention Name(s)
Qing Re Huo Xue (QRHX)
Other Intervention Name(s)
GAM
Intervention Description
Qing Re Huo Xue (QRHX) XXmg bid for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
XINYI Pharm
Intervention Description
Oral methotrexate 10 mg per week for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
dummy Qing Re Huo Xue (QRHX)
Other Intervention Name(s)
GAM
Intervention Description
dummy Qing Re Huo Xue (QRHX) XXmg bid for 24 weeks
Primary Outcome Measure Information:
Title
Change from baseline in OMERACT RAMRIS
Description
Bone erosions will be assessed by OMERACT-RAMRIS scoring system
Time Frame
week 24
Secondary Outcome Measure Information:
Title
Percentage of ACR20
Description
Percentage of Participants With American College of Rheumatology 20% (ACR20)
Time Frame
week 24
Title
Percentage of ACR50
Description
Percentage of Participants With American College of Rheumatology 50% (ACR50)
Time Frame
week 24
Title
Percentage of ACR70
Description
Percentage of Participants With American College of Rheumatology 70% (ACR70)
Time Frame
week 24
Title
Change From Baseline in Modified Total Sharp X-Ray Score at Week 24
Description
Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease
Time Frame
week 24
Title
Chinese Patient-reported Activity Index with RA scale (PRO)
Description
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.
Time Frame
week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has had a confirmed diagnosis of rheumatoid arthritis according to 2010 ACR/EULAR RA classification criteria.
Subject has a DAS28 CRP disease activity score of >3.2 at screening.
Subject also experienced the following signs and symptoms: swelling, joint pain, and heat in the joints.
Subject has had no prior exposure to oral glucocorticoids at a daily dose greater than 10 mg or to any biologic agents.
Subject may has had previous exposure to nonsteroidal anti-inflammatory drugs (NSAIDs) prior to screening and must be on stable dose.
Exclusion Criteria:
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.
Subject has inflammatory, rheumatological disorders other than RA, where arthritis may be a prominent feature.
Subject has received treatment with the prohibited therapies listed in the protocol, or changes to those treatments, within the prescribed timeframe.
Pregnant or nursing an infant or with a life partner who is pregnant, nursing, or planning to become pregnant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quan Jiang, M.D
Phone
+8613901081632
Ext
0
Email
doctorjq@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quan Jiang, M.D
Organizational Affiliation
Guang' anmen hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis
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