An Observational Study to Describe in Routine Clinical Practice the Treatment Patterns of Usage of Biological DMARDs in RA Patients.

Overview

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.

Full Title of Study: “A Multi-center Cross-sectional Study on Treatment Patterns and Patient Characteristics in Rheumatoid Arthritis (RA) Patients Treated by Biological DMARDs in China”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: August 31, 2014

Interventions

  • Other: Routine clinical practice

Arms, Groups and Cohorts

  • RA patients treated with 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)

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants Receiving Biological Agent as Monotherapy or in Combination With Conventional Synthesis Disease-modifying Anti-rheumatic Drugs (csDMARDs) Therapy
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: Day 1 (enrollment visit)
  • Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs
    • Time Frame: 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
    • Time Frame: Day 1 (enrollment visit)
    • One participant could have received multiple concomitant csDMARDs treatment.
  • Average Duration of Treatment With Each Concomitant csDMARD
    • Time Frame: Day 1 (enrollment visit)
    • One participant could have received multiple concomitant csDMARDs treatment.
  • Average Daily Dose of Each Currently Concomitant NSAIDs
    • Time Frame: Day 1 (enrollment visit)
    • One participant could have received multiple concomitant NSAIDs treatment.
  • Average Daily Dose of Each Previously Concomitant NSAIDs
    • Time Frame: Day 1 (enrollment visit)
    • One participant could have received multiple concomitant NSAIDs treatment.

Secondary Measures

  • 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
    • Time Frame: Day 1 (enrollment visit)
    • RA related operations also included prosthesis.
  • RA Duration Since Diagnosis
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: Day 1 (enrollment visit)
  • C-Reactive Protein (CRP) Values
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: Day 1 (enrollment visit)
    • Normal range for triglyceride is <1.7 millimoles per liter (mmol/L).
  • Number of Participants With Abnormal Triglyceride Values
    • Time Frame: Day 1 (enrollment visit)
    • Normal range for triglyceride is <1.7 mmol/L.
  • Total Cholesterol Values
    • Time Frame: Day 1 (enrollment visit)
    • Normal range for total cholesterol is <5.2 mmol/L.
  • Number of Participants With Abnormal Total Cholesterol Values
    • Time Frame: Day 1 (enrollment visit)
    • Normal range for total cholesterol is <5.2 mmol/L.
  • Swollen Joint Count (SJC)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: Day 1 (enrollment visit)
    • Participants scored the fatigue on 10 cm VAS from 0 = no fatigue to 10 = very fatigue.
  • Participant’s Pain Assessment
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hoffmann-La Roche
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Trials, Study Director, Hoffmann-La Roche

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