Rheumatoid Arthritis
Conditions
Brief summary
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.
Interventions
Sponsors
Hoffmann-La Roche
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients at least 18 years of age. * Patients with a diagnosis of RA according to the revised ACR criteria. * Patients receiving treatment of launched biological DMARDs.
Exclusion criteria
* Patients who received biological DMARDs due to clinical trials or biologics not launched. * Patients who are considered not appropriate for study due to other reasons at physicians' discretion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Receiving Biological Agent as Monotherapy or in Combination With Conventional Synthesis Disease-modifying Anti-rheumatic Drugs (csDMARDs) Therapy | Day 1 (enrollment visit) | 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. |
| Number of Participants Receiving a Biological Agent Concomitant With Other Drugs | Day 1 (enrollment visit) | 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. |
| Number of Participants Receiving a Biological Agent as Monotherapy by Types of Biological Agents | Day 1 (enrollment visit) | Number of participants who received a biological agent as monotherapy is presented by biological agent (adalimumab, tocilizumab, etanercept, and infliximab). |
| Average Weekly Dose of Treatment for Each Biological Agent | Day 1 (enrollment visit) | Average weekly dose of treatment of each biological agent (adalimumab, tocilizumab, etanercept, or infliximab) is presented. |
| Average Duration of Treatment for Each Biological Agent | Day 1 (enrollment visit) | Average duration of treatment of each biological agent (adalimumab, tocilizumab, etanercept, or infliximab) is presented. |
| Number of Participants With Previous Use of the Same Biological Agent | Day 1 (enrollment visit) | Participants who used the same biological agent in the past and were using that same biological agent at the time of study enrollment. |
| Number of Participants With Reasons for Switching Types of Biological Agent Who Used a Different Biological Agent in the Past | Day 1 (enrollment visit) | 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. |
| Average Weekly Dose of Each Concomitant Glucocorticoid | Day 1 (enrollment visit) | 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. |
| Average Duration of Treatment With Each Concomitant External Medicine | Day 1 (enrollment visit) | — |
| Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs | Day 1 (enrollment visit) | 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. |
| Average Weekly Dose of Each Concomitant csDMARD | Day 1 (enrollment visit) | One participant could have received multiple concomitant csDMARDs treatment. |
| Average Duration of Treatment With Each Concomitant csDMARD | Day 1 (enrollment visit) | One participant could have received multiple concomitant csDMARDs treatment. |
| Average Daily Dose of Each Currently Concomitant NSAIDs | Day 1 (enrollment visit) | One participant could have received multiple concomitant NSAIDs treatment. |
| Average Daily Dose of Each Previously Concomitant NSAIDs | Day 1 (enrollment visit) | One participant could have received multiple concomitant NSAIDs treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Positive Anti-cyclic Citrullinated Peptide (ACCP) Antibody | Day 1 (enrollment visit) | 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. |
| Number of Participants With Positive Rheumatoid Factor (RF) | Day 1 (enrollment visit) | 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. |
| Triglyceride Values | Day 1 (enrollment visit) | Normal range for triglyceride is \<1.7 millimoles per liter (mmol/L). |
| Number of Participants With Abnormal Triglyceride Values | Day 1 (enrollment visit) | Normal range for triglyceride is \<1.7 mmol/L. |
| Total Cholesterol Values | Day 1 (enrollment visit) | Normal range for total cholesterol is \<5.2 mmol/L. |
| Number of Participants With Abnormal Total Cholesterol Values | Day 1 (enrollment visit) | Normal range for total cholesterol is \<5.2 mmol/L. |
| Swollen Joint Count (SJC) | Day 1 (enrollment visit) | 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. |
| Tender Joint Count (TJC) | Day 1 (enrollment visit) | 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. |
| Disease Activity Score Based on 28-Joint Count (DAS28) | Day 1 (enrollment visit) | 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. |
| Number of Participants Experiencing High Disease Activity to Clinical Remission Using the DAS28 | Day 1 (enrollment visit) | 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. |
| Clinical Disease Activity Index (CDAI) Scores | Day 1 (enrollment visit) | 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. |
| Number of Participants Experiencing High Disease Activity to Clinical Remission Using the CDAI | Day 1 (enrollment visit) | 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. |
| Simplified Disease Activity Index (SDAI) | Day 1 (enrollment visit) | 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. |
| Number of Participants Experiencing High Disease Activity to Clinical Remission Using the SDAI | Day 1 (enrollment visit) | 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. |
| Number of Participants With Duration of Treatment of Biological Agent | Day 1 (enrollment visit) | Number of participants with duration of treatment of biological agent \<3 months, \>= 3 to \<6 months, \>= 6 to \<12 months, and \>= 12 months. |
| DAS28 by Duration of Treatment of Biological Agent | Day 1 (enrollment visit) | 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. |
| DAS28 by Biological Agent as Monotherapy or Combination With csDMARDs | Day 1 (enrollment visit) | 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. |
| Number Participants With Past Medical History of Concurrent Chronic Disease, Tuberculosis, Hepatitis, and Imaging Manifestations of Joint Damage | Day 1 (enrollment visit) | — |
| Patient's Global Assessment (PtGA) of Disease Activity | Day 1 (enrollment visit) | 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. |
| Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Day 1 (enrollment visit) | 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. |
| Participant's Fatigue Assessment | Day 1 (enrollment visit) | Participants scored the fatigue on 10 cm VAS from 0 = no fatigue to 10 = very fatigue. |
| Participant's Pain Assessment | Day 1 (enrollment visit) | Participants scored the intensity of pain produced by RA on 10 cm VAS from 0 = no pain to 10 = extreme pain. |
| Physician's Global Assessment (PGA) of Disease Activity | Day 1 (enrollment visit) | 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. |
| Weight | Day 1 (enrollment visit) | — |
| Height | Day 1 (enrollment visit) | — |
| Number of RA Related Operations | Day 1 (enrollment visit) | RA related operations also included prosthesis. |
| RA Duration Since Diagnosis | Day 1 (enrollment visit) | RA duration = (the date of participants signing the informed consent form - date of RA diagnosis + 1) /365.25 |
| Number of Participants With RA Duration | Day 1 (enrollment visit) | Number of participants with RA duration of \<= 6 months, \>6 months and \<= 3 years, \>3 years and \<= 10 years, and 10 years. |
| Number of Participants With Concurrent RA Extra-articular Symptoms | Day 1 (enrollment visit) | 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. |
| Number of Participants With Concurrent Interstitial Lung Disease Using Methotrexate | Day 1 (enrollment visit) | — |
| C-Reactive Protein (CRP) Values | Day 1 (enrollment visit) | 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. |
| Number of Participants With Abnormal CRP Values | Day 1 (enrollment visit) | 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. |
| Erythrocyte Sedimentation Rate (ESR) Values | Day 1 (enrollment visit) | 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. |
| Number of Participants With Abnormal ESR Values | Day 1 (enrollment visit) | 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. |
| Hemoglobin Values | Day 1 (enrollment visit) | 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. |
| Number of Participants With Anemia | Day 1 (enrollment visit) | Anemia was defined as an adult male with hemoglobin value \<120 g/L or an adult female with hemoglobin value \<110 g/L. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 802 |
| Total | 802 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did Not Meet the Inclusion Criteria | 6 |
Baseline characteristics
| Characteristic | Overall Population |
|---|---|
| Age, Continuous | 49.0 years STANDARD_DEVIATION 13.89 |
| Age, Customized >40 to <=60 years | 402 participants |
