| Primary | Number of Participants Receiving Biological Agent as Monotherapy or in Combination With Conventional Synthesis Disease-modifying Anti-rheumatic Drugs (csDMARDs) Therapy | Biological agent monotherapy meant participants using a biological agent without concomitant csDMARDs. Biological agent monotherapy included biological agent only, biological agent + glucocorticoid, biological agent + non-steroidal anti-inflammatory drugs [NSAIDs], and biological agent + glucocorticoid + NSAIDs. | | Posted | | Number | | participants | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| | | Title | Denominators | Categories |
|---|
| Biological agent only | | | | Biological agent+ glucocorticoid | | | | Biological agent + NSAIDs | | |
| |
| Primary | Number of Participants Receiving a Biological Agent Concomitant With Other Drugs | Number of participants receiving treatment of a biological agent concomitant with the following drugs: glucocorticoid, NSAIDs, other external medicine, or concomitant glucocorticoid and concomitant NSAIDs. The same participant could use 2 or 3 of concomitant glucocorticoid, NSAIDs and other external medicine. | | Posted | | Number | | participants | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Primary | Number of Participants Receiving a Biological Agent as Monotherapy by Types of Biological Agents | Number of participants who received a biological agent as monotherapy is presented by biological agent (adalimumab, tocilizumab, etanercept, and infliximab). | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Number | | participants | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Primary | Average Weekly Dose of Treatment for Each Biological Agent | Average weekly dose of treatment of each biological agent (adalimumab, tocilizumab, etanercept, or infliximab) is presented. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with specified treatment of biological agent. | Posted | | Mean | Standard Deviation | milligrams (mg) per week | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Primary | Average Duration of Treatment for Each Biological Agent | Average duration of treatment of each biological agent (adalimumab, tocilizumab, etanercept, or infliximab) is presented. | Overall Population. n = participants with specified treatment of biological agent. | Posted | | Mean | Standard Deviation | weeks | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Primary | Number of Participants With Previous Use of the Same Biological Agent | Participants who used the same biological agent in the past and were using that same biological agent at the time of study enrollment. | | Posted | | Number | | participants | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Primary | Number of Participants With Reasons for Switching Types of Biological Agent Who Used a Different Biological Agent in the Past | Participants who used a different biological agent in the past and switched are shown by reason for switching. One participant could have switched types of biological agent due to multiple reasons. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Number | | participants | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Primary | Average Weekly Dose of Each Concomitant Glucocorticoid | Average weekly dose of each concomitant glucocorticoid (prednisone acetate, oral; betamethasone [BMZ] dipropionate and betamethasone sodium phosphate, intra-articular (IA) injection; and methylprednisolone, intravenous drip infusion, oral) is presented. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with specified concomitant glucocorticoid treatment. | Posted | | Mean | Standard Deviation | mg/week | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Primary | Average Duration of Treatment With Each Concomitant External Medicine | | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category. | Posted | | Mean | Standard Deviation | weeks | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| | |
| Primary | Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs | Number of participants using one concomitant csDMARD, two concomitant csDMARDs (methotrexate + hydroxychloroquine [HCQ], methotrexate + salazosulfapyridine [SASP], methotrexate+ leflunomide, SASP + HCQ, and other combinations), or three (or more) concomitant csDMARDs (methotrexate + SASP + HCQ, and other combinations) are presented. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Number | | participants | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Primary | Average Weekly Dose of Each Concomitant csDMARD | One participant could have received multiple concomitant csDMARDs treatment. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category. | Posted | | Mean | Standard Deviation | mg/week | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Primary | Average Duration of Treatment With Each Concomitant csDMARD | One participant could have received multiple concomitant csDMARDs treatment. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category. | Posted | | Mean | Standard Deviation | weeks | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Primary | Average Daily Dose of Each Currently Concomitant NSAIDs | One participant could have received multiple concomitant NSAIDs treatment. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category. | Posted | | Mean | Standard Deviation | mg/day | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Primary | Average Daily Dose of Each Previously Concomitant NSAIDs | One participant could have received multiple concomitant NSAIDs treatment. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category. | Posted | | Mean | Standard Deviation | mg/day | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | Number Participants With Past Medical History of Concurrent Chronic Disease, Tuberculosis, Hepatitis, and Imaging Manifestations of Joint Damage | | | Posted | | Number | | participants | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| | |
| Secondary | Weight | | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | kilograms | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| | |
| Secondary | Height | | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | centimeters (cm) | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| | |
| Secondary | Number of RA Related Operations | RA related operations also included prosthesis. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | RA related operations | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | RA Duration Since Diagnosis | RA duration = (the date of participants signing the informed consent form - date of RA diagnosis + 1) /365.25 | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | years | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | Number of Participants With RA Duration | Number of participants with RA duration of <= 6 months, >6 months and <= 3 years, >3 years and <= 10 years, and 10 years. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Number | | participants | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | Number of Participants With Concurrent RA Extra-articular Symptoms | Number of participants with concurrent RA extra-articular symptoms including RA subcutaneous nodule, RA vasculitis, interstitial pneumonia, Felty's syndrome, and other symptoms were presented. One participant could have more than one concurrent RA extra-articular symptoms. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Number | | participants | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | Number of Participants With Concurrent Interstitial Lung Disease Using Methotrexate | | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Number | | participants | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| | |
