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| Name | Class |
|---|---|
| Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine | OTHER |
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Acupuncture is used and recommended by the WHO for the treatment of Rheumatoid Arthritis.
The molecular bases of this recommendation are not known, the investigators want to compare with the usage of high-throughput molecular technologies the variations occurring in patients treated with acupuncture and conventional treatment with the ones treated with conventional treatment only. The investigators observe the variations in blood and in the gut microbiome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) |
|
| Control | Active Comparator | Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methotrexate | Drug | methotrexate: 7.5mg/week to 15mg/week for 3 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| ACR20 Response Rate at 3 Weeks | ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant) | From baseline to 3 weeks |
| ACR20 Response Rate at 3 Months | ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant) | From baseline to three months |
| Measure | Description | Time Frame |
|---|---|---|
| ACR50 Response Rate at 3 Weeks | ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant) |
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Inclusion Criteria:
The patient should be diagnosed as the first or second stage of rheumatoid Arthritis (RA) and checked with X ray for additional diagnose.
diagnosed for RA according to ACR(1987)
the patient should be in the active stage of the disease, defined as：
Should not be resistant to MTX nor leflunomide
Blood test should satisfy:
should be positive for anti-cyclic citrullinated protein antibodies (anti-CCP).
should agree to sign the informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Nardini, PhD | Key laboratory of Computational Biology,Chines Academy of Sciences-Max Planck Institute-CAS MPG PICB | Study Chair |
| Christine Nardini, PhD | Consiglio Nazionale delle Ricerche Istituto per le Applicazioni del Calcolo "Mauro Picone" | Study Chair |
| Yuanhua Liu | Shanghai Institute of Biochemistry and Cell Biology, CAS, Shanghai, PRC | Principal Investigator |
| Yongying Liang | Guanghua Hospital, Shanghai, PRC | Principal Investigator |
| Xiaoyuan Zhou | Group of Clinical Genomic Networks, Shanghai Institutes for Biological Sciences, CAS-MPG, China | Principal Investigator |
| Jennifer E. Dent | Group of Clinical Genomic Networks, Shanghai Institutes for Biological Sciences, CAS-MPG, China | Principal Investigator |
| Ting Jiang | Department of Neurology, University of California, San Francisco, USA | Principal Investigator |
| Ding Qin | Guanghua Hospital, Shanghai, PRC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai GuangHua Hospital of integrated traditional and western medicine | Shanghai | Shanghai Municipality | 200052 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Liu, Y. et al. (2023). Wound Healing from Bench to Bedside: A PPPM Bridge Between Physical Therapies and Chronic Inflammation. In: Podbielska, H., Kapalla, M. (eds) Predictive, Preventive, and Personalised Medicine: From Bench to Bedside. Advances in Predictive, Preventive and Personalised Medicine, vol 17. Springer, Cham. https://doi.org/10.1007/978-3-031-34884-6_12 |
| Label | URL |
|---|---|
| Book chapter | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| GSE59526 | Individual Participant Data Set | View IPD |
Quality of biological sampling was not good enough to grant production of quality omic data
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| ID | Title | Description |
|---|---|---|
| FG000 | Acupuncture | Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months Acupuncture: 30 minutes acupuncture every other day for 3 months. Basic acupoints: Zusanli, st36; Taixi，KI3）; Shenxu, BL23 Additional acupoints due to personal condition: Waiguan，SJ5; Baxie，Ex-UE9;Yinlingquan，(SP9）; Quchi，LI11; Yanglingquan，GB34; Xuehai，SP10; Dazhu，BL11; Dazhui，DU14; Pixu，BL20. |
| FG001 | Control | Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Acupuncture | Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months Acupuncture: 30 minutes acupuncture every other day for 3 months. Basic acupoints: Zusanli, st36; Taixi，KI3）; Shenxu, BL23 Additional acupoints due to personal condition: Waiguan，SJ5; Baxie，Ex-UE9;Yinlingquan，(SP9）; Quchi，LI11; Yanglingquan，GB34; Xuehai，SP10; Dazhu，BL11; Dazhui，DU14; Pixu，BL20. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | ACR20 Response Rate at 3 Weeks | ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant) | Posted | Count of Participants | Participants | From baseline to 3 weeks |
|
