Ulcerative Colitis
Conditions
Brief summary
This study is designed to determine whether ulcerative colitis participants prefer delivery of golimumab via a prefilled syringe or the Smartject™ device.
Interventions
DRUGPrefilled Syringe delivery of Golimumab
Golimumab 50 mg solution for subcutaneous injection using prefilled syringe
DRUGSmartject Device delivery of Golimumab
Golimumab 50 mg solution for subcutaneous injection using Smartject Device.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Anti-tumor necrosis factor (anti-TNF) naive participants with a diagnosis of moderate-to-severe ulcerative colitis. * Mayo clinic score \>= 6, including endoscopic subscore \>=2; * Previous conventional therapy for a period of at least 3 months with aminosalicylates and at least 3 months with corticosteroids or 6-mercaptopurine (6-MP) or azathioprine (AZA), unless the participant is intolerant to, or has contraindications to these treatments; * Anti-TNF experienced participants with an established diagnosis of moderate-to-severe ulcerative colitis, either not responding or partially responding to treatment with Remicade (infliximab). The participant must also meet the following criteria prior to initiating first-line anti-TNF treatment: Mayo score ≥ 6, including an endoscopic subscore ≥ 2; and previous conventional therapy of at least 3 months with aminosalicylates and at least 3 months with corticosteroids or 6-mercaptopurine (6-MP) or azathioprine (AZA), unless the participant is intolerant to or have medical contraindications for such therapies (should be documented); * Sexually active women of child-bearing potential must agree to use a medically accepted method of contraception while receiving study drug and for 6 months after the stop of study drug
Exclusion criteria
* Has a history of prior self-injection for any reason; * Has concomitant use of other biologic agents; * Has active tuberculosis (TB) within 12 months prior to the first injection or has suspected latent TB as indicated by a positive tuberculin skin test. * Has an active clinical non-tuberculous mycobacterial infection or opportunistic infection within 6 months prior to the first injection; * Has had an active infection and/or serious infection within 6 months prior to the first study drug administration; * Has had a live viral or bacterial vaccination within 3 months prior to the first study injection or Bacillus Calmette-Guerin vaccination within 12 months prior to the first study drug injection; * Has evidence of heart failure of New York Heart Association class 3-4; * Has a history of demyelinating disease such as multiple sclerosis or optic neuritis; * Has a history of systemic lupus erythematosus; * Has a history of lymphoproliferative disease, or any unknown malignancy or history of malignancy within the prior 5 years, with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence; * Has had an active hepatitis B infection; * Has an allergy or sensitivity to golimumab or its excipients; * Is pregnant or breast feeding; * Is sensitive to latex.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (Day of Injections) | Day 0 (post last injection) | 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 Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (2 Weeks Post Injections) | Day 14 (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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Treated Participants All participants who received at least 1 injection from either prefilled syringe or Smartject | 99 |
| Total | 99 |
Baseline characteristics
| Characteristic | All Treated Participants |
|---|---|
| Age, Continuous | 42.6 years STANDARD_DEVIATION 14.4 |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 99 |
| serious Total, serious adverse events | 0 / 99 |
Outcome results
Primary
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)
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Per Protocl Set (PPS) | Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (2 Weeks Post Injections) | Preferred Prefilled Syringe | 26.4 Percentage of Participants |
| Per Protocl Set (PPS) | Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (2 Weeks Post Injections) | Preferred Smatject Device | 71.4 Percentage of Participants |
| Per Protocl Set (PPS) | Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (2 Weeks Post Injections) | Undecided | 2.2 Percentage of Participants |
Primary
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)
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Per Protocl Set (PPS) | Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (Day of Injections) | Preferred Prefilled Syringe | 20.9 Percentage of Participants |
| Per Protocl Set (PPS) | Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (Day of Injections) | Undecided | 2.2 Percentage of Participants |
| Per Protocl Set (PPS) | Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (Day of Injections) | Preferred Smatject Device | 76.9 Percentage of Participants |