- ICH GCP
- US Clinical Trials Registry
- 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
July 7, 2014 updated by: Pfizer
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
patients recruited sequentially as seen in clinical practice
Study Type
Observational
Enrollment (Actual)
6393
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
adult patients with a diagnosis of rheumatoid arthritis
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
etanercept
adult rheumatoid arthritis patients initiating therapy with etanercept as their first biologic therapy
|
use as per routine clinical practice
|
nbDMARD
biologic-naive adult rheumatoid arthritis patients with DAS28 >4.2 treated with non-biologic anti-rheumatic drugs(s).
|
use as per routine clinical practice (methotrexate, azathioprine, cyclophosphamide, cyclosporine, leflunomide, other)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Crude Incidence Rate of Malignancy
Time Frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
|
Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by mean follow-up in years).
Crude (unadjusted) incidence rate calculated as number of malignancy events divided by Participant-Year, multiplied by 1000.
|
Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
|
Crude Incidence Rate of Lymphoproliferative Malignancy (LM)
Time Frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
|
Participant-Year estimated by calculating all of years that participants in a study were followed (number of evaluable participants multiplied by mean follow-up in years).
Crude (unadjusted) incidence rate calculated as number of LMs divided by Participant-Year, multiplied by 1000.
Lymphoproliferative: medical condition characterized by the dysfunction of the immune system often resulting in excessive production of lymphocytes.
LMs included lymphoma, myeloma, and leukemia.
Adverse outcome was defined as 'lymphoproliferative malignancy' in the field [lymphopro] labeled by BSRBR.
|
Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
|
Crude Incidence Rate of Serious Infections
Time Frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
|
Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years).
Crude (unadjusted) incidence rate calculated as number of serious infections divided by Participant-Year, multiplied by 1000.
Serious infections included those infections which required intravenous antibiotics, hospitalization, or resulted in death.
Adverse outcome was defined as 'serious infection' in the field [serinf] labeled by BSRBR.
|
Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
|
Crude Incidence Rate of Other Serious Adverse Events
Time Frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
|
Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years).
Crude (unadjusted) incidence rate calculated as number of other serious adverse events divided by Participant-Year, multiplied by 1000.
Other serious adverse events were based on classifications assigned by the BSRBR and included cardiac serious adverse events (SAEs), central nervous system SAEs, and nonmalignant hematological SAEs.
|
Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
|
Crude Incidence Rate of All-Cause Mortality
Time Frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
|
Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years).
Crude (unadjusted) incidence rate calculated as number of deaths divided by Participant-Year, multiplied by 1000.
Death was recorded in the adverse outcomes table and in the consultant follow-up table.
Where multiple events described death for the same participant, date of death was taken as per the earliest record.
|
Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Who Switched to Other Therapy Following Etanercept Discontinuation
Time Frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
|
Participants who switched from etanercept to either DMARDs or alternative biologic drug are reported.
|
Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
|
Time on Etanercept Therapy
Time Frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
|
Time on etanercept therapy was calculated by Kaplan-Meier survival analysis.
|
Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
|
Disease Activity Score Based on 28-Joints Count (DAS28) at Baseline
Time Frame: Baseline
|
DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the serological markers of inflammation (erythrocyte sedimentation rate [ESR, millimeter per hour] or C-reactive protein [CRP, milligram per liter]) and patient's general health assessment (recorded on a Visual Analog Scale [VAS] of 0 millimeter [mm]-100 mm).
DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity.
|
Baseline
|
Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Year 1, 2, 3, 4, and 5
Time Frame: Baseline, Year 1, 2, 3, 4, 5
|
DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm).
DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity.
|
Baseline, Year 1, 2, 3, 4, 5
|
Percentage of Participants With Remission and Low Disease Activity as Assessed by Disease Activity Score Based on 28-Joints Count (DAS28)
Time Frame: Year 1, 2, 3, 4, 5
|
DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm).
DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity.
|
Year 1, 2, 3, 4, 5
|
Time to Remission
Time Frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
|
DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm).
DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity.
Time to achieve remission was calculated by Kaplan-Meier survival analysis.
|
Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
|
Health Assessment Questionnaire (HAQ) Score at Baseline
Time Frame: Baseline
|
HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis.
Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities.
HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3.
HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild
functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.
|
Baseline
|
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Year 1, 2, and 3
Time Frame: Baseline, Year 1, 2, 3
|
HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis.
Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities.
HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3.
HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild
functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.
|
Baseline, Year 1, 2, 3
|
Percentage of Participants With Remission Based on Health Assessment Questionnaire (HAQ) Score
Time Frame: Year 1, 2, 3
|
HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis.
Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities.
HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3.
HAQ total scores expressed as overall mean score with range 0-3.
Participants who had HAQ total score <=0.5 were considered in remission state.
|
Year 1, 2, 3
|
Health Assessment Questionnaire (HAQ) Score 6 Months Prior to And 6 Months Post-Switching Etanercept
Time Frame: 6 months prior to and 6 months post switching etanercept
|
HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis.
Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities.
HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3.
HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild
functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.
|
6 months prior to and 6 months post switching etanercept
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
April 12, 2012
First Submitted That Met QC Criteria
July 19, 2012
First Posted (Estimate)
July 20, 2012
Study Record Updates
Last Update Posted (Estimate)
August 5, 2014
Last Update Submitted That Met QC Criteria
July 7, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gastrointestinal Agents
- Etanercept
- Antirheumatic Agents
Other Study ID Numbers
- B1801348
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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