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Rheumatoid ArthritisNCT02590562

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

An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 15 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Routine clinical practice
How many people
808 participants
Where
15 sitesChina
Study dates
31 Dec 2013to 31 Aug 2014
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

China15 sites
  • Peking University First Hospital

    Beijing, 100034

  • Beijing Jishutan Hospital; Rheumatology & Immunology

    Beijing, 100035

  • Peking University People's Hospital

    Beijing, 100044

  • Peking University Third Hospital

    Beijing, 100083

  • China-Janpan Friendship Hospital of Jilin University

    Changchun, 130031

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • Sichuan Provincial People's Hospital

    Chengdu, 610072

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, 510080

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, 510405

  • Nanfang Hospital, Southern Medical University

    Guangzhou, 510515

  • Guanghua Hospital of Integrated Traditional Chinese and Western Medicine ( Guanghua Hospital)

    Shanghai, 200052

  • The Second Hospital of Shanxi Medical University

    Taiyuan, 030001

  • Tianjin Medical University General Hospital

    Tianjin (天津), 300052

  • Xinjiang Uygur Autonomous Region People Hospital

    Ürümqi, 830001

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061

Other trials in China

About this study

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

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.

Being tested
Routine clinical practice
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Routine clinical practiceOther

Study groups in NCT02590562
Study groupRoleWhat they receive
RA patients treated with routine clinical practiceDescribe 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)
Receives: Other: Routine clinical practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 1 (enrollment visit)

  2. 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.

    Measured: Day 1 (enrollment visit)

  3. 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).

    Measured: Day 1 (enrollment visit)

  4. 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.

    Measured: Day 1 (enrollment visit)

  5. Average Duration of Treatment for Each Biological Agent

    Average duration of treatment of each biological agent (adalimumab, tocilizumab, etanercept, or infliximab) is presented.

    Measured: Day 1 (enrollment visit)

  6. 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.

    Measured: Day 1 (enrollment visit)

  7. 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.

    Measured: Day 1 (enrollment visit)

  8. 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.

    Measured: Day 1 (enrollment visit)

  9. Average Duration of Treatment With Each Concomitant External Medicine

    Measured: Day 1 (enrollment visit)

  10. 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.

    Measured: Day 1 (enrollment visit)

  11. Average Weekly Dose of Each Concomitant csDMARD

    One participant could have received multiple concomitant csDMARDs treatment.

    Measured: Day 1 (enrollment visit)

  12. Average Duration of Treatment With Each Concomitant csDMARD

    One participant could have received multiple concomitant csDMARDs treatment.

    Measured: Day 1 (enrollment visit)

  13. Average Daily Dose of Each Currently Concomitant NSAIDs

    One participant could have received multiple concomitant NSAIDs treatment.

    Measured: Day 1 (enrollment visit)

  14. Average Daily Dose of Each Previously Concomitant NSAIDs

    One participant could have received multiple concomitant NSAIDs treatment.

    Measured: Day 1 (enrollment visit)

Secondary outcomes (36)
  1. Number Participants With Past Medical History of Concurrent Chronic Disease, Tuberculosis, Hepatitis, and Imaging Manifestations of Joint Damage

    Measured: Day 1 (enrollment visit)

  2. Weight

    Measured: Day 1 (enrollment visit)

  3. Height

    Measured: Day 1 (enrollment visit)

  4. Number of RA Related Operations

    RA related operations also included prosthesis.

    Measured: Day 1 (enrollment visit)

  5. RA Duration Since Diagnosis

    RA duration = (the date of participants signing the informed consent form - date of RA diagnosis + 1) /365.25

    Measured: Day 1 (enrollment visit)

  6. 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.

    Measured: Day 1 (enrollment visit)

  7. 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.

    Measured: Day 1 (enrollment visit)

  8. Number of Participants With Concurrent Interstitial Lung Disease Using Methotrexate

    Measured: Day 1 (enrollment visit)

  9. 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.

    Measured: Day 1 (enrollment visit)

  10. 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".

    Measured: Day 1 (enrollment visit)

  11. 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.

    Measured: Day 1 (enrollment visit)

  12. 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".

    Measured: Day 1 (enrollment visit)

  13. 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.

    Measured: Day 1 (enrollment visit)

  14. 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.

    Measured: Day 1 (enrollment visit)

  15. 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.

    Measured: Day 1 (enrollment visit)

  16. 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.

    Measured: Day 1 (enrollment visit)

  17. Triglyceride Values

    Normal range for triglyceride is <1.7 millimoles per liter (mmol/L).

    Measured: Day 1 (enrollment visit)

  18. Number of Participants With Abnormal Triglyceride Values

    Normal range for triglyceride is <1.7 mmol/L.

    Measured: Day 1 (enrollment visit)

  19. Total Cholesterol Values

    Normal range for total cholesterol is <5.2 mmol/L.

    Measured: Day 1 (enrollment visit)

  20. Number of Participants With Abnormal Total Cholesterol Values

    Normal range for total cholesterol is <5.2 mmol/L.

    Measured: Day 1 (enrollment visit)

  21. 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.

    Measured: Day 1 (enrollment visit)

  22. 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.

    Measured: Day 1 (enrollment visit)

  23. 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.

    Measured: Day 1 (enrollment visit)

  24. 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.

    Measured: Day 1 (enrollment visit)

  25. 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.

    Measured: Day 1 (enrollment visit)

  26. 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.

    Measured: Day 1 (enrollment visit)

  27. 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.

    Measured: Day 1 (enrollment visit)

  28. 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.

    Measured: Day 1 (enrollment visit)

  29. 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.

    Measured: Day 1 (enrollment visit)

  30. 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.

    Measured: Day 1 (enrollment visit)

  31. 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.

    Measured: Day 1 (enrollment visit)

  32. 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.

    Measured: Day 1 (enrollment visit)

  33. 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.

    Measured: Day 1 (enrollment visit)

  34. 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.

    Measured: Day 1 (enrollment visit)

  35. Participant's Fatigue Assessment

    Participants scored the fatigue on 10 cm VAS from 0 = no fatigue to 10 = very fatigue.

    Measured: Day 1 (enrollment visit)

  36. 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.

    Measured: Day 1 (enrollment visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2015 (estimated)
  2. Study start31 Dec 2013
  3. Primary completion31 Aug 2014
  4. Study completion31 Aug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
808 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02590562
Sponsor's protocol ID
ML28487
Status last verified
Jun 2017
First submitted
16 Oct 2015
Last updated
2 Aug 2017

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 15 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2017.

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