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

NCT02590562 | Completed Results

• 1 other identifier: ML28487
• Study Type: observational
• Target: 808
• Locations: 1 country
• Sites: 15

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (36)

• 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

  Day 1 (enrollment visit)

• RA Duration Since Diagnosis

  Day 1 (enrollment visit)

Study Arms (1)

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

Interventions

Routine clinical practice OTHER

RA patients treated with routine clinical practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (15)

Peking University First Hospital

Beijing, 100034, China

Location

Beijing Jishutan Hospital; Rheumatology & Immunology

Beijing, 100035, China

Location

Peking University People's Hospital

Beijing, 100044, China

Location

Peking University Third Hospital

Beijing, 100083, China

Location

China-Janpan Friendship Hospital of Jilin University

Changchun, 130031, China

Location

West China Hospital, Sichuan University

Chengdu, 610041, China

Location

Sichuan Provincial People's Hospital

Chengdu, 610072, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, 510080, China

Location

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, 510405, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, 510515, China

Location

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

Shanghai, 200052, China

Location

The Second Hospital of Shanxi Medical University

Taiyuan, 030001, China

Location

Tianjin Medical University General Hospital

Tianjin (天津), 300052, China

Location

Xinjiang Uygur Autonomous Region People Hospital

Ürümqi, 830001, China

Location

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

Xi'an, 710061, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: October 29, 2015
• Study Start: December 31, 2013
• Primary Completion: August 31, 2014
• Study Completion: August 31, 2014
• Last Updated: August 2, 2017
• Results First Posted: February 10, 2016

Record last verified: 2017-06

Locations

CN (15)