Conditions: Ulcerative Colitis
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 100
Healthy volunteers: no

Brief summary:
This study is designed to determine whether ulcerative colitis participants