NCT02565810

Brief Summary

A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at below P25 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_2 rheumatoid-arthritis

Geographic Reach
1 country

2 active sites

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

September 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

April 1, 2019

Completed
Last Updated

April 1, 2019

Status Verified

December 1, 2018

Enrollment Period

6 months

First QC Date

September 23, 2015

Results QC Date

May 14, 2018

Last Update Submit

December 30, 2018

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • The Change in Injection Site Pain Score Using an 11-point Visual Numeric Scale

    Injection site pain evaluation questionnaire will be rated on an 11-point numeric rating scale ranging from 0 (no pain) to 10 (pain as bad as it could be) at two-time points post-injection (immediately post-injection and between 15 to 30 minutes post-injection) at Weeks 0, 2, 4, and 6.

    Difference of injection site pain score (Week 6 - Week 2)

Secondary Outcomes (2)

  • Overall Impression of SC Delivery Administration of SB5 Using Questionnaire

    at Week 2 and at Week 6

  • Subject Preference of SC Delivery Administration of SB5 Using Questionnaire

    at Week 6

Study Arms (1)

SB5 40mg

EXPERIMENTAL
Drug: Adalimumab PFS and Pen

Interventions

Adalimumab PFS and PenDRUG
SB5 40mg

Eligibility Criteria

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

You may qualify if:

  • Are male or female aged 18-55 years at the time of signing the informed consent form.
  • Have been diagnosed as having RA according to the revised 1987 American College of Rheumatology (ACR) criteria for at least 6 months prior to Screening.
  • Subjects who are considered by the Investigator to be a suitable candidate for self-administering adalimumab treatment
  • Must be able to provide informed consent, which must be obtained prior to any study related procedures.

You may not qualify if:

  • Have been treated previously with any biologic agents including any tumour necrosis factor inhibitor.
  • Have a known hypersensitivity to human immunoglobulin proteins or other components of SB5.
  • Have a current diagnosis of active tuberculosis (TB), have been recently exposed to a person with active TB, or are considered to have latent TB indicated by a positive QuantiFERON® Gold test result.
  • Have a history of chronic or recurrent infection (such as chronic renal infection, chronic chest infection or recurrent urinary infection).
  • Have any of the following conditions:
  • History of congestive heart failure (New York Heart Association Class III/IV)
  • History of demyelinating disorders (such as multiple sclerosis or Guillain-Barré syndrome).
  • History of lymphoproliferative disease including lymphoma or melanoma.
  • Any other disease or disorder which, in the opinion of the Investigator, will put the subject at risk if they are enrolled.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medica Pro Familia Sp. z o.o. S.K.A. Oddzial Gdynia

Gdynia, Poland

Location

Medica pro Familia Sp z o.o. S.K.A Oddzial Warszawa

Warsaw, Poland

Location

Related Publications (1)

  • Ghil J, Zielinska A, Lee Y. Usability and safety of SB5 (an adalimumab biosimilar) prefilled syringe and autoinjector in patients with rheumatoid arthritis. Curr Med Res Opin. 2019 Mar;35(3):497-502. doi: 10.1080/03007995.2018.1560211. Epub 2019 Jan 17.

    PMID: 30561229DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

penclomedine

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Director of Clinical Trials
Organization
Samsung Bioepis Co., Ltd.
sbregistry@samsung.com

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

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

September 23, 2015

First Posted

October 1, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 1, 2019

Results First Posted

April 1, 2019

Record last verified: 2018-12

Locations

PL(2)