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

NCT01646385 | Completed Results

• 1 other identifier: B1801348
• Study Type: observational
• Target: 6,393
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis

Keywords

observational; non-interventional; cohort; retrospective; register; rheumatoid arthritis

Outcome Measures

Primary Outcomes (5)

• Crude Incidence Rate of Malignancy

  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)

  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

  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

  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

  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 Outcomes (10)

• Percentage of Participants Who Switched to Other Therapy Following Etanercept Discontinuation

  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

  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

  Baseline

• Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Year 1, 2, 3, 4, and 5

  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)

  Year 1, 2, 3, 4, 5

Study Arms (2)

etanercept

adult rheumatoid arthritis patients initiating therapy with etanercept as their first biologic therapy

Drug: etanercept

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

Interventions

etanercept DRUG

use as per routine clinical practice

etanercept

non-biologic anti-rheumatic drugs DRUG

use as per routine clinical practice (methotrexate, azathioprine, cyclophosphamide, cyclosporine, leflunomide, other)

nbDMARD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients with a diagnosis of rheumatoid arthritis

You may qualify if:

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

You may not qualify if:

• diagnosis of other inflammatory arthritis

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: July 20, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 5, 2014
• Results First Posted: August 5, 2014

Record last verified: 2014-07