Clinical trial NCT01646385: Study to Assess the Safety and Efficacy of Etanercept in Patients Treated Over the Long-term in Real-world Clinical Practice, Using Data Collected by the British Society of Rheumatology Biologics Registry
Official title: Long-term Safety and Efficacy of Etanercept in a UK Observational Cohort Study - a Retrospective Database Analysis of British Society of Rheumatology Biologics Registry (BSRBR) Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: observational
non-interventional
cohort
retrospective
register
rheumatoid arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-07-20
Enrollment: 6393
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients with a diagnosis of rheumatoid arthritis

Brief summary: This study will assess the rates of serious adverse events and death in adult rheumatoid arthritis patients treated with etanercept over the long-term in real-life clinical practice. It will also assess whether there is any difference in the rate of serious adverse events in patients trated with etanercept in comparision to patients treated with conventional disease-modifying anti-rheumatic drugs (DMARDs). The study will in addition quantify the efficacy of etanercept in this population by assessing the rates of important clinical outcomes such as changes in disease activity and disability/functioning.

Detailed description: patients recruited sequentially as seen in clinical practice

Eligibility criteria: Inclusion Criteria:

* adult
* rheumatoid arthritis
* group 1: initiating etanercept as first biologic therapy
* group 2: DAS28\<4.2, biologic naive and treated with non-biologic DMARDs

Exclusion Criteria:

* diagnosis of other inflammatory arthritis

Primary outcomes:
measure: Crude Incidence Rate of Malignancy
timeFrame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
measure: Crude Incidence Rate of Lymphoproliferative Malignancy (LM)
timeFrame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
measure: Crude Incidence Rate of Serious Infections
timeFrame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
measure: Crude Incidence Rate of Other Serious Adverse Events
timeFrame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
measure: Crude Incidence Rate of All-Cause Mortality
timeFrame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
Secondary outcomes:
measure: Percentage of Participants Who Switched to Other Therapy Following Etanercept Discontinuation
timeFrame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
measure: Time on Etanercept Therapy
timeFrame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
measure: Disease Activity Score Based on 28-Joints Count (DAS28) at Baseline
timeFrame: Baseline
measure: Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Year 1, 2, 3, 4, and 5
timeFrame: Baseline, Year 1, 2, 3, 4, 5
measure: Percentage of Participants With Remission and Low Disease Activity as Assessed by Disease Activity Score Based on 28-Joints Count (DAS28)
timeFrame: Year 1, 2, 3, 4, 5
measure: Time to Remission
timeFrame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
measure: Health Assessment Questionnaire (HAQ) Score at Baseline
timeFrame: Baseline
measure: Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Year 1, 2, and 3
timeFrame: Baseline, Year 1, 2, 3
measure: Percentage of Participants With Remission Based on Health Assessment Questionnaire (HAQ) Score
timeFrame: Year 1, 2, 3
measure: Health Assessment Questionnaire (HAQ) Score 6 Months Prior to And 6 Months Post-Switching Etanercept
timeFrame: 6 months prior to and 6 months post switching etanercept
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: