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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
204
Qing Re Huo Xue (QRHX) granule 10g bid for 24 weeks
Oral methotrexate 10 mg per week for 24 weeks.
Qing Re Huo Xue (QRHX) granule placebo 10g bid for 24 weeks
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, China
Change in bone marrow edema score from baseline at week 24 in OMERACT RAMRIS
Bone marrow edema score will be assessed by OMERACT-RAMRIS scoring system; minimum value: 0, maximum value: 75; higher scores mean a worse outcome.
Time frame: week 0, week 24
Change in bone erosion score from baseline at week 24 in OMERACT RAMRIS
Bone erosion score will be assessed by OMERACT-RAMRIS scoring system; minimum value: 0, maximum value: 250; higher scores mean a worse outcome.
Time frame: week 0, week 24
The proportion of participants with no progression in bone marrow edema and bone erosion
No progression in bone marrow edema and bone erosion at week 24 is defined as change in RAMRIS osteitis/erosion score ≤0.
Time frame: week 24
The proportion of participants achieving ACR response (ACR20, ACR50, ACR70)
The proportion of participants achieving ACR response (ACR20, ACR50, ACR70)
Time frame: week 4, week 12, week 24
Change in the 28-joint Disease Activity Score in erythrocyte sedimentation rate
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.
Time frame: week 0, week 4, week 12, week 24
Change in Clinical Disease Activity Index (CDAI)
The improvement of CDAI and proportion of subjects achieving remission was completed. The subjects achieving remission will be defined as CDAI \<2.8.
Time frame: week0, week4, week 12, week 24
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Change in Chinese patient-reported activity index with rheumatoid arthritis (CPRI-RA)
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.
Time frame: week0, week 4, week 12, week 24
Change in Health Assessment Questionnaire Disability Index (HAQ-DI)
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 \[worst\])
Time frame: week0, week4, week 12, week 24