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

12 september 2012 bijgewerkt door: Sang-Cheol Bae, Hanyang University

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

Studie Overzicht

Toestand

Onbekend

Conditie

Gedetailleerde beschrijving

  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

Studietype

Observationeel

Inschrijving (Verwacht)

600

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Korea, republiek van
    • Sung-dong Gu
      • Seoul, Sung-dong Gu, Korea, republiek van, 133-792
        • Werving
        • Hanyang University Hospital for rheumatic disease
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

  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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
drug(biologics) persistency rates
Tijdsspanne: Patients who have received or are receiving biologic agents including infliximab, etanercept, adalimumab, rituximab from Dec.2000 to Dec.2010 will be enrolled.
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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Treatement response (HAQ, DAS28)
Tijdsspanne: 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.
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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hanyang University

Medewerkers

Bristol-Myers Squibb

Onderzoekers

  • Hoofdonderzoeker: Sang-cheol Bae, Director, Hanyang University Hospital for rheumatic disease

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2012

Primaire voltooiing (Verwacht)

1 augustus 2013

Studie voltooiing (Verwacht)

1 augustus 2016

Studieregistratiedata

Eerst ingediend

12 september 2012

Eerst ingediend dat voldeed aan de QC-criteria

12 september 2012

Eerst geplaatst (Schatting)

14 september 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

14 september 2012

Laatste update ingediend die voldeed aan QC-criteria

12 september 2012

Laatst geverifieerd

1 september 2012

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ederly_RA

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