An Observational Study to Describe in Routine Clinical Practice the Treatment Patterns of Usage of Biological DMARDs in RA Patients.
- Conditions
- Rheumatoid Arthritis
- Interventions
- Other: Routine clinical practice
- Registration Number
- NCT02590562
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 808
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description RA patients treated with routine clinical practice Routine clinical practice Describe in routine clinical practice the treatment patterns of usage of biological DMARDs in patients suffering from RA including frequency of monotherapy, biological DMARDs usage status (types, dosage), concomitant DMARDs usage information (type and dosage)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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".
Number Participants With Past Medical History of Concurrent Chronic Disease, Tuberculosis, Hepatitis, and Imaging Manifestations of Joint Damage Day 1 (enrollment visit) 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.
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.
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.
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.
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.
Trial Locations
- Locations (15)
China-Janpan Friendship Hospital of Jilin University
🇨🇳Changchun, China
Beijing Jishutan Hospital; Rheumatology & Immunology
🇨🇳Beijing, China
Peking University Third Hospital
🇨🇳Beijing, China
Xinjiang Uygur Autonomous Region People Hospital
🇨🇳Ürümqi, China
Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, China
Peking University People's Hospital
🇨🇳Beijing, China
Peking University First Hospital
🇨🇳Beijing, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
🇨🇳Guangzhou, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
🇨🇳Xi'an, China
Tianjin Medical University General Hospital
🇨🇳Tianjin (天津), China
West China Hospital, Sichuan University
🇨🇳Chengdu, China
The Second Hospital of Shanxi Medical University
🇨🇳Taiyuan, China
Guanghua Hospital of Integrated Traditional Chinese and Western Medicine ( Guanghua Hospital)
🇨🇳Shanghai, China