Clinical trial NCT01685918: Safety and Effectiveness of Biological DMARDs in Elderly Patients With Rheumatoid Arthritis
Official title: Safety and Effectiveness of Biological DMARDs in Elderly Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
aged
Lead sponsor: Hanyang University
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2012-09-14
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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

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 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

Primary outcomes:
measure: drug(biologics) persistency rates
timeFrame: 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:
measure: Treatement response (HAQ, DAS28)
timeFrame: 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.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital for rheumatic disease
state: Sung-dong Gu
Study officials:
affiliation: Hanyang University Hospital for Rheumatic Disease
name: Sang-cheol Bae, Director
role: PRINCIPAL_INVESTIGATOR
References: