Safety and Effectiveness of Biological DMARDs in Elderly Patients With Rheumatoid Arthritis

NCT01685918 | Unknown

• 1 other identifier: ederly_RA
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Study objectives

1. 1.Comparison of drug persistency rates between elderly RA patients and young RA patients with biological DMARDs
2. 2.Analysis of discontinuation reasons \& influencing factors of drug discontinuation in elderly RA patients and young RA patients
3. 3.Comparison of the occurrence of adverse events \& treatment outcomes between elderly RA patients and young RA patients

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; aged

Outcome Measures

Primary Outcomes (1)

• drug(biologics) persistency rates

  The tolerability in the two groups (elderly RA patients and young RA patients) will be estimated by drug persistency rates using the Kaplan-Meier method. Comparisons between the resultant curves will be made by log rank test.

  Patients who have received or are receiving biologic agents including infliximab, etanercept, adalimumab, rituximab from Dec.2000 to Dec.2010 will be enrolled.

Secondary Outcomes (1)

• Treatement response (HAQ, DAS28)

  Information of treatment, DAS28ESR, HAQ, laboratory data and SAEs, etc. will be collected at baseline and predefined time points of follow-up (0, 3 month and every 6 month). This prospective study will be progressed during three years.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1. Retrospective study: 425 patients with RA We will collect data of Korean patients with RA retrospectively. Subjects will be extracted from medical records of RA patients who had treated with biological DMARDs or are currently using biological DMARDs from Dec 2000 to Dec 2010. 2. Prospectively study: 203 patients with RA We will use the web-based registry of RA patients with biologic DMARDs. This prospective study will be progressed during three years. We will compare the response in elderly RA patients versus young RA patients, and evaluate the impact of old age on the response. The occurrence of adverse events during three years will be described.

You may qualify if:

• Retrospective study
• Patients who satisfy the 1987 ACR classification criteria for RA
• Patients with RA who have received or are receiving biologic agents including infliximab, etanercept, adalimumab, rituximab.
• Prospective study
• Patients who satisfy the 1987 ACR classification criteria for RA
• Patients with RA who have received or are receiving biologic agents including infliximab, etanercept, adalimumab, rituximab, abatacept.

You may not qualify if:

• Patients younger than eighteen
• Patients enrolled in clinical trials
• For the prospective study: Sex and Reproductive Status
• WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 10 weeks after the last dose of study drug.
• Women who are pregnant or breastfeeding.
• Women with a positive pregnancy test on enrollment

Sponsors & Collaborators

• Hanyang University: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Hanyang University Hospital for rheumatic disease

Seoul, Sung-dong Gu, 133-792, South Korea

RECRUITING

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

Study Officials

• Sang-cheol Bae, Director

  Hanyang University Hospital for Rheumatic Disease

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang-cheol Bae, Director

CONTACT

82-2-2290-8260; scbae@hanyang.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD, MPH

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 14, 2012
• Study Start: April 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2016
• Last Updated: September 14, 2012

Record last verified: 2012-09

Locations

KR (1)