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CompletedNCT02565810Updated Apr 1, 2019Results posted

An Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects With Rheumatoid Arthritis

A Phase 2 interventional study of Adalimumab PFS and Pen in Rheumatoid Arthritis, sponsored by Samsung Bioepis Co., Ltd.. Completed at 2 sites in Poland. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-04-01.

Sponsored by Samsung Bioepis Co., Ltd. · Phase 2, Interventional, and Other

Phase
Phase 2
Study type
Interventional
Enrollment
49
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

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Conditions studied

  • Rheumatoid Arthritis
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 49 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Samsung Bioepis Co., Ltd. is the lead sponsor of 33 studies on the registry; 2 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Are male or female aged 18-55 years at the time of signing the informed consent form.
  2. 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.
  3. Subjects who are considered by the Investigator to be a suitable candidate for self-administering adalimumab treatment
  4. Must be able to provide informed consent, which must be obtained prior to any study related procedures.

Exclusion criteria

Exclusion Criteria:

  1. Have been treated previously with any biologic agents including any tumour necrosis factor inhibitor.
  2. Have a known hypersensitivity to human immunoglobulin proteins or other components of SB5.
  3. 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.
  4. Have had a serious infection (such as sepsis, abscess, opportunistic infections or invasive fungal infection including histoplasmosis) or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to first dose of IP. Nonsignificant infections do not need to be considered exclusionary at the discretion of the Investigator.
  5. Have a history of chronic or recurrent infection (such as chronic renal infection, chronic chest infection or recurrent urinary infection).
  6. Have any of the following conditions:

    1. History of congestive heart failure (New York Heart Association Class III/IV)
    2. History of demyelinating disorders (such as multiple sclerosis or Guillain-Barré syndrome).
    3. History of any malignancy (other than lymphoproliferative disease and melanoma, see Exclusion Criteria 10.f) within the previous 5 years prior to Screening except completely excised and cured squamous carcinoma of the uterine cervix, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma.
    4. History of lymphoproliferative disease including lymphoma or melanoma.
    5. Any other disease or disorder which, in the opinion of the Investigator, will put the subject at risk if they are enrolled.
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Study design

Phase
Phase 2
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    SB5 40mg

    Drug: Adalimumab PFS and Pen

Interventions

  • DrugAdalimumab PFS and Pen
06

What researchers measure

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.

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

Secondary outcomes

  1. Overall Impression of SC Delivery Administration of SB5 Using Questionnaire

    Objective: To evaluate whether overall impressions of SC administrations at Week 2 and Week 6 were comparable between the SC administrations of SB5 via the Pen and via the PFS.

    Time frame: at Week 2 and at Week 6

  2. Subject Preference of SC Delivery Administration of SB5 Using Questionnaire

    Time frame: at Week 6

07

Results

Posted Apr 1, 2019

Participant flow

Participant flow — Overall Study
MilestoneSB5 40mg
Started49
Completed48
Not completed1
Withdrew: Withdrawal by subject1

Outcome measures

PrimaryThe 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.

Time frame:
Difference of injection site pain score (Week 6 - Week 2)
Reported as:
Number · Difference (scores on a scale)
The Change in Injection Site Pain Score Using an 11-point Visual Numeric Scale
Difference (scores on a scale)SB5 Pen/PFS
Immediately post-injection-0.35 (-0.99 to 0.30)
15-30 min post-injection-0.11 (-0.47 to 0.25)
SecondaryOverall Impression of SC Delivery Administration of SB5 Using Questionnaire

Objective: To evaluate whether overall impressions of SC administrations at Week 2 and Week 6 were comparable between the SC administrations of SB5 via the Pen and via the PFS.

Time frame:
at Week 2 and at Week 6
Reported as:
Count of participants · Participants
Overall Impression of SC Delivery Administration of SB5 Using Questionnaire
ParticipantsWeek 2 (SB5 40 mg PFS)Week 6 (SB5 40 mg Pen)
Extremely Favorable13
Favorable1315
Neutral3121
Unfavorable37
Extremely Unfavorable00
SecondarySubject Preference of SC Delivery Administration of SB5 Using Questionnaire
Time frame:
at Week 6
Reported as:
Number · number of responders
Subject Preference of SC Delivery Administration of SB5 Using Questionnaire
number of respondersSB5 PFSSB5 PenNo Preference
Overall Preference14266
Category: Ease of Use10333
Category: Convenience6355
Category: Time to Administer Injection9307
Category: Safety6319
Category: Less Pain17218

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SB5 40mg0/49 (0%)0/49 (0%)4/49 (8.2%)
Most frequent other events
Most frequent other events
EventSB5 40mg
NasopharyngitisInfections and infestations4/49

Baseline characteristics

Age, Continuous
Age, Continuous(years)SB5 40mg
Mean40.9 ± 9.08
Sex: Female, Male
Sex: Female, Male(Participants)SB5 40mg
Female39
Male10
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SB5 40mg
Hispanic or Latino0
Not Hispanic or Latino49
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SB5 40mg
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White49
More than one race0
Unknown or Not Reported0
Height (cm)
Height (cm)(cm)SB5 40mg
Mean167.69 ± 8.799
08

Study locations

2 sites
  • Medica Pro Familia Sp. z o.o. S.K.A. Oddzial Gdynia
    Gdynia, Poland
  • Medica pro Familia Sp z o.o. S.K.A Oddzial Warszawa
    Warszawa, Poland
09

References and documents

Publications

  • 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. PubMed 30561229 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02565810
Lead sponsor
Samsung Bioepis Co., Ltd.
Responsible party
Sponsor
First posted
Oct 1, 2015
Start date
Sep 2015
Primary completion
Mar 2016
Completion
Mar 2016
Results posted
Apr 1, 2019
Last update
Apr 1, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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