Trial Outcomes & Findings for 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 (NCT NCT02565810)

Last Updated: 2019-04-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

49 participants

Primary outcome timeframe

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

Results posted on

2019-04-01

Participant Flow

Participant milestones

Participant milestones
Measure	SB5 40mg Adalimumab PFS and Pen
Overall Study STARTED	49
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	SB5 40mg Adalimumab PFS and Pen
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SB5 40mg n=49 Participants Adalimumab PFS and Pen
Age, Continuous	40.9 years STANDARD_DEVIATION 9.08 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Height (cm)	167.69 cm STANDARD_DEVIATION 8.799 • n=5 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	SB5 Pen/PFS n=49 Participants Injection via PFS at Week 0 and Week 2 and then injection via Pen st Week 4 and then every other week thereafter up to Week 10	Week 6 (SB5 40 mg Pen) 40 mg sc injection via PFS at Week 0 and Week 2 and then 40 mg sc injection via Pen st Week 4 and then every other week thereafter up to Week 10.	No Preference Subject who chose 'no preference' at Week 6
The Change in Injection Site Pain Score Using an 11-point Visual Numeric Scale Immediately post-injection	-0.35 Difference (scores on a scale) Interval -0.99 to 0.3	—	—
The Change in Injection Site Pain Score Using an 11-point Visual Numeric Scale 15-30 min post-injection	-0.11 Difference (scores on a scale) Interval -0.47 to 0.25	—	—

SECONDARY outcome

Timeframe: at Week 2 and at Week 6

Population: Only number of subjects with available assessment results at each visit were counted as 'Overall number of participants analyzed'.

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.

Outcome measures

Outcome measures
Measure	SB5 Pen/PFS n=48 Participants Injection via PFS at Week 0 and Week 2 and then injection via Pen st Week 4 and then every other week thereafter up to Week 10	Week 6 (SB5 40 mg Pen) n=46 Participants 40 mg sc injection via PFS at Week 0 and Week 2 and then 40 mg sc injection via Pen st Week 4 and then every other week thereafter up to Week 10.	No Preference Subject who chose 'no preference' at Week 6
Overall Impression of SC Delivery Administration of SB5 Using Questionnaire Extremely Favorable	1 Participants	3 Participants	—
Overall Impression of SC Delivery Administration of SB5 Using Questionnaire Favorable	13 Participants	15 Participants	—
Overall Impression of SC Delivery Administration of SB5 Using Questionnaire Neutral	31 Participants	21 Participants	—
Overall Impression of SC Delivery Administration of SB5 Using Questionnaire Unfavorable	3 Participants	7 Participants	—
Overall Impression of SC Delivery Administration of SB5 Using Questionnaire Extremely Unfavorable	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: at Week 6

Population: Overall number of participants analyzed means number of subjects with available assessment results

Outcome measures

Outcome measures
Measure	SB5 Pen/PFS n=46 Participants Injection via PFS at Week 0 and Week 2 and then injection via Pen st Week 4 and then every other week thereafter up to Week 10	Week 6 (SB5 40 mg Pen) n=46 Participants 40 mg sc injection via PFS at Week 0 and Week 2 and then 40 mg sc injection via Pen st Week 4 and then every other week thereafter up to Week 10.	No Preference n=46 Participants Subject who chose 'no preference' at Week 6
Subject Preference of SC Delivery Administration of SB5 Using Questionnaire Category: Convenience	6 number of responders	35 number of responders	5 number of responders
Subject Preference of SC Delivery Administration of SB5 Using Questionnaire Overall Preference	14 number of responders	26 number of responders	6 number of responders
Subject Preference of SC Delivery Administration of SB5 Using Questionnaire Category: Ease of Use	10 number of responders	33 number of responders	3 number of responders
Subject Preference of SC Delivery Administration of SB5 Using Questionnaire Category: Time to Administer Injection	9 number of responders	30 number of responders	7 number of responders
Subject Preference of SC Delivery Administration of SB5 Using Questionnaire Category: Safety	6 number of responders	31 number of responders	9 number of responders
Subject Preference of SC Delivery Administration of SB5 Using Questionnaire Category: Less Pain	17 number of responders	21 number of responders	8 number of responders

Adverse Events

SB5 40mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SB5 40mg n=49 participants at risk Adalimumab PFS and Pen
Infections and infestations Nasopharyngitis	8.2% 4/49 • Number of events 4

Additional Information

Director of Clinical Trials

Samsung Bioepis Co., Ltd.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place