This observational study will describe the treatment patterns of usage of biological DMARDs in routine clinical practice and the demographics and RA disease characteristics in patients suffering from rheumatoid arthritis. Patients will be recruited and examined the same day when recruited. There will be no follow up visit or treatment period only one visit in this study.
Study Type
OBSERVATIONAL
Enrollment
808
Peking University First Hospital
Beijing, China
Beijing Jishutan Hospital; Rheumatology & Immunology
Beijing, China
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.
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
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).
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
Average Duration of Treatment for Each Biological Agent
Average duration of treatment of each biological agent (adalimumab, tocilizumab, etanercept, or infliximab) is presented.
Time frame: Day 1 (enrollment visit)
Number of Participants With Previous Use of the Same Biological Agent
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Peking University People's Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
China-Janpan Friendship Hospital of Jilin University
Changchun, China
West China Hospital, Sichuan University
Chengdu, China
Sichuan Provincial People's Hospital
Chengdu, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, China
Nanfang Hospital, Southern Medical University
Guangzhou, China
...and 5 more locations
Participants who used the same biological agent in the past and were using that same biological agent at the time of study enrollment.
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
Average Duration of Treatment With Each Concomitant External Medicine
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
Average Weekly Dose of Each Concomitant csDMARD
One participant could have received multiple concomitant csDMARDs treatment.
Time frame: Day 1 (enrollment visit)
Average Duration of Treatment With Each Concomitant csDMARD
One participant could have received multiple concomitant csDMARDs treatment.
Time frame: Day 1 (enrollment visit)
Average Daily Dose of Each Currently Concomitant NSAIDs
One participant could have received multiple concomitant NSAIDs treatment.
Time frame: Day 1 (enrollment visit)
Average Daily Dose of Each Previously Concomitant NSAIDs
One participant could have received multiple concomitant NSAIDs treatment.
Time frame: Day 1 (enrollment visit)
Number Participants With Past Medical History of Concurrent Chronic Disease, Tuberculosis, Hepatitis, and Imaging Manifestations of Joint Damage
Time frame: Day 1 (enrollment visit)
Weight
Time frame: Day 1 (enrollment visit)
Height
Time frame: Day 1 (enrollment visit)
Number of RA Related Operations
RA related operations also included prosthesis.
Time frame: Day 1 (enrollment visit)
RA Duration Since Diagnosis
RA duration = (the date of participants signing the informed consent form - date of RA diagnosis + 1) /365.25
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
Number of Participants With Concurrent Interstitial Lung Disease Using Methotrexate
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
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".
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
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".
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
Triglyceride Values
Normal range for triglyceride is \<1.7 millimoles per liter (mmol/L).
Time frame: Day 1 (enrollment visit)
Number of Participants With Abnormal Triglyceride Values
Normal range for triglyceride is \<1.7 mmol/L.
Time frame: Day 1 (enrollment visit)
Total Cholesterol Values
Normal range for total cholesterol is \<5.2 mmol/L.
Time frame: Day 1 (enrollment visit)
Number of Participants With Abnormal Total Cholesterol Values
Normal range for total cholesterol is \<5.2 mmol/L.
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)
Participant's Fatigue Assessment
Participants scored the fatigue on 10 cm VAS from 0 = no fatigue to 10 = very fatigue.
Time frame: Day 1 (enrollment visit)
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.
Time frame: Day 1 (enrollment visit)