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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Hanyang University
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sang-Cheol Bae, Hanyang University
ClinicalTrials.gov Identifier:
NCT01685918
First received: September 12, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

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

Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety and Effectiveness of Biological DMARDs in Elderly Patients With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Hanyang University:

Primary Outcome Measures:
  • drug(biologics) persistency rates [ Time Frame: Patients who have received or are receiving biologic agents including infliximab, etanercept, adalimumab, rituximab from Dec.2000 to Dec.2010 will be enrolled. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Treatement response (HAQ, DAS28) [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 600
Study Start Date: April 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Detailed 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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685918

Contacts
Contact: Sang-cheol Bae, Director 82-2-2290-8260 scbae@hanyang.ac.kr

Locations
Korea, Republic of
Hanyang University Hospital for rheumatic disease Recruiting
Seoul, Sung-dong Gu, Korea, Republic of, 133-792
Contact: Sang-cheol Bae, MD    82-2-2290-9230    scbae@hanyang.ac.kr   
Sponsors and Collaborators
Hanyang University
Bristol-Myers Squibb
Investigators
Principal Investigator: Sang-cheol Bae, Director Hanyang University Hospital for Rheumatic Disease
  More Information

No publications provided

Responsible Party: Sang-Cheol Bae, Professor, MD, PhD, MPH, Hanyang University
ClinicalTrials.gov Identifier: NCT01685918     History of Changes
Other Study ID Numbers: ederly_RA
Study First Received: September 12, 2012
Last Updated: September 12, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hanyang University:
Rheumatoid arthritis
aged

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 21, 2014