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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02590562
• Other study ID #: ML28487
• Status: Completed
• Phase: N/A
• First received: October 16, 2015
• Last updated: January 13, 2016
• Start date: December 2013
• Est. completion date: August 2014

Study information

• Verified date: January 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: China:CFDA
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 808
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Routine clinical practice

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
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).	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
Primary	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)	No
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.	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
Primary	Average Duration of Treatment With Each Concomitant External Medicine		Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
Primary	Average Weekly Dose of Each Concomitant csDMARD	One participant could have received multiple concomitant csDMARDs treatment.	Day 1 (enrollment visit)	No
Primary	Average Duration of Treatment With Each Concomitant csDMARD	One participant could have received multiple concomitant csDMARDs treatment.	Day 1 (enrollment visit)	No
Primary	Average Daily Dose of Each Currently Concomitant NSAIDs	One participant could have received multiple concomitant NSAIDs treatment.	Day 1 (enrollment visit)	No
Primary	Average Daily Dose of Each Previously Concomitant NSAIDs	One participant could have received multiple concomitant NSAIDs treatment.	Day 1 (enrollment visit)	No
Secondary	Number Participants With Past Medical History of Concurrent Chronic Disease, Tuberculosis, Hepatitis, and Imaging Manifestations of Joint Damage		Day 1 (enrollment visit)	No
Secondary	Weight		Day 1 (enrollment visit)	No
Secondary	Height		Day 1 (enrollment visit)	No
Secondary	Number of RA Related Operations	RA related operations also included prosthesis.	Day 1 (enrollment visit)	No
Secondary	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)	No
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.	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
Secondary	Number of Participants With Concurrent Interstitial Lung Disease Using Methotrexate		Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
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".	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
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".	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
Secondary	Triglyceride Values	Normal range for triglyceride is <1.7 millimoles per liter (mmol/L).	Day 1 (enrollment visit)	No
Secondary	Number of Participants With Abnormal Triglyceride Values	Normal range for triglyceride is <1.7 mmol/L.	Day 1 (enrollment visit)	No
Secondary	Total Cholesterol Values	Normal range for total cholesterol is <5.2 mmol/L.	Day 1 (enrollment visit)	No
Secondary	Number of Participants With Abnormal Total Cholesterol Values	Normal range for total cholesterol is <5.2 mmol/L.	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No
Secondary	Participant's Fatigue Assessment	Participants scored the fatigue on 10 cm VAS from 0 = no fatigue to 10 = very fatigue.	Day 1 (enrollment visit)	No
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.	Day 1 (enrollment visit)	No