A Phase 4 interventional study of Prefilled Syringe delivery of Golimumab and Smartject Device delivery of Golimumab in Ulcerative Colitis, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-15.
Sponsored by Merck Sharp & Dohme LLC · Phase 4, Interventional, and Treatment
This study is designed to determine whether ulcerative colitis participants prefer delivery of golimumab via a prefilled syringe or the Smartject™ device.
1,074 studies on the registry are indexed under Colitis; 133 are open to participants now.
This study's enrollment of 100 is above the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant is then administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab).
Drug: Prefilled Syringe delivery of Golimumab
Golimumab 50 mg supplied in a Smartject administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant is then administered Golimumab 50 mg supplied a prefilled syringe 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab.
Drug: Smartject Device delivery of Golimumab
Golimumab 50 mg solution for subcutaneous injection using prefilled syringe
Golimumab 50 mg solution for subcutaneous injection using Smartject Device.
Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (Day of Injections)
Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant is then administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Following the completion of the last injection, the participants completed a questionnaire in which they indicated if they preferred the syringe, the Smartject or were undecided as to which they preferred.
Time frame: Day 0 (post last injection)
Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (2 Weeks Post Injections)
Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant than is administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Participants completed a questionnaire 2 weeks after the injections in which they indicated if they preferred the syringe, the Smartject or were undecided as to which they preferred.
Time frame: Day 14 (2 weeks post injections)
| Milestone | Prefilled Syringe→Smartject™ Device | Smartject™ Device→ Prefilled Syringe |
|---|---|---|
| Started | 50 | 50 |
| Treated | 50 | 49 |
| Completed | 50 | 49 |
| Not completed | 0 | 1 |
| Milestone | Prefilled Syringe→Smartject™ Device | Smartject™ Device→ Prefilled Syringe |
|---|---|---|
| Started | 50 | 49 |
| Completed | 50 | 49 |
| Not completed | 0 | 0 |
Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant is then administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Following the completion of the last injection, the participants completed a questionnaire in which they indicated if they preferred the syringe, the Smartject or were undecided as to which they preferred.
| Percentage of Participants | Per Protocl Set (PPS) |
|---|---|
| Preferred Prefilled Syringe | 20.9 |
| Preferred Smatject Device | 76.9 |
| Undecided | 2.2 |
Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant than is administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Participants completed a questionnaire 2 weeks after the injections in which they indicated if they preferred the syringe, the Smartject or were undecided as to which they preferred.
| Percentage of Participants | Per Protocl Set (PPS) |
|---|---|
| Preferred Prefilled Syringe | 26.4 |
| Preferred Smatject Device | 71.4 |
| Undecided | 2.2 |
Collected over up to 14 days post injections. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Treated Participants | — | 0/99 (0%) | 0/99 (0%) |
1 enrolled participant withdrew prior to treatment.
| Age, Continuous(years) | All Treated Participants |
|---|---|
| Mean | 42.6 ± 14.4 |
| Sex: Female, Male(Participants) | All Treated Participants |
|---|---|
| Female | 42 |
| Male | 57 |
No study locations are listed for this record.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC