Clinical trial NCT02590562: An Observational Study to Describe in Routine Clinical Practice the Treatment Patterns of Usage of Biological DMARDs in RA Patients.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-10-29
Enrollment: 808
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include RA patients (according to ACR criteria) who are experiencing biologic treatment.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Receiving Biological Agent as Monotherapy or in Combination With Conventional Synthesis Disease-modifying Anti-rheumatic Drugs (csDMARDs) Therapy
timeFrame: Day 1 (enrollment visit)
measure: Number of Participants Receiving a Biological Agent Concomitant With Other Drugs
timeFrame: Day 1 (enrollment visit)
measure: Number of Participants Receiving a Biological Agent as Monotherapy by Types of Biological Agents
timeFrame: Day 1 (enrollment visit)
measure: Average Weekly Dose of Treatment for Each Biological Agent
timeFrame: Day 1 (enrollment visit)
measure: Average Duration of Treatment for Each Biological Agent
timeFrame: Day 1 (enrollment visit)
measure: Number of Participants With Previous Use of the Same Biological Agent
timeFrame: Day 1 (enrollment visit)
measure: Number of Participants With Reasons for Switching Types of Biological Agent Who Used a Different Biological Agent in the Past
timeFrame: Day 1 (enrollment visit)
measure: Average Weekly Dose of Each Concomitant Glucocorticoid
timeFrame: Day 1 (enrollment visit)
measure: Average Duration of Treatment With Each Concomitant External Medicine
timeFrame: Day 1 (enrollment visit)
measure: Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs
timeFrame: Day 1 (enrollment visit)
measure: Average Weekly Dose of Each Concomitant csDMARD
timeFrame: Day 1 (enrollment visit)
measure: Average Duration of Treatment With Each Concomitant csDMARD
timeFrame: Day 1 (enrollment visit)
measure: Average Daily Dose of Each Currently Concomitant NSAIDs
timeFrame: Day 1 (enrollment visit)
measure: Average Daily Dose of Each Previously Concomitant NSAIDs
timeFrame: Day 1 (enrollment visit)
Secondary outcomes:
measure: Number Participants With Past Medical History of Concurrent Chronic Disease, Tuberculosis, Hepatitis, and Imaging Manifestations of Joint Damage
timeFrame: Day 1 (enrollment visit)
measure: Weight
timeFrame: Day 1 (enrollment visit)
measure: Height
timeFrame: Day 1 (enrollment visit)
measure: Number of RA Related Operations
timeFrame: Day 1 (enrollment visit)
measure: RA Duration Since Diagnosis
timeFrame: Day 1 (enrollment visit)
measure: Number of Participants With RA Duration
timeFrame: Day 1 (enrollment visit)
measure: Number of Participants With Concurrent RA Extra-articular Symptoms
timeFrame: Day 1 (enrollment visit)
measure: Number of Participants With Concurrent Interstitial Lung Disease Using Methotrexate
timeFrame: Day 1 (enrollment visit)
measure: C-Reactive Protein (CRP) Values
timeFrame: Day 1 (enrollment visit)
measure: Number of Participants With Abnormal CRP Values
timeFrame: Day 1 (enrollment visit)
measure: Erythrocyte Sedimentation Rate (ESR) Values
timeFrame: Day 1 (enrollment visit)
measure: Number of Participants With Abnormal ESR Values
timeFrame: Day 1 (enrollment visit)
measure: Hemoglobin Values
timeFrame: Day 1 (enrollment visit)
measure: Number of Participants With Anemia
timeFrame: Day 1 (enrollment visit)
measure: Number of Participants With Positive Anti-cyclic Citrullinated Peptide (ACCP) Antibody
timeFrame: Day 1 (enrollment visit)
measure: Number of Participants With Positive Rheumatoid Factor (RF)
timeFrame: Day 1 (enrollment visit)
measure: Triglyceride Values
timeFrame: Day 1 (enrollment visit)
measure: Number of Participants With Abnormal Triglyceride Values
timeFrame: Day 1 (enrollment visit)
measure: Total Cholesterol Values
timeFrame: Day 1 (enrollment visit)
measure: Number of Participants With Abnormal Total Cholesterol Values
timeFrame: Day 1 (enrollment visit)
measure: Swollen Joint Count (SJC)
timeFrame: Day 1 (enrollment visit)
measure: Tender Joint Count (TJC)
timeFrame: Day 1 (enrollment visit)
measure: Disease Activity Score Based on 28-Joint Count (DAS28)
timeFrame: Day 1 (enrollment visit)
measure: Number of Participants Experiencing High Disease Activity to Clinical Remission Using the DAS28
timeFrame: Day 1 (enrollment visit)
measure: Clinical Disease Activity Index (CDAI) Scores
timeFrame: Day 1 (enrollment visit)
measure: Number of Participants Experiencing High Disease Activity to Clinical Remission Using the CDAI
timeFrame: Day 1 (enrollment visit)
measure: Simplified Disease Activity Index (SDAI)
timeFrame: Day 1 (enrollment visit)
measure: Number of Participants Experiencing High Disease Activity to Clinical Remission Using the SDAI
timeFrame: Day 1 (enrollment visit)
measure: Number of Participants With Duration of Treatment of Biological Agent
timeFrame: Day 1 (enrollment visit)
measure: DAS28 by Duration of Treatment of Biological Agent
timeFrame: Day 1 (enrollment visit)
measure: DAS28 by Biological Agent as Monotherapy or Combination With csDMARDs
timeFrame: Day 1 (enrollment visit)
measure: Physician's Global Assessment (PGA) of Disease Activity
timeFrame: Day 1 (enrollment visit)
measure: Patient's Global Assessment (PtGA) of Disease Activity
timeFrame: Day 1 (enrollment visit)
measure: Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
timeFrame: Day 1 (enrollment visit)
measure: Participant's Fatigue Assessment
timeFrame: Day 1 (enrollment visit)
measure: Participant's Pain Assessment
timeFrame: Day 1 (enrollment visit)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Beijing Jishutan Hospital; Rheumatology & Immunology
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Changchun
country: China
facility: China-Janpan Friendship Hospital of Jilin University
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of Chinese Medicine
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
city: Shanghai
country: China
facility: Guanghua Hospital of Integrated Traditional Chinese and Western Medicine ( Guanghua Hospital)
city: Taiyuan
country: China
facility: The Second Hospital of Shanxi Medical University
city: Tianjin (天津)
country: China
facility: Tianjin Medical University General Hospital
city: Xi'an
country: China
facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University
city: Ürümqi
country: China
facility: Xinjiang Uygur Autonomous Region People Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: