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
A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid 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 →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.
Exclusion Criteria:
Have any of the following conditions:
Drug: Adalimumab PFS and Pen
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)
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
Subject Preference of SC Delivery Administration of SB5 Using Questionnaire
Time frame: at Week 6
| Milestone | SB5 40mg |
|---|---|
| Started | 49 |
| Completed | 48 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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.
| 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) |
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.
| Participants | Week 2 (SB5 40 mg PFS) | Week 6 (SB5 40 mg Pen) |
|---|---|---|
| Extremely Favorable | 1 | 3 |
| Favorable | 13 | 15 |
| Neutral | 31 | 21 |
| Unfavorable | 3 | 7 |
| Extremely Unfavorable | 0 | 0 |
| number of responders | SB5 PFS | SB5 Pen | No Preference |
|---|---|---|---|
| Overall Preference | 14 | 26 | 6 |
| Category: Ease of Use | 10 | 33 | 3 |
| Category: Convenience | 6 | 35 | 5 |
| Category: Time to Administer Injection | 9 | 30 | 7 |
| Category: Safety | 6 | 31 | 9 |
| Category: Less Pain | 17 | 21 | 8 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SB5 40mg | 0/49 (0%) | 0/49 (0%) | 4/49 (8.2%) |
| Event | SB5 40mg |
|---|---|
| NasopharyngitisInfections and infestations | 4/49 |
| Age, Continuous(years) | SB5 40mg |
|---|---|
| Mean | 40.9 ± 9.08 |
| Sex: Female, Male(Participants) | SB5 40mg |
|---|---|
| Female | 39 |
| Male | 10 |
| Ethnicity (NIH/OMB)(Participants) | SB5 40mg |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 49 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | SB5 40mg |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 49 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Height (cm)(cm) | SB5 40mg |
|---|---|
| Mean | 167.69 ± 8.799 |
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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Samsung Bioepis Co., Ltd.