| Age, Customized >60 years | 185 participants |
| Age, Customized greater than (>) 20 to <=40 years | 201 participants |
| Age, Customized less than or equal to (<=) 20 years | 12 participants |
| Sex: Female, Male Female | 652 Participants |
| Sex: Female, Male Male | 150 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 802 |
| serious Total, serious adverse events | 0 / 802 |
Outcome results
Primary
Average Daily Dose of Each Currently Concomitant NSAIDs
One participant could have received multiple concomitant NSAIDs treatment.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Average Daily Dose of Each Currently Concomitant NSAIDs | Imrecoxib (n=20) | 200.0 mg/day | Standard Deviation 0 |
| Overall Population | Average Daily Dose of Each Currently Concomitant NSAIDs | Ibuprofen (n=12) | 550.0 mg/day | Standard Deviation 173.21 |
| Overall Population | Average Daily Dose of Each Currently Concomitant NSAIDs | Aceclofenac (n=7) | 157.1 mg/day | Standard Deviation 53.45 |
| Overall Population | Average Daily Dose of Each Currently Concomitant NSAIDs | Lornoxicam (n=6) | 16.0 mg/day | Standard Deviation 0 |
| Overall Population | Average Daily Dose of Each Currently Concomitant NSAIDs | Loxoprofen sodium (n=54) | 143.9 mg/day | Standard Deviation 45.28 |
| Overall Population | Average Daily Dose of Each Currently Concomitant NSAIDs | Meloxicam (n=91) | 12.8 mg/day | Standard Deviation 3.45 |
| Overall Population | Average Daily Dose of Each Currently Concomitant NSAIDs | Nimesulide (n=18) | 186.1 mg/day | Standard Deviation 41.32 |
| Overall Population | Average Daily Dose of Each Currently Concomitant NSAIDs | Celecoxib (n=194) | 306.2 mg/day | Standard Deviation 100.07 |
| Overall Population | Average Daily Dose of Each Currently Concomitant NSAIDs | Diclofenac (n=31) | 130.6 mg/day | Standard Deviation 166.55 |
| Overall Population | Average Daily Dose of Each Currently Concomitant NSAIDs | Etoricoxib (n=26) | 86.5 mg/day | Standard Deviation 32.12 |
| Overall Population | Average Daily Dose of Each Currently Concomitant NSAIDs | Indometacin (n=1) | 75.0 mg/day | — |
Primary
Average Daily Dose of Each Previously Concomitant NSAIDs
One participant could have received multiple concomitant NSAIDs treatment.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Average Daily Dose of Each Previously Concomitant NSAIDs | Ibuprofen (n=8) | 525.0 mg/day | Standard Deviation 148.8 |
| Overall Population | Average Daily Dose of Each Previously Concomitant NSAIDs | Aceclofenac (n=2) | 150.0 mg/day | Standard Deviation 70.71 |
| Overall Population | Average Daily Dose of Each Previously Concomitant NSAIDs | Loxoprofen sodium (n=16) | 135.0 mg/day | Standard Deviation 46.48 |
| Overall Population | Average Daily Dose of Each Previously Concomitant NSAIDs | Meloxicam (n=18) | 13.1 mg/day | Standard Deviation 3.69 |
| Overall Population | Average Daily Dose of Each Previously Concomitant NSAIDs | Nimesulide (n=1) | 200.0 mg/day | — |
| Overall Population | Average Daily Dose of Each Previously Concomitant NSAIDs | Celecoxib (n=39) | 266.7 mg/day | Standard Deviation 95.51 |
| Overall Population | Average Daily Dose of Each Previously Concomitant NSAIDs | Diclofenac (n=12) | 83.3 mg/day | Standard Deviation 40.36 |
| Overall Population | Average Daily Dose of Each Previously Concomitant NSAIDs | Etoricoxib (n=3) | 60.0 mg/day | Standard Deviation 0 |
| Overall Population | Average Daily Dose of Each Previously Concomitant NSAIDs | Indometacin (n=1) | 75.0 mg/day | — |
Primary
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)
Population: Overall Population. n = participants with specified treatment of biological agent.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Average Duration of Treatment for Each Biological Agent | Adalimumab (n=60) | 12.7 weeks | Standard Deviation 19.39 |
| Overall Population | Average Duration of Treatment for Each Biological Agent | Tocilizumab (n=138) | 4.7 weeks | Standard Deviation 7.48 |
| Overall Population | Average Duration of Treatment for Each Biological Agent | Etanercept (n=535) | 25.5 weeks | Standard Deviation 47.02 |
| Overall Population | Average Duration of Treatment for Each Biological Agent | Infliximab (n=69) | 34.5 weeks | Standard Deviation 39.07 |
Primary
Average Duration of Treatment With Each Concomitant csDMARD
