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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01646385
First received: April 12, 2012
Last updated: August 28, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: etanercept
Drug: non-biologic anti-rheumatic drugs
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:

Drug Information available for: Etanercept
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of participants reporting serious adverse events [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disease Activity Score Based on 28-joints Count (DAS28) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire (HAQ) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Proportion of participants discontinuing therapy [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: February 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
etanercept
adult rheumatoid arthritis patients initiating therapy with etanercept as their first biologic therapy
 Drug: etanercept
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).
 Drug: non-biologic anti-rheumatic drugs
use as per routine clinical practice (methotrexate, azathioprine, cyclophosphamide, cyclosporine, leflunomide, other)

Detailed Description:

patients recruited sequentially as seen in clinical practice

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

adult patients with a diagnosis of rheumatoid arthritis

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646385

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01646385     History of Changes
Other Study ID Numbers: B1801348
Study First Received: April 12, 2012
Last Updated: August 28, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Pfizer:
observational
non-interventional
cohort
 retrospective
register
rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013