NCT03193957

Brief Summary

A study comparing the usability of the Autoinjector and Pre-filled Syringe of SB4 in Subjects with Rheumatoid Arthritis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started May 2017

Shorter than P25 for phase_2 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2017

Completed
Last Updated

October 13, 2017

Status Verified

July 1, 2017

Enrollment Period

3 months

First QC Date

June 19, 2017

Last Update Submit

October 12, 2017

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • The change in Injection site pain score at immediately post injection (within 1 minute)

    The change in injection site pain score at immediately post injection (within 1 minute) using an 11-point visual numeric scale

    at Week 1 and Week 3

Study Arms (1)

SB4

EXPERIMENTAL

SB4 (etanercept) 50 mg/mL

Drug: EtanerceptDevice: Autoinjector

Interventions

EtanerceptDRUG

Etanercept PFS and Autoinjector

SB4
AutoinjectorDEVICE

Autoinjector

SB4

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects are male or female aged 18-55 years at the time of signing the informed consent form.

You may not qualify if:

  • Have been treated previously with monoclonal antibody agent including any tumour necrosis factor inhibitor except SB4.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AI Centrum Medyczne

Poznan, Poland

Location

Related Publications (1)

  • Rho YH, Rychlewska-Hanczewska A, Sliwowska B, Kim TH. Usability of Prefilled Syringe and Autoinjector for SB4 (An Etanercept Biosimilar) in Patients with Rheumatoid Arthritis. Adv Ther. 2019 Sep;36(9):2287-2295. doi: 10.1007/s12325-019-01027-z. Epub 2019 Aug 1.

    PMID: 31372961DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2017

First Posted

June 21, 2017

Study Start

May 15, 2017

Primary Completion

August 3, 2017

Study Completion

September 25, 2017

Last Updated

October 13, 2017

Record last verified: 2017-07

Locations

PL(1)