One participant could have received multiple concomitant csDMARDs treatment.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Average Duration of Treatment With Each Concomitant csDMARD | Iguratimod (n=6) | 260.8 weeks | Standard Deviation 121.84 |
| Overall Population | Average Duration of Treatment With Each Concomitant csDMARD | Cyclophosphamide (n=7) | 251.1 weeks | Standard Deviation 230.78 |
| Overall Population | Average Duration of Treatment With Each Concomitant csDMARD | Ciclosporin (n=2) | 448.0 weeks | Standard Deviation 554.37 |
| Overall Population | Average Duration of Treatment With Each Concomitant csDMARD | Methotrexate (n=468) | 443.7 weeks | Standard Deviation 845.76 |
| Overall Population | Average Duration of Treatment With Each Concomitant csDMARD | Leflunomide (n=296) | 413.4 weeks | Standard Deviation 578.53 |
| Overall Population | Average Duration of Treatment With Each Concomitant csDMARD | Chloroquine phosphate (n=1) | 95.2 weeks | — |
| Overall Population | Average Duration of Treatment With Each Concomitant csDMARD | Azathioprine (n=1) | 0.7 weeks | — |
| Overall Population | Average Duration of Treatment With Each Concomitant csDMARD | Sulfasalazine (n=45) | 429.1 weeks | Standard Deviation 1039.86 |
| Overall Population | Average Duration of Treatment With Each Concomitant csDMARD | Mycophenolate mofetil (n=2) | 10.2 weeks | Standard Deviation 4.45 |
| Overall Population | Average Duration of Treatment With Each Concomitant csDMARD | Minocycline (n=1) | 210.0 weeks | — |
| Overall Population | Average Duration of Treatment With Each Concomitant csDMARD | Penicillamine (n=8) | 768.8 weeks | Standard Deviation 1012.51 |
| Overall Population | Average Duration of Treatment With Each Concomitant csDMARD | Thalidomide (n=4) | 234.5 weeks | Standard Deviation 208.79 |
| Overall Population | Average Duration of Treatment With Each Concomitant csDMARD | Hydroxychloroquine (n=298) | 261.3 weeks | Standard Deviation 409.44 |
Primary
Average Duration of Treatment With Each Concomitant External Medicine
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Musk tiger bone plaster (n=1) | 10.0 weeks | — |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Baiyi anti-inflammatory analgesic plaster (n=1) | 1.0 weeks | — |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Tibetan medicine (n=1) | 24.0 weeks | — |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Flurbiprofen (n=2) | 4.5 weeks | Standard Deviation 4.95 |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Compound Nanxing analgesic plaster (n=1) | 1.0 weeks | — |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Indirect moxibustion (n=1) | 1.0 weeks | — |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Dogskin paste (n=2) | 5.5 weeks | Standard Deviation 4.95 |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Dogskin plaster (n=1) | 10.0 weeks | — |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Analgesic plaster for arthritis (n=4) | 90.5 weeks | Standard Deviation 83.35 |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Hantongle plaster (n=1) | 1.0 weeks | — |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Safflower oil (n=1) | 1.0 weeks | — |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Wong To Yick Winter Green Oil (n=1) | 40.0 weeks | — |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Activating collaterals Liniment (n=1) | 4.0 weeks | — |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Flavored Shuangbai Powder (n=16) | 16.9 weeks | Standard Deviation 27.99 |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Capsaicin (n=13) | 5.1 weeks | Standard Deviation 7.13 |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Kilo-Mile Medicine Oil (n=1) | 4.0 weeks | — |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Qingpeng ointment (n=5) | 40.8 weeks | Standard Deviation 39.76 |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Shuangbai powder (n=5) | 3.0 weeks | Standard Deviation 4.47 |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Diclofenac (n=32) | 7.8 weeks | Standard Deviation 26.39 |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Tianhe ostealgia plaster (n=1) | 4.0 weeks | — |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Ketoprofen (n=46) | 2.0 weeks | Standard Deviation 4.06 |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Xiaotong plaster (n=5) | 83.2 weeks | Standard Deviation 45.62 |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Anti-inflammatory analgesic ointment (n=1) | 1.1 weeks | — |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Antiphlogistic analgesic ointment (n=1) | 5.0 weeks | — |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Yunnan Baiyao plaster (n=3) | 59.0 weeks | Standard Deviation 84.54 |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Chinese patent medicine (n=2) | 2.0 weeks | Standard Deviation 0 |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Indometacin (n=1) | 4.0 weeks | — |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Musk analgesic spray (n=1) | 1.0 weeks | — |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Shexiang Zhuanggu plaster (n=1) | 3.0 weeks | — |
| Overall Population | Average Duration of Treatment With Each Concomitant External Medicine | Missing (n=1) | 1.0 weeks | — |
Primary
Average Weekly Dose of Each Concomitant csDMARD
One participant could have received multiple concomitant csDMARDs treatment.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Average Weekly Dose of Each Concomitant csDMARD | Iguratimod (n=8) | 46.9 mg/week | Standard Deviation 8.84 |
| Overall Population | Average Weekly Dose of Each Concomitant csDMARD | Cyclophosphamide (n=7) | 26.9 mg/week | Standard Deviation 18.68 |
| Overall Population | Average Weekly Dose of Each Concomitant csDMARD | Ciclosporin (n=2) | 75.0 mg/week | Standard Deviation 35.36 |
| Overall Population | Average Weekly Dose of Each Concomitant csDMARD | Methotrexate (n=473) | 1.4 mg/week | Standard Deviation 0.35 |
| Overall Population | Average Weekly Dose of Each Concomitant csDMARD | Leflunomide (n=298) | 15.4 mg/week | Standard Deviation 5.22 |
| Overall Population | Average Weekly Dose of Each Concomitant csDMARD | Chloroquine phosphate (n=1) | 250.0 mg/week | — |
| Overall Population | Average Weekly Dose of Each Concomitant csDMARD | Azathioprine (n=1) | 50.0 mg/week | — |
| Overall Population | Average Weekly Dose of Each Concomitant csDMARD | Sulfasalazine (n=45) | 1753.3 mg/week | Standard Deviation 693.26 |
| Overall Population | Average Weekly Dose of Each Concomitant csDMARD | Mycophenolate mofetil (n=2) | 625.0 mg/week | Standard Deviation 530.33 |
| Overall Population | Average Weekly Dose of Each Concomitant csDMARD | Minocycline (n=1) | 100.0 mg/week | — |
| Overall Population | Average Weekly Dose of Each Concomitant csDMARD | Penicillamine (n=8) | 343.8 mg/week | Standard Deviation 57.86 |
| Overall Population | Average Weekly Dose of Each Concomitant csDMARD | Thalidomide (n=4) | 75.0 mg/week | Standard Deviation 28.87 |
| Overall Population | Average Weekly Dose of Each Concomitant csDMARD | Hydroxychloroquine (n=300) | 340.3 mg/week | Standard Deviation 96.25 |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with specified concomitant glucocorticoid treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Average Weekly Dose of Each Concomitant Glucocorticoid | Prednisone acetate, oral (n=174) | 57.8 mg/week | Standard Deviation 31.93 |
| Overall Population | Average Weekly Dose of Each Concomitant Glucocorticoid | BMZ dipropionate and BMZ sodium phosphate, IA(n=2) | 3.8 mg/week | Standard Deviation 4.54 |
| Overall Population | Average Weekly Dose of Each Concomitant Glucocorticoid | Methylprednisolone, intravenous drip infusion(n=4) | 638.8 mg/week | Standard Deviation 368.61 |
| Overall Population | Average Weekly Dose of Each Concomitant Glucocorticoid | Methylprednisolone, oral (n=55) | 59.7 mg/week | Standard Deviation 151.6 |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with specified treatment of biological agent.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Population | Average Weekly Dose of Treatment for Each Biological Agent | Tocilizumab (n=136) | 94.5 milligrams (mg) per week | Standard Deviation 21.9 |
| Overall Population | Average Weekly Dose of Treatment for Each Biological Agent | Adalimumab (n=60) | 20.1 milligrams (mg) per week | Standard Deviation 6.41 |
| Overall Population | Average Weekly Dose of Treatment for Each Biological Agent | Etanercept (n=534) | 38.2 milligrams (mg) per week | Standard Deviation 15.64 |
| Overall Population | Average Weekly Dose of Treatment for Each Biological Agent | Infliximab (n=53) | 33.1 milligrams (mg) per week | Standard Deviation 23.55 |
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).
