Clinical trial NCT04170504: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Qing Re Huo Xue
Methotrexate
Randomized controlled trial
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in bone marrow edema score from baseline at week 24 in OMERACT RAMRIS
timeFrame: week 0, week 24
Secondary outcomes:
measure: Change in bone erosion score from baseline at week 24 in OMERACT RAMRIS
timeFrame: week 0, week 24
measure: The proportion of participants with no progression in bone marrow edema and bone erosion
timeFrame: week 24
measure: The proportion of participants achieving ACR response (ACR20, ACR50, ACR70)
timeFrame: week 4, week 12, week 24
measure: Change in the 28-joint Disease Activity Score in erythrocyte sedimentation rate
timeFrame: week 0, week 4, week 12, week 24
measure: Change in Clinical Disease Activity Index (CDAI)
timeFrame: week0, week4, week 12, week 24
measure: Change in Chinese patient-reported activity index with rheumatoid arthritis (CPRI-RA)
timeFrame: week0, week 4, week 12, week 24
measure: Change in Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: week0, week4, week 12, week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Study officials:
affiliation: Guang' anmen hospital
name: Quan Jiang, M.D
role: PRINCIPAL_INVESTIGATOR
References: