Rheumatoid Arthritis
Conditions
Brief summary
A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis.
Interventions
DRUGAdalimumab PFS and Pen
Sponsors
Samsung Bioepis Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Poland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SB5 40mg Adalimumab PFS and Pen | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | SB5 40mg |
|---|---|
| Age, Continuous | 40.9 years STANDARD_DEVIATION 9.08 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height (cm) | 167.69 cm STANDARD_DEVIATION 8.799 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 49 Participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 49 |
| other Total, other adverse events | 4 / 49 |
| serious Total, serious adverse events | 0 / 49 |
Outcome results
Primary
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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SB5 Pen/PFS | The Change in Injection Site Pain Score Using an 11-point Visual Numeric Scale | Immediately post-injection | -0.35 Difference (scores on a scale) |
| SB5 Pen/PFS | 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) |
Secondary
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
Population: Only number of subjects with available assessment results at each visit were counted as 'Overall number of participants analyzed'.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB5 Pen/PFS | Overall Impression of SC Delivery Administration of SB5 Using Questionnaire | Favorable | 13 Participants |
| SB5 Pen/PFS | Overall Impression of SC Delivery Administration of SB5 Using Questionnaire | Unfavorable | 3 Participants |
| SB5 Pen/PFS | Overall Impression of SC Delivery Administration of SB5 Using Questionnaire | Neutral | 31 Participants |
| SB5 Pen/PFS | Overall Impression of SC Delivery Administration of SB5 Using Questionnaire | Extremely Unfavorable | 0 Participants |
| SB5 Pen/PFS | Overall Impression of SC Delivery Administration of SB5 Using Questionnaire | Extremely Favorable | 1 Participants |
| Week 6 (SB5 40 mg Pen) | Overall Impression of SC Delivery Administration of SB5 Using Questionnaire | Extremely Unfavorable | 0 Participants |
| Week 6 (SB5 40 mg Pen) | Overall Impression of SC Delivery Administration of SB5 Using Questionnaire | Extremely Favorable | 3 Participants |
| Week 6 (SB5 40 mg Pen) | Overall Impression of SC Delivery Administration of SB5 Using Questionnaire | Favorable | 15 Participants |
| Week 6 (SB5 40 mg Pen) | Overall Impression of SC Delivery Administration of SB5 Using Questionnaire | Neutral | 21 Participants |
| Week 6 (SB5 40 mg Pen) | Overall Impression of SC Delivery Administration of SB5 Using Questionnaire | Unfavorable | 7 Participants |
Secondary
Subject Preference of SC Delivery Administration of SB5 Using Questionnaire
Time frame: at Week 6
Population: Overall number of participants analyzed means number of subjects with available assessment results
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SB5 Pen/PFS | Subject Preference of SC Delivery Administration of SB5 Using Questionnaire | Overall Preference | 14 number of responders |
| SB5 Pen/PFS | Subject Preference of SC Delivery Administration of SB5 Using Questionnaire | Category: Ease of Use | 10 number of responders |
| SB5 Pen/PFS | Subject Preference of SC Delivery Administration of SB5 Using Questionnaire | Category: Convenience | 6 number of responders |
| SB5 Pen/PFS | Subject Preference of SC Delivery Administration of SB5 Using Questionnaire | Category: Time to Administer Injection | 9 number of responders |
| SB5 Pen/PFS | Subject Preference of SC Delivery Administration of SB5 Using Questionnaire | Category: Safety | 6 number of responders |
| SB5 Pen/PFS | Subject Preference of SC Delivery Administration of SB5 Using Questionnaire | Category: Less Pain | 17 number of responders |
| Week 6 (SB5 40 mg Pen) | Subject Preference of SC Delivery Administration of SB5 Using Questionnaire | Category: Less Pain | 21 number of responders |
| Week 6 (SB5 40 mg Pen) | Subject Preference of SC Delivery Administration of SB5 Using Questionnaire | Overall Preference | 26 number of responders |
| Week 6 (SB5 40 mg Pen) | Subject Preference of SC Delivery Administration of SB5 Using Questionnaire | Category: Time to Administer Injection | 30 number of responders |
| Week 6 (SB5 40 mg Pen) | Subject Preference of SC Delivery Administration of SB5 Using Questionnaire | Category: Safety | 31 number of responders |
| Week 6 (SB5 40 mg Pen) | Subject Preference of SC Delivery Administration of SB5 Using Questionnaire | Category: Ease of Use | 33 number of responders |
| Week 6 (SB5 40 mg Pen) | Subject Preference of SC Delivery Administration of SB5 Using Questionnaire | Category: Convenience | 35 number of responders |
| No Preference | Subject Preference of SC Delivery Administration of SB5 Using Questionnaire | Category: Ease of Use | 3 number of responders |
| No Preference | Subject Preference of SC Delivery Administration of SB5 Using Questionnaire | Category: Convenience | 5 number of responders |
| No Preference | Subject Preference of SC Delivery Administration of SB5 Using Questionnaire | Category: Less Pain | 8 number of responders |
| No Preference | Subject Preference of SC Delivery Administration of SB5 Using Questionnaire | Category: Time to Administer Injection | 7 number of responders |
| No Preference | Subject Preference of SC Delivery Administration of SB5 Using Questionnaire | Overall Preference | 6 number of responders |
| No Preference | Subject Preference of SC Delivery Administration of SB5 Using Questionnaire | Category: Safety | 9 number of responders |