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Population | Number of Participants Receiving a Biological Agent as Monotherapy by Types of Biological Agents | Adalimumab | 4 participants |
| Overall Population | Number of Participants Receiving a Biological Agent as Monotherapy by Types of Biological Agents | Tocilizumab | 8 participants |
| Overall Population | Number of Participants Receiving a Biological Agent as Monotherapy by Types of Biological Agents | Etanercept | 63 participants |
| Overall Population | Number of Participants Receiving a Biological Agent as Monotherapy by Types of Biological Agents | Infliximab | 9 participants |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Population | Number of Participants Receiving a Biological Agent Concomitant With Other Drugs | Concomitant with glucocorticoid | 238 participants |
| Overall Population | Number of Participants Receiving a Biological Agent Concomitant With Other Drugs | Concomitant with NSAIDs | 450 participants |
| Overall Population | Number of Participants Receiving a Biological Agent Concomitant With Other Drugs | Concomitant with glucocorticoid and NSAIDs | 137 participants |
| Overall Population | Number of Participants Receiving a Biological Agent Concomitant With Other Drugs | Concomitant other external medicine | 153 participants |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Population | Number of Participants Receiving Biological Agent as Monotherapy or in Combination With Conventional Synthesis Disease-modifying Anti-rheumatic Drugs (csDMARDs) Therapy | Biological agent only | 44 participants |
| Overall Population | Number of Participants Receiving Biological Agent as Monotherapy or in Combination With Conventional Synthesis Disease-modifying Anti-rheumatic Drugs (csDMARDs) Therapy | Biological agent+ glucocorticoid | 9 participants |
| Overall Population | Number of Participants Receiving Biological Agent as Monotherapy or in Combination With Conventional Synthesis Disease-modifying Anti-rheumatic Drugs (csDMARDs) Therapy | Biological agent + NSAIDs | 26 participants |
| Overall Population | Number of Participants Receiving Biological Agent as Monotherapy or in Combination With Conventional Synthesis Disease-modifying Anti-rheumatic Drugs (csDMARDs) Therapy | Biological agent + glucocorticoid + NSAIDs | 5 participants |
| Overall Population | Number of Participants Receiving Biological Agent as Monotherapy or in Combination With Conventional Synthesis Disease-modifying Anti-rheumatic Drugs (csDMARDs) Therapy | Biological agent concomitant with csDMARDs | 718 participants |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Population | Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs | One csDMARDs | 354 participants |
| Overall Population | Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs | Two csDMARDs: Methotrexate + HCQ | 129 participants |
| Overall Population | Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs | Two csDMARDs: Methotrexate + SASP | 7 participants |
| Overall Population | Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs | Two csDMARDs: Methotrexate+ leflunomide | 83 participants |
| Overall Population | Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs | Two csDMARDs: SASP + HCQ | 9 participants |
| Overall Population | Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs | Two csDMARDs: Other combinations | 68 participants |
| Overall Population | Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs | Three(or more) csDMARDs: Methotrexate + SASP + HCQ | 10 participants |
| Overall Population | Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs | Three (or more) csDMARDs: Other combinations | 58 participants |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Population | Number of Participants With Previous Use of the Same Biological Agent | 58 participants |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Population | Number of Participants With Reasons for Switching Types of Biological Agent Who Used a Different Biological Agent in the Past | Adverse reaction | 13 participants |
| Overall Population | Number of Participants With Reasons for Switching Types of Biological Agent Who Used a Different Biological Agent in the Past | Economic reasons | 10 participants |
| Overall Population | Number of Participants With Reasons for Switching Types of Biological Agent Who Used a Different Biological Agent in the Past | Unsatisfactory efficacy | 54 participants |
| Overall Population | Number of Participants With Reasons for Switching Types of Biological Agent Who Used a Different Biological Agent in the Past | Improvement of the disease | 10 participants |
| Overall Population | Number of Participants With Reasons for Switching Types of Biological Agent Who Used a Different Biological Agent in the Past | Inconvenient administration | 2 participants |
| Overall Population | Number of Participants With Reasons for Switching Types of Biological Agent Who Used a Different Biological Agent in the Past | Voluntarily discontinuation | 7 participants |
