Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From Enbrel

NCT03100734 | Completed FDA Drug

• 1 other identifier: EUR-BNP-16-11030
• Study Type: observational
• Target: 585
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to evaluate the effectiveness of Benepali in participants with Rheumatoid Arthritis (RA) and axial spondyloarthritis (axSpA), including participants with Ankylosing Spondylitis (AS) and non-radiographic axSpA, following their transition from treatment with Enbrel. The secondary objectives of this study are to describe clinical characteristics of patients transitioned from Enbrel® to Benepali® in routine practice, to evaluate safety during and following the transition from Enbrel to Benepali and to evaluate patient-reported outcomes during and following the transition from Enbrel to Benepali.

Conditions

Rheumatoid Arthritis; Axial Spondyloarthritis

Keywords

Observational; Biosimilar; Etanercept; Benepali; Enbrel

Outcome Measures

Primary Outcomes (2)

• Change from transition point in Disease Activity Score (DAS-28 score)

  Score of 28 joints examined

  Approximately 3 months after the transition

• Change from transition point in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score

  Mean BASDAI score

  Approximately 3 months after the transition

Secondary Outcomes (20)

• Change in the DAS-28 score over time from the value obtained at the Transition Point

  Approximately 3 and 6 months after the transition

• Proportion of participants with low disease activity or remission over time following Transition Point

  Approximately 3 and 6 months after the transition

• Proportion of participants with worsening disease over time following Transition Point

  Approximately 3 and 6 months after the transition

• Proportion of participants with an improvement of ≥ 1.2 points in DAS-28 score from Transition Point

  Approximately 3 and 6 months after the transition

• Change in the General Health Score (assessed using VAS) over time following transition point

  Approximately 3 and 6 months after the transition

Study Arms (2)

With RA

Participants with RA previously treated with Enbrel and transitioned to Benepali

Biological: Benepali; Biological: Enbrel

With axSpA

Participants with axSpA previously treated with Enbrel and transitioned to Benepali

Biological: Benepali; Biological: Enbrel

Interventions

Benepali BIOLOGICAL

As specified in the treatment arm

With RA; With axSpA

Enbrel BIOLOGICAL

As specified in the treatment arm

Also known as: etanercept

With RA; With axSpA

Eligibility Criteria

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

Study Population

Participants With Rheumatoid Arthritis or Axial Spondyloarthritis to be identified from Primary Care Practice / Hospital

You may qualify if:

• Must have been diagnosed with either rheumatoid arthritis or axial spondyloarthritis, according to local practice
• Transition from Enbrel to Benepali at the physician's (Investigator's) discretion prior to enrolment into the study
• Must have been treated with the same dose of Enbrel for at least 6 months prior to transition to Benepali and have at least 1 efficacy data value including but not restricted to DAS-28 or BASDAI during that period
• Must have a stable disease throughout the 2 month prior to enrolment based on the Investigator's judgement
• Women of childbearing potential should be advised to use appropriate contraception to avoid becoming pregnant during Benepali therapy and for three weeks after discontinuation of therapy

You may not qualify if:

• Have any medical conditions that precludes administration of Benepali according to Summary of Product Characteristics (SmPC), such as the following:
• Hypersensitivity to the Benepali active substance, or to any of the associated excipients
• Sepsis, or risk of sepsis
• Active clinically significant local or chronic viral, bacterial or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 2 months prior to enrollment
• Show any clinical sign or medical condition not allowing for treatment continuation (of etanercept) in the judgment of the Investigator
• Treatment with another biologic agent
• Are currently receiving or have previously received any therapies that would preclude administration of Benepali, such as the following:
• Immunizations with live or live-attenuated vaccines within the last 6 months prior to transition point and throughout the observation period
• Treatment with investigational agents within the last 6 months prior to transition point and during the period of observation.
• Any other unspecified reasons that would, in the opinion of the Investigator, make the patient unsuitable for enrollment.

Sponsors & Collaborators

• Biogen: lead
• Samsung Bioepis Co., Ltd.: collaborator

Study Sites (1)

Research Site

München, Bavaria, 80639, Germany

Location

Related Links

• Manuscript description

MeSH Terms

Conditions

Arthritis, Rheumatoid; Axial Spondyloarthritis

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; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis

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

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 4, 2017
• Study Start: June 1, 2017
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: February 5, 2021

Record last verified: 2021-02

Locations

DE (1)