Trial Outcomes & Findings for Preference for a Prefilled Syringe or Smartject™ Device for Delivering Golimumab in Participants Suffering From Moderate-to-severe Ulcerative Colitis (MK-8259-027) (NCT NCT02155335)
NCT ID: NCT02155335
Last Updated: 2019-03-15
Results Overview
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.
COMPLETED
PHASE4
100 participants
Day 0 (post last injection)
2019-03-15
Participant Flow
Participant milestones
| Measure |
Prefilled Syringe→Smartject™ Device
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 receive a total of 200 mg of golimumbab.
|
Smartject™ Device→ Prefilled Syringe
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 than is 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.
|
|---|---|---|
|
Period 1
STARTED
|
50
|
50
|
|
Period 1
Treated
|
50
|
49
|
|
Period 1
COMPLETED
|
50
|
49
|
|
Period 1
NOT COMPLETED
|
0
|
1
|
|
Period 2
STARTED
|
50
|
49
|
|
Period 2
COMPLETED
|
50
|
49
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preference for a Prefilled Syringe or Smartject™ Device for Delivering Golimumab in Participants Suffering From Moderate-to-severe Ulcerative Colitis (MK-8259-027)
Baseline characteristics by cohort
| Measure |
All Treated Participants
n=99 Participants
All participants who received at least 1 injection from either prefilled syringe or Smartject
|
|---|---|
|
Age, Continuous
|
42.6 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (post last injection)Population: All enrolled participants who met all inclusion and none of the exclusion criteria, received all four injections of golimumab according to the protocol, and completed the device preference questionnaire
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.
Outcome measures
| Measure |
Per Protocl Set (PPS)
n=91 Participants
All enrolled participants who met all inclusion and none of the exclusion criteria, received all four injections of golimumab according to the protocol, and completed the device preference questionnaire.
|
|---|---|
|
Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (Day of Injections)
Preferred Prefilled Syringe
|
20.9 Percentage of Participants
|
|
Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (Day of Injections)
Preferred Smatject Device
|
76.9 Percentage of Participants
|
|
Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (Day of Injections)
Undecided
|
2.2 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 14 (2 weeks post injections)Population: All enrolled participants who met all inclusion and none of the exclusion criteria, received all four injections of golimumab according to the protocol, and completed the device preference questionnaire
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.
Outcome measures
| Measure |
Per Protocl Set (PPS)
n=91 Participants
All enrolled participants who met all inclusion and none of the exclusion criteria, received all four injections of golimumab according to the protocol, and completed the device preference questionnaire.
|
|---|---|
|
Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (2 Weeks Post Injections)
Preferred Prefilled Syringe
|
26.4 Percentage of Participants
|
|
Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (2 Weeks Post Injections)
Preferred Smatject Device
|
71.4 Percentage of Participants
|
|
Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (2 Weeks Post Injections)
Undecided
|
2.2 Percentage of Participants
|
Adverse Events
All Treated Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.
- Publication restrictions are in place
Restriction type: OTHER