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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04170504
• Other study ID #: 2018YFC1705203
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: November 2019
• Est. completion date: June 2021

Study information

• Verified date: August 2019
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Quan Jiang, M.D
• Phone: +8613901081632
• Email: doctorjq[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 204
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Qing Re Huo Xue (QRHX)
Qing Re Huo Xue (QRHX) XXmg bid for 24 weeks
• Methotrexate
Oral methotrexate 10 mg per week for 24 weeks.
• dummy Qing Re Huo Xue (QRHX)
dummy Qing Re Huo Xue (QRHX) XXmg bid for 24 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in OMERACT RAMRIS	Bone erosions will be assessed by OMERACT-RAMRIS scoring system	week 24
Secondary	Percentage of ACR20	Percentage of Participants With American College of Rheumatology 20% (ACR20)	week 24
Secondary	Percentage of ACR50	Percentage of Participants With American College of Rheumatology 50% (ACR50)	week 24
Secondary	Percentage of ACR70	Percentage of Participants With American College of Rheumatology 70% (ACR70)	week 24
Secondary	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	week 24
Secondary	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.	week 24