| Secondary | C-Reactive Protein (CRP) Values | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mg/L | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | Number of Participants With Abnormal CRP Values | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Central lab was not used in this study; the definitions of abnormal CRP followed participating hospitals' standardized criteria. Case report form (CRF) collected data as directly "normal" or "abnormal". | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Number | | participants | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | Erythrocyte Sedimentation Rate (ESR) Values | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mm/hr | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | Number of Participants With Abnormal ESR Values | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation. Central lab was not used in this study; the definitions of abnormal ESR followed participating hospitals' standardized criteria. CRF collected data as directly "normal" or "abnormal". | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Number | | participants | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | Hemoglobin Values | Hemoglobin levels were measured in gram per liter (g/L). Anemia was defined as an adult male with hemoglobin value <120 g/L or an adult female with hemoglobin value <110 g/L. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | g/L | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | Number of Participants With Anemia | Anemia was defined as an adult male with hemoglobin value <120 g/L or an adult female with hemoglobin value <110 g/L. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Number | | participants | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | Number of Participants With Positive Anti-cyclic Citrullinated Peptide (ACCP) Antibody | ACCP antibodies are important markers of bone erosion in RA. Central lab was not used in this study; the definitions of positive ACCP followed participating hospitals' standardized criteria. CRF collected data as "positive" or "negative" directly. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Number | | participants | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | Number of Participants With Positive Rheumatoid Factor (RF) | RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. Central lab was not used in this study; the definitions of positive RF followed participating hospitals' standardized criteria. CRF collected data as "positive" or "negative" directly. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Number | | participants | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | Triglyceride Values | Normal range for triglyceride is <1.7 millimoles per liter (mmol/L). | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | Number of Participants With Abnormal Triglyceride Values | Normal range for triglyceride is <1.7 mmol/L. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Number | | participants | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | Total Cholesterol Values | Normal range for total cholesterol is <5.2 mmol/L. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| | |
| Secondary | Number of Participants With Abnormal Total Cholesterol Values | Normal range for total cholesterol is <5.2 mmol/L. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Number | | participants | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | Swollen Joint Count (SJC) | Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28. | | Posted | | Mean | Standard Deviation | swollen joint count | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | Tender Joint Count (TJC) | Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28. | | Posted | | Mean | Standard Deviation | tender joint count | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | Disease Activity Score Based on 28-Joint Count (DAS28) | DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and Patient's Global Assessment (PtGA) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PtGA of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*PtGA of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | Number of Participants Experiencing High Disease Activity to Clinical Remission Using the DAS28 | DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*PtGA of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Number | | participants | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | Clinical Disease Activity Index (CDAI) Scores | The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and Physician's Global Assessment (PGA) assessed on 0-10 centimeter (cm) VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | Number of Participants Experiencing High Disease Activity to Clinical Remission Using the CDAI | The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Number | | participants | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | Simplified Disease Activity Index (SDAI) | The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | Number of Participants Experiencing High Disease Activity to Clinical Remission Using the SDAI | The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Number | | participants | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | Number of Participants With Duration of Treatment of Biological Agent | Number of participants with duration of treatment of biological agent <3 months, >= 3 to <6 months, >= 6 to <12 months, and >= 12 months. | | Posted | | Number | | participants | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
| |
| Secondary | DAS28 by Duration of Treatment of Biological Agent | DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*PtGA of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure in respective arms. | Posted | | Mean | Standard Deviation | units on a scale | | Day 1 (enrollment visit) | | | | ID | Title | Description |
|---|
| OG000 | Duration of Biological Treatment <3 Months | Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment <3 months. | | OG001 | Duration of Biological Treatment >=3 to <6 Months | Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment >=3 to <6 months. |
|
| Secondary | DAS28 by Biological Agent as Monotherapy or Combination With csDMARDs | Biological agent monotherapy meant participants using a biological agent without concomitant csDMARDs. DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*PtGA. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Day 1 (enrollment visit) | | | | ID | Title | Description |
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| OG000 | Biological Agent as Monotherapy | Participants were divided into two groups according to whether using biological agent (namely, biological agent concomitant with csDMARDs treatment group and biological agent without csDMARDs treatment group). This group included participants using biological agent without concomitant csDMARDs. | | OG001 | Biological Agent as Combination With csDMARDs |
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| Secondary | Physician's Global Assessment (PGA) of Disease Activity | PGA of disease activity was measured on a 0 to 10 centimeter (cm) VAS, with 0 cm = no disease activity and 10 cm = extreme disease activity. | | Posted | | Mean | Standard Deviation | cm | | Day 1 (enrollment visit) | | | | ID | Title | Description |
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| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
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| Secondary | Patient's Global Assessment (PtGA) of Disease Activity | PtGA of disease activity was measured on a 0 to 10 cm VAS, with 0 cm = very well controlled and 10 cm = very poorly controlled. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | cm | | Day 1 (enrollment visit) | | | | ID | Title | Description |
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| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
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| Secondary | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | The HAQ consists of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question has 4 response options, ranging from "no difficulty" to "unable to do", corresponding to scores from 0 to 3. HAQ total score = sum of each of the 20 items' scores, with a summary score ranging from 0 to 60, where higher score indicates greater disability. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Day 1 (enrollment visit) | | | | ID | Title | Description |
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| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
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| Secondary | Participant's Fatigue Assessment | Participants scored the fatigue on 10 cm VAS from 0 = no fatigue to 10 = very fatigue. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | cm | | Day 1 (enrollment visit) | | | | ID | Title | Description |
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| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
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| Secondary | Participant's Pain Assessment | Participants scored the intensity of pain produced by RA on 10 cm VAS from 0 = no pain to 10 = extreme pain. | Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | cm | | Day 1 (enrollment visit) | | | | ID | Title | Description |
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| OG000 | Overall Population | Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit). |
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