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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01685918
• Other study ID #: ederly_RA
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2012
• Last updated: September 12, 2012
• Start date: April 2012
• Est. completion date: August 2016

Study information

• Verified date: September 2012
• Source: Hanyang University
• Contact: Sang-cheol Bae, Director
• Phone: 82-2-2290-8260
• Email: scbae[@]hanyang.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

Study objectives

1. Comparison of drug persistency rates between elderly RA patients and young RA patients with biological DMARDs

2. Analysis of discontinuation reasons & influencing factors of drug discontinuation in elderly RA patients and young RA patients

3. Comparison of the occurrence of adverse events & treatment outcomes between elderly RA patients and young RA patients

Description:

1. Retrospective study:

We will collect data of Korean patients with RA retrospectively. Subjects will be extracted from medical records of RA patients who had treated with TNF inhibitor or are currently using TNF inhibitor. Patients who have received or are receiving biologic agents including infliximab, etanercept, adalimumab, rituximab from Dec.2000 to Dec.2010 will be enrolled.

Data for this study which are sex, date of birth, previous and current medication, the results of laboratory test, disease activity of RA (DAS28ESR), comorbidity will be collected. Information of treatment, DAS28ESR, laboratory data and SAEs will be collected at baseline and predefined time points of follow-up (0, 3 month and recent follow-up data).

During the first year of starting our study, we will focus to evaluate tolerability, the reason of discontinuation in elderly RA patients through this retrospective study. Tolerance could be analyzed by examining drug persistency of biologic DMARDs with the reason that led to drug interruption, and the drug persistency curves will be compared in the two groups. The length of time that patients remain on the drug therapy represents a useful measure of the treatment effectiveness and tolerability. The reason of discontinuation will be evaluate as descriptive analysis. And factors influenced on drug discontinuation in elderly RA patients and young RA patients using Cox-proportional analysis.

2. Prospectively study:

We will use the data of patients of Hanyang University Hospital for Rheumatic Diseases in web-based registry of RA patients with biologic DMARDs. Patients who start on receiving biologic agents including infliximab, etanercept, adalimumab, rituximab, abatacept will be enrolled. At registration, sex, date of birth, previous and current medication, the results of laboratory test, disease activity of RA (DAS28ESR), HAQ, comorbidity, socioeconomic status, etc. will be collected. 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.

We will focus the response of biologic DMARDs and the occurrence of adverse event in elderly RA patients in this prospective study. The response could be evaluated with the change of DAS28ESR and functional disability (HAQ). We will compare the response in elderly RA patients versus young RA patients, and evaluate the impact of old age on the response using multiple logistic regression model with adjust various confounding factors. The occurrence of adverse events during three years will be described in two groups

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 2016
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. 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.

2. 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.

Exclusion Criteria:

1. Patients younger than eighteen

2. Patients enrolled in clinical trials

3. For the prospective study: Sex and Reproductive Status

1. 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.

2. Women who are pregnant or breastfeeding.

3. Women with a positive pregnancy test on enrollment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Hospital for rheumatic disease	Seoul	Sung-dong Gu

Sponsors (2)

Lead Sponsor	Collaborator
Hanyang University	Bristol-Myers Squibb

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Treatement response (HAQ, DAS28)	Treatments outcomes will be compared between two groups (elderly RA patients and young RA patients). The significance of differences in mean values of continuous variables will be assessed with Student's t-test. We will evaluate the impact of old age on the response using Cox proportional hazard analysis with adjust various confounding factors.	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.	No