Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Interventions
- Registration Number
- NCT04170504
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 204
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Qing Re Huo Xue (QRHX) granule plus methotrexate (MTX) Qing Re Huo Xue (QRHX) granule QRHX granule 10g bid and methotrexate (MTX) 10 mg once a week for 24 weeks Qing Re Huo Xue (QRHX) granule plus methotrexate (MTX) Methotrexate QRHX granule 10g bid and methotrexate (MTX) 10 mg once a week for 24 weeks Qing Re Huo Xue (QRHX) granule placebo plus Methotrexate (MTX) Methotrexate QRHX granule placebo 10g bid plus Methotrexate (MTX) 10mg once a week for 24 weeks Qing Re Huo Xue (QRHX) granule placebo plus Methotrexate (MTX) Qing Re Huo Xue (QRHX) granule placebo QRHX granule placebo 10g bid plus Methotrexate (MTX) 10mg once a week for 24 weeks
- Primary Outcome Measures
Name Time Method Change in bone marrow edema score from baseline at week 24 in OMERACT RAMRIS 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.
- Secondary Outcome Measures
Name Time Method Change in bone erosion score from baseline at week 24 in OMERACT RAMRIS 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.
The proportion of participants with no progression in bone marrow edema and bone erosion week 24 No progression in bone marrow edema and bone erosion at week 24 is defined as change in RAMRIS osteitis/erosion score ≤0.
The proportion of participants achieving ACR response (ACR20, ACR50, ACR70) week 4, week 12, week 24 The proportion of participants achieving ACR response (ACR20, ACR50, ACR70)
Change in the 28-joint Disease Activity Score in erythrocyte sedimentation rate 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.
Change in Clinical Disease Activity Index (CDAI) 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.
Change in Chinese patient-reported activity index with rheumatoid arthritis (CPRI-RA) 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.
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) 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 \[worst\])
Trial Locations
- Locations (1)
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
🇨🇳Beijing, China