| Overall Population | Number of Participants With Reasons for Switching Types of Biological Agent Who Used a Different Biological Agent in the Past | Other reasons | 6 participants |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Population | Clinical Disease Activity Index (CDAI) Scores | 20.2 units on a scale | Standard Deviation 15.25 |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Population | C-Reactive Protein (CRP) Values | 27.7 mg/L | Standard Deviation 33.91 |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Population | DAS28 by Biological Agent as Monotherapy or Combination With csDMARDs | 4.8 units on a scale | Standard Deviation 1.76 |
| Duration of Biological Treatment >=3 to <6 Months | DAS28 by Biological Agent as Monotherapy or Combination With csDMARDs | 4.3 units on a scale | Standard Deviation 1.47 |
p-value: 0.0108F test
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure in respective arms.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Population | DAS28 by Duration of Treatment of Biological Agent | 4.6 units on a scale | Standard Deviation 1.45 |
| Duration of Biological Treatment >=3 to <6 Months | DAS28 by Duration of Treatment of Biological Agent | 3.5 units on a scale | Standard Deviation 1.44 |
| Duration of Biological Treatment >=6 to <12 Months | DAS28 by Duration of Treatment of Biological Agent | 3.9 units on a scale | Standard Deviation 1.42 |
| Duration of Biological Treatment >=12 Months | DAS28 by Duration of Treatment of Biological Agent | 3.2 units on a scale | Standard Deviation 1.4 |
p-value: <0.0001F test
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Population | Disease Activity Score Based on 28-Joint Count (DAS28) | 4.4 units on a scale | Standard Deviation 1.52 |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Population | Erythrocyte Sedimentation Rate (ESR) Values | 42.4 mm/hr | Standard Deviation 31.1 |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Population | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | 11.9 units on a scale | Standard Deviation 13.44 |
Secondary
Height
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Population | Height | 161.6 centimeters (cm) | Standard Deviation 6.56 |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Population | Hemoglobin Values | 117.1 g/L | Standard Deviation 18.78 |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Population | Number of Participants Experiencing High Disease Activity to Clinical Remission Using the CDAI | High disease activity | 278 participants |
| Overall Population | Number of Participants Experiencing High Disease Activity to Clinical Remission Using the CDAI | Low disease activity | 207 participants |
| Overall Population | Number of Participants Experiencing High Disease Activity to Clinical Remission Using the CDAI | Remission | 43 participants |
| Overall Population | Number of Participants Experiencing High Disease Activity to Clinical Remission Using the CDAI | Moderate disease activity | 273 participants |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Population | Number of Participants Experiencing High Disease Activity to Clinical Remission Using the DAS28 | High disease activity | 135 participants |
| Overall Population | Number of Participants Experiencing High Disease Activity to Clinical Remission Using the DAS28 | Moderate disease activity | 174 participants |
| Overall Population | Number of Participants Experiencing High Disease Activity to Clinical Remission Using the DAS28 | Low disease activity | 51 participants |
| Overall Population | Number of Participants Experiencing High Disease Activity to Clinical Remission Using the DAS28 | Remission | 52 participants |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Population | Number of Participants Experiencing High Disease Activity to Clinical Remission Using the SDAI | High disease activity | 158 participants |
| Overall Population | Number of Participants Experiencing High Disease Activity to Clinical Remission Using the SDAI | Moderate disease activity | 117 participants |
| Overall Population | Number of Participants Experiencing High Disease Activity to Clinical Remission Using the SDAI | Low disease activity | 56 participants |
| Overall Population | Number of Participants Experiencing High Disease Activity to Clinical Remission Using the SDAI | Remission | 12 participants |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Population | Number of Participants With Abnormal CRP Values | 209 participants |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Population | Number of Participants With Abnormal ESR Values | 276 participants |
Secondary
Number of Participants With Abnormal Total Cholesterol Values
Normal range for total cholesterol is \<5.2 mmol/L.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Population | Number of Participants With Abnormal Total Cholesterol Values | 35 participants |
Secondary
Number of Participants With Abnormal Triglyceride Values
Normal range for triglyceride is \<1.7 mmol/L.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Population | Number of Participants With Abnormal Triglyceride Values | 47 participants |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Population | Number of Participants With Anemia | 147 participants |
Secondary
Number of Participants With Concurrent Interstitial Lung Disease Using Methotrexate
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Population | Number of Participants With Concurrent Interstitial Lung Disease Using Methotrexate | 5 participants |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Population | Number of Participants With Concurrent RA Extra-articular Symptoms | RA nodule | 18 participants |
