Clinical trial NCT02565810: 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
Official title: An Open-labelled, Single-arm, 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Samsung Bioepis Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-10-01
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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:

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.

Primary outcomes:
measure: The Change in Injection Site Pain Score Using an 11-point Visual Numeric Scale
timeFrame: Difference of injection site pain score (Week 6 - Week 2)
Secondary outcomes:
measure: Overall Impression of SC Delivery Administration of SB5 Using Questionnaire
timeFrame: at Week 2 and at Week 6
measure: Subject Preference of SC Delivery Administration of SB5 Using Questionnaire
timeFrame: at Week 6
Other outcomes:
Locations:
city: Gdynia
country: Poland
facility: Medica Pro Familia Sp. z o.o. S.K.A. Oddzial Gdynia
city: Warszawa
country: Poland
facility: Medica pro Familia Sp z o.o. S.K.A Oddzial Warszawa
Study officials:
References:
citation: 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.