up to 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acupuncture | Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months Acupuncture: 30 minutes acupuncture every other day for 3 months. Basic acupoints: Zusanli, st36; Taixi，KI3）; Shenxu, BL23 Additional acupoints due to personal condition: Waiguan，SJ5; Baxie，Ex-UE9;Yinlingquan，(SP9）; Quchi，LI11; Yanglingquan，GB34; Xuehai，SP10; Dazhu，BL11; Dazhui，DU14; Pixu，BL20. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DR. Christine Nardini | CNR IAC | +393386947833 | christine.nardini.rsrc@gmail.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008727 | Methotrexate |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D000077339 | Leflunomide |
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| non-steroidal anti-inflammatory drug (NSAID) |
| Drug |
NSAID: 100mg twice a day for 3 months |
|
| leflunomide | Drug | leflunomide: 20mg/day for 3 months |
|
| methotrexate | Drug | methotrexate: 7.5mg/week to 15mg/week for 3 months |
|
| non-steroidal anti-inflammatory drug (NSAID) | Drug | NSAID: 100mg twice a day for 3 months |
|
| leflunomide | Drug | leflunomide: 20mg/day for 3 months |
|
| Acupuncture | Procedure | 30 minutes acupuncture every other day for 3 months. Basic acupoints: Zusanli, st36; Taixi，KI3）; Shenxu, BL23 Additional acupoints due to personal condition: Waiguan，SJ5; Baxie，Ex-UE9;Yinlingquan，(SP9）; Quchi，LI11; Yanglingquan，GB34; Xuehai，SP10; Dazhu，BL11; Dazhui，DU14; Pixu，BL20. |
|
| From baseline to 3 weeks |
| ACR50 Response Rate at 3 Months | ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant) | From baseline to three months |
| ACR70 Response Rate at 3 Weeks | ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant) | From baseline to 3 weeks |
| ACR70 Response Rate at 3 Months | ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant) | From baseline to three months |
| DAS28 at Baseline | The DAS28 (disease activity score) considers 28 tender and swollen joint counts, general health (GH; patient assessment of disease activity using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst), plus levels of an acute phase reactant (either the level of erythrocyte sedimentation rate ESR (mm/h) or C-reactive protein CRP (mg/litre)). DAS28 values were calculated as follows: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96; DAS28 (ESR) = 0.56*√(TJC28)+0.28*√(SJC28)+0.014*GH+0.70*ln(ESR), where TJC = tender joint count and SJC = swollen joint count. The scale does not have bounds. DAS28 total score < 2,6 means remission DAS28 total score ranged between 2.6-3.2 means inactive disease; DAS28 total score ranged between 3.3-5.1 means moderate disease activity; DAS28 total score >5.1 means very active disease | At baseline |
| DAS28 at 3 Weeks | The DAS28 (disease activity score) considers 28 tender and swollen joint counts, general health (GH; patient assessment of disease activity using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst), plus levels of an acute phase reactant (either the level of erythrocyte sedimentation rate ESR (mm/h) or C-reactive protein CRP (mg/litre)). DAS28 values were calculated as follows: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96; DAS28 (ESR) = 0.56*√(TJC28)+0.28*√(SJC28)+0.014*GH+0.70*ln(ESR), where TJC = tender joint count and SJC = swollen joint count. The scale does not have bounds. DAS28 total score < 2,6 means remission DAS28 total score ranged between 0-3.2 means inactive disease; DAS28 total score ranged between 3.3-5.1 means moderate disease activity; DAS28 total score >5.1 means very active disease | At 3 weeks |
| DAS28 at 3 Months | The DAS28 (disease activity score) considers 28 tender and swollen joint counts, general health (GH; patient assessment of disease activity using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst), plus levels of an acute phase reactant (either the level of erythrocyte sedimentation rate ESR (mm/h) or C-reactive protein CRP (mg/litre)). DAS28 values were calculated as follows: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96; DAS28 (ESR) = 0.56*√(TJC28)+0.28*√(SJC28)+0.014*GH+0.70*ln(ESR), where TJC = tender joint count and SJC = swollen joint count. The scale does not have bounds. DAS28 total score < 2,6 means remission DAS28 total score ranged between 0-3.2 means inactive disease; DAS28 total score ranged between 3.3-5.1 means moderate disease activity; DAS28 total score >5.1 means very active disease | At 3 months |
| Youtao Lu |
| Group of Clinical Genomic Networks, Shanghai Institutes for Biological Sciences, CAS-MPG, China |
| Principal Investigator |
| Dongyi He | Guanghua Hospital, Shanghai, PRC | Study Director |
| BG001 | Control | Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| RF(IU/mL) | Rheumatoid Factor | Mean | Standard Deviation | IU/mL |