| Overall Population | Number of Participants With Concurrent RA Extra-articular Symptoms | Vasculitis | 0 participants |
| Overall Population | Number of Participants With Concurrent RA Extra-articular Symptoms | Interstitial pneumonia | 22 participants |
| Overall Population | Number of Participants With Concurrent RA Extra-articular Symptoms | Felty's syndrome | 0 participants |
| Overall Population | Number of Participants With Concurrent RA Extra-articular Symptoms | Other symptoms | 2 participants |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Population | Number of Participants With Duration of Treatment of Biological Agent | >=3 to <6 months | 86 participants |
| Overall Population | Number of Participants With Duration of Treatment of Biological Agent | >=6 to <12 months | 96 participants |
| Overall Population | Number of Participants With Duration of Treatment of Biological Agent | >=12 months | 117 participants |
| Overall Population | Number of Participants With Duration of Treatment of Biological Agent | <3 months | 503 participants |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Population | Number of Participants With Positive Anti-cyclic Citrullinated Peptide (ACCP) Antibody | 144 participants |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Population | Number of Participants With Positive Rheumatoid Factor (RF) | 184 participants |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Population | Number of Participants With RA Duration | <=6 months | 176 participants |
| Overall Population | Number of Participants With RA Duration | >6 months and <=3 years | 80 participants |
| Overall Population | Number of Participants With RA Duration | >3 years and <=10 years | 59 participants |
| Overall Population | Number of Participants With RA Duration | 10 years | 42 participants |
Secondary
Number of RA Related Operations
RA related operations also included prosthesis.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Population | Number of RA Related Operations | 0.1 RA related operations | Standard Deviation 0.34 |
Secondary
Number Participants With Past Medical History of Concurrent Chronic Disease, Tuberculosis, Hepatitis, and Imaging Manifestations of Joint Damage
Time frame: Day 1 (enrollment visit)
Population: Overall Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Population | Number Participants With Past Medical History of Concurrent Chronic Disease, Tuberculosis, Hepatitis, and Imaging Manifestations of Joint Damage | Concurrent chronic disease | 275 participants |
| Overall Population | Number Participants With Past Medical History of Concurrent Chronic Disease, Tuberculosis, Hepatitis, and Imaging Manifestations of Joint Damage | Tuberculosis history | 2 participants |
| Overall Population | Number Participants With Past Medical History of Concurrent Chronic Disease, Tuberculosis, Hepatitis, and Imaging Manifestations of Joint Damage | Hepatitis history | 8 participants |
| Overall Population | Number Participants With Past Medical History of Concurrent Chronic Disease, Tuberculosis, Hepatitis, and Imaging Manifestations of Joint Damage | Imaging of joint damage | 279 participants |
Secondary
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)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Population | Participant's Fatigue Assessment | 3.7 cm | Standard Deviation 2.51 |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Population | Participant's Pain Assessment | 4.2 cm | Standard Deviation 2.44 |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Population | Patient's Global Assessment (PtGA) of Disease Activity | 4.4 cm | Standard Deviation 2.3 |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Population | Physician's Global Assessment (PGA) of Disease Activity | 4.2 cm | Standard Deviation 2.23 |
Secondary
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)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Population | RA Duration Since Diagnosis | 3.2 years | Standard Deviation 5.8 |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Population | Simplified Disease Activity Index (SDAI) | 27.2 units on a scale | Standard Deviation 18.09 |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Population | Swollen Joint Count (SJC) | 4.8 swollen joint count | Standard Deviation 6.06 |
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.
Time frame: Day 1 (enrollment visit)
Population: Overall Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Population | Tender Joint Count (TJC) | 6.7 tender joint count | Standard Deviation 7.21 |
Secondary
Total Cholesterol Values
Normal range for total cholesterol is \<5.2 mmol/L.
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Population | Total Cholesterol Values | 4.3 mmol/L | Standard Deviation 1.23 |
Secondary
Triglyceride Values
Normal range for triglyceride is \<1.7 millimoles per liter (mmol/L).
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Population | Triglyceride Values | 1.3 mmol/L | Standard Deviation 0.71 |
Secondary
Weight
Time frame: Day 1 (enrollment visit)
Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Population | Weight | 58.9 kilograms | Standard Deviation 10.55 |