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

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

This observational study will describe the treatment patterns of usage of biological DMARDs in routine clinical practice and the demographics and RA disease characteristics in patients suffering from rheumatoid arthritis. Patients will be recruited and examined the same day when recruited. There will be no follow up visit or treatment period only one visit in this study.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Other: Routine clinical practice

• Study Type: Observational
• Enrollment (Actual): 808

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100044
    • Peking University People's Hospital
  • Beijing, China, 100083
    • Peking University Third Hospital
  • Beijing, China, 100034
    • Peking University First Hospital
  • Beijing, China, 100035
    • Beijing Jishutan Hospital; Rheumatology & Immunology
  • Changchun, China, 130031
    • China-Janpan Friendship Hospital of Jilin University
  • Chengdu, China, 610041
    • West China Hospital, Sichuan University
  • Chengdu, China, 610072
    • Sichuan Provincial People's Hospital
  • Guangzhou, China, 510515
    • Nanfang Hospital, Southern Medical University
  • Guangzhou, China, 510080
    • The First Affiliated Hospital, Sun Yat-sen University
  • Guangzhou, China, 510405
    • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
  • Shanghai, China, 200052
    • Guanghua Hospital of Integrated Traditional Chinese and Western Medicine ( Guanghua Hospital)
  • Taiyuan, China, 030001
    • The Second Hospital of Shanxi Medical University
  • Tianjin (天津), China, 300052
    • Tianjin Medical University General Hospital
  • Xi'an, China, 710061
    • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
  • Ürümqi, China, 830001
    • Xinjiang Uygur Autonomous Region People Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will include RA patients (according to ACR criteria) who are experiencing biologic treatment.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Other: Routine clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 (enrollment visit)
Number of Participants Receiving a Biological Agent Concomitant With Other Drugs	Number of participants receiving treatment of a biological agent concomitant with the following drugs: glucocorticoid, NSAIDs, other external medicine, or concomitant glucocorticoid and concomitant NSAIDs. The same participant could use 2 or 3 of concomitant glucocorticoid, NSAIDs and other external medicine.	Day 1 (enrollment visit)
Number of Participants Receiving a Biological Agent as Monotherapy by Types of Biological Agents	Number of participants who received a biological agent as monotherapy is presented by biological agent (adalimumab, tocilizumab, etanercept, and infliximab).	Day 1 (enrollment visit)
Average Weekly Dose of Treatment for Each Biological Agent	Average weekly dose of treatment of each biological agent (adalimumab, tocilizumab, etanercept, or infliximab) is presented.	Day 1 (enrollment visit)
Average Duration of Treatment for Each Biological Agent	Average duration of treatment of each biological agent (adalimumab, tocilizumab, etanercept, or infliximab) is presented.	Day 1 (enrollment visit)
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.	Day 1 (enrollment visit)
Number of Participants With Reasons for Switching Types of Biological Agent Who Used a Different Biological Agent in the Past	Participants who used a different biological agent in the past and switched are shown by reason for switching. One participant could have switched types of biological agent due to multiple reasons.	Day 1 (enrollment visit)
Average Weekly Dose of Each Concomitant Glucocorticoid	Average weekly dose of each concomitant glucocorticoid (prednisone acetate, oral; betamethasone [BMZ] dipropionate and betamethasone sodium phosphate, intra-articular (IA) injection; and methylprednisolone, intravenous drip infusion, oral) is presented.	Day 1 (enrollment visit)
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	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.	Day 1 (enrollment visit)
Average Weekly Dose of Each Concomitant csDMARD	One participant could have received multiple concomitant csDMARDs treatment.	Day 1 (enrollment visit)
Average Duration of Treatment With Each Concomitant csDMARD	One participant could have received multiple concomitant csDMARDs treatment.	Day 1 (enrollment visit)
Average Daily Dose of Each Currently Concomitant NSAIDs	One participant could have received multiple concomitant NSAIDs treatment.	Day 1 (enrollment visit)
Average Daily Dose of Each Previously Concomitant NSAIDs	One participant could have received multiple concomitant NSAIDs treatment.	Day 1 (enrollment visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	RA related operations also included prosthesis.	Day 1 (enrollment visit)
RA Duration Since Diagnosis	RA duration = (the date of participants signing the informed consent form - date of RA diagnosis + 1) /365.25	Day 1 (enrollment visit)
Number of Participants With RA Duration	Number of participants with RA duration of <= 6 months, >6 months and <= 3 years, >3 years and <= 10 years, and 10 years.	Day 1 (enrollment visit)
Number of Participants With Concurrent RA Extra-articular Symptoms	Number of participants with concurrent RA extra-articular symptoms including RA subcutaneous nodule, RA vasculitis, interstitial pneumonia, Felty's syndrome, and other symptoms were presented. One participant could have more than one concurrent RA extra-articular symptoms.	Day 1 (enrollment visit)
Number of Participants With Concurrent Interstitial Lung Disease Using Methotrexate		Day 1 (enrollment visit)
C-Reactive Protein (CRP) Values	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.	Day 1 (enrollment visit)
Number of Participants With Abnormal CRP Values	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Central lab was not used in this study; the definitions of abnormal CRP followed participating hospitals' standardized criteria. Case report form (CRF) collected data as directly "normal" or "abnormal".	Day 1 (enrollment visit)
Erythrocyte Sedimentation Rate (ESR) Values	ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation.	Day 1 (enrollment visit)
Number of Participants With Abnormal ESR Values	ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation. Central lab was not used in this study; the definitions of abnormal ESR followed participating hospitals' standardized criteria. CRF collected data as directly "normal" or "abnormal".	Day 1 (enrollment visit)
Hemoglobin Values	Hemoglobin levels were measured in gram per liter (g/L). Anemia was defined as an adult male with hemoglobin value <120 g/L or an adult female with hemoglobin value <110 g/L.	Day 1 (enrollment visit)
Number of Participants With Anemia	Anemia was defined as an adult male with hemoglobin value <120 g/L or an adult female with hemoglobin value <110 g/L.	Day 1 (enrollment visit)
Number of Participants With Positive Anti-cyclic Citrullinated Peptide (ACCP) Antibody	ACCP antibodies are important markers of bone erosion in RA. Central lab was not used in this study; the definitions of positive ACCP followed participating hospitals' standardized criteria. CRF collected data as "positive" or "negative" directly.	Day 1 (enrollment visit)
Number of Participants With Positive Rheumatoid Factor (RF)	RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. Central lab was not used in this study; the definitions of positive RF followed participating hospitals' standardized criteria. CRF collected data as "positive" or "negative" directly.	Day 1 (enrollment visit)
Triglyceride Values	Normal range for triglyceride is <1.7 millimoles per liter (mmol/L).	Day 1 (enrollment visit)
Number of Participants With Abnormal Triglyceride Values	Normal range for triglyceride is <1.7 mmol/L.	Day 1 (enrollment visit)
Total Cholesterol Values	Normal range for total cholesterol is <5.2 mmol/L.	Day 1 (enrollment visit)
Number of Participants With Abnormal Total Cholesterol Values	Normal range for total cholesterol is <5.2 mmol/L.	Day 1 (enrollment visit)
Swollen Joint Count (SJC)	Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28.	Day 1 (enrollment visit)
Tender Joint Count (TJC)	Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28.	Day 1 (enrollment visit)
Disease Activity Score Based on 28-Joint Count (DAS28)	DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and Patient's Global Assessment (PtGA) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PtGA of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*PtGA of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.	Day 1 (enrollment visit)
Number of Participants Experiencing High Disease Activity to Clinical Remission Using the DAS28	DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*PtGA of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.	Day 1 (enrollment visit)
Clinical Disease Activity Index (CDAI) Scores	The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and Physician's Global Assessment (PGA) assessed on 0-10 centimeter (cm) VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.	Day 1 (enrollment visit)
Number of Participants Experiencing High Disease Activity to Clinical Remission Using the CDAI	The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.	Day 1 (enrollment visit)
Simplified Disease Activity Index (SDAI)	The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.	Day 1 (enrollment visit)
Number of Participants Experiencing High Disease Activity to Clinical Remission Using the SDAI	The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.	Day 1 (enrollment visit)
Number of Participants With Duration of Treatment of Biological Agent	Number of participants with duration of treatment of biological agent <3 months, >= 3 to <6 months, >= 6 to <12 months, and >= 12 months.	Day 1 (enrollment visit)
DAS28 by Duration of Treatment of Biological Agent	DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*PtGA of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.	Day 1 (enrollment visit)
DAS28 by Biological Agent as Monotherapy or Combination With csDMARDs	Biological agent monotherapy meant participants using a biological agent without concomitant csDMARDs. DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*PtGA. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.	Day 1 (enrollment visit)
Physician's Global Assessment (PGA) of Disease Activity	PGA of disease activity was measured on a 0 to 10 centimeter (cm) VAS, with 0 cm = no disease activity and 10 cm = extreme disease activity.	Day 1 (enrollment visit)
Patient's Global Assessment (PtGA) of Disease Activity	PtGA of disease activity was measured on a 0 to 10 cm VAS, with 0 cm = very well controlled and 10 cm = very poorly controlled.	Day 1 (enrollment visit)
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score	The HAQ consists of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question has 4 response options, ranging from "no difficulty" to "unable to do", corresponding to scores from 0 to 3. HAQ total score = sum of each of the 20 items' scores, with a summary score ranging from 0 to 60, where higher score indicates greater disability.	Day 1 (enrollment visit)
Participant's Fatigue Assessment	Participants scored the fatigue on 10 cm VAS from 0 = no fatigue to 10 = very fatigue.	Day 1 (enrollment visit)
Participant's Pain Assessment	Participants scored the intensity of pain produced by RA on 10 cm VAS from 0 = no pain to 10 = extreme pain.	Day 1 (enrollment visit)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2013
• Primary Completion (Actual): August 31, 2014
• Study Completion (Actual): August 31, 2014

Study Registration Dates

• First Submitted: October 16, 2015
• First Submitted That Met QC Criteria: October 28, 2015
• First Posted (Estimate): October 29, 2015

Study Record Updates

• Last Update Posted (Actual): August 2, 2017
• Last Update Submitted That Met QC Criteria: June 27, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: ML28487