|
| CRP(mg/L) | C-reactive protein | The sum does not match the total due to missing data | Mean | Standard Deviation | mg/L |
|
| ESR（mm/h) | Erythrocyte Sedimentation Rate | Mean | Standard Deviation | mm/h |
|
| hemoglobin(g/L) | Mean | Standard Deviation | g/L |
|
| White cell number(10^9 cells/L) | Mean | Standard Deviation | 10^9 cells/L |
|
| neutrophile granulocyte(%) | Mean | Standard Deviation | % of cells |
|
| Lymphocyte(%) | Mean | Standard Deviation | % of cells |
|
| OG001 | Control | Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months |
|
|
| Primary | ACR20 Response Rate at 3 Months | ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant) | Posted | Count of Participants | Participants | From baseline to three months |
|
|
|
| Secondary | ACR50 Response Rate at 3 Weeks | ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant) | Posted | Count of Participants | Participants | From baseline to 3 weeks |
|
|
|
| Secondary | ACR50 Response Rate at 3 Months | ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant) | Posted | Count of Participants | Participants | From baseline to three months |
|
|
|
| Secondary | ACR70 Response Rate at 3 Weeks | ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant) | Posted | Count of Participants | Participants | From baseline to 3 weeks |
|
|
|
| Secondary | ACR70 Response Rate at 3 Months | ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant) | Posted | Count of Participants | Participants | From baseline to three months |
|
|
|
| Secondary | DAS28 at Baseline | The DAS28 (disease activity score) considers 28 tender and swollen joint counts, general health (GH; patient assessment of disease activity using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst), plus levels of an acute phase reactant (either the level of erythrocyte sedimentation rate ESR (mm/h) or C-reactive protein CRP (mg/litre)). DAS28 values were calculated as follows: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96; DAS28 (ESR) = 0.56*√(TJC28)+0.28*√(SJC28)+0.014*GH+0.70*ln(ESR), where TJC = tender joint count and SJC = swollen joint count. The scale does not have bounds. DAS28 total score < 2,6 means remission DAS28 total score ranged between 2.6-3.2 means inactive disease; DAS28 total score ranged between 3.3-5.1 means moderate disease activity; DAS28 total score >5.1 means very active disease | Posted | Mean | Standard Deviation | units on a scale | At baseline |
|
|
|
| Secondary | DAS28 at 3 Weeks | The DAS28 (disease activity score) considers 28 tender and swollen joint counts, general health (GH; patient assessment of disease activity using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst), plus levels of an acute phase reactant (either the level of erythrocyte sedimentation rate ESR (mm/h) or C-reactive protein CRP (mg/litre)). DAS28 values were calculated as follows: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96; DAS28 (ESR) = 0.56*√(TJC28)+0.28*√(SJC28)+0.014*GH+0.70*ln(ESR), where TJC = tender joint count and SJC = swollen joint count. The scale does not have bounds. DAS28 total score < 2,6 means remission DAS28 total score ranged between 0-3.2 means inactive disease; DAS28 total score ranged between 3.3-5.1 means moderate disease activity; DAS28 total score >5.1 means very active disease | Posted | Mean | Standard Deviation | units on a scale | At 3 weeks |
|
|
|
| Secondary | DAS28 at 3 Months | The DAS28 (disease activity score) considers 28 tender and swollen joint counts, general health (GH; patient assessment of disease activity using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst), plus levels of an acute phase reactant (either the level of erythrocyte sedimentation rate ESR (mm/h) or C-reactive protein CRP (mg/litre)). DAS28 values were calculated as follows: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96; DAS28 (ESR) = 0.56*√(TJC28)+0.28*√(SJC28)+0.014*GH+0.70*ln(ESR), where TJC = tender joint count and SJC = swollen joint count. The scale does not have bounds. DAS28 total score < 2,6 means remission DAS28 total score ranged between 0-3.2 means inactive disease; DAS28 total score ranged between 3.3-5.1 means moderate disease activity; DAS28 total score >5.1 means very active disease | Posted | Mean | Standard Deviation | units on a scale | At 3 months |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Control | Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) methotrexate: methotrexate: 7.5mg/week to 15mg/week for 3 months non-steroidal anti-inflammatory drug (NSAID): NSAID: 100mg twice a day for 3 months leflunomide: leflunomide: 20mg/day for 3 months | 0 | 4 | 0 | 4 |
If discussion include scientific publication there is no restriction
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |