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

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Adalimumab PFS and Pen

• Registration Number: NCT02565810
• Lead Sponsor: Samsung Bioepis Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-23
• Study First Submitted QC: 2015-09-29
• Study First Posted: 2015-10-01
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2018-05-14
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-30
• Last Update Submitted: 2018-12-30
• Results First Posted: 2019-04-01
• Last Update Posted: 2019-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SB5 40mg	Adalimumab PFS and Pen	-

Primary Outcome Measures

Name	Time	Method
The Change in Injection Site Pain Score Using an 11-point Visual Numeric Scale	Difference of injection site pain score (Week 6 - Week 2)	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.

Secondary Outcome Measures

Name	Time	Method
Overall Impression of SC Delivery Administration of SB5 Using Questionnaire	at Week 2 and at Week 6	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.
Subject Preference of SC Delivery Administration of SB5 Using Questionnaire	at Week 6

Trial Locations

Locations (2)

Medica pro Familia Sp z o.o. S.K.A Oddzial Warszawa; 🇵🇱 Warszawa, Poland

Medica Pro Familia Sp. z o.o. S.K.A. Oddzial Gdynia; 🇵🇱 Gdynia, Poland