Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Qing Re Huo Xue, Methotrexate, Randomized controlled trial
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.
Interventions
DRUGQing Re Huo Xue (QRHX) granule placebo
Qing Re Huo Xue (QRHX) granule placebo 10g bid for 24 weeks
DRUGQing Re Huo Xue (QRHX) granule
Qing Re Huo Xue (QRHX) granule 10g bid for 24 weeks
DRUGMethotrexate
Oral methotrexate 10 mg per week for 24 weeks.
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 \[worst\]) |
| 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. |
Countries
China
Outcome results
None listed