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

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Methotrexate; Drug: Qing Re Huo Xue (QRHX) granule; Drug: Qing Re Huo Xue (QRHX) granule placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04170504

2018YFC1705203

Details and patient eligibility

About

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).

Full 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.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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204 participants in 2 patient groups, including a placebo group

Qing Re Huo Xue (QRHX) granule plus methotrexate (MTX)

Experimental group

Description:

QRHX granule 10g bid and methotrexate (MTX) 10 mg once a week for 24 weeks

Treatment:

Drug: Qing Re Huo Xue (QRHX) granule

Drug: Methotrexate

Qing Re Huo Xue (QRHX) granule placebo plus Methotrexate (MTX)

Placebo Comparator group

Description:

QRHX granule placebo 10g bid plus Methotrexate (MTX) 10mg once a week for 24 weeks

Treatment:

Drug: Qing Re Huo Xue (QRHX) granule placebo

Drug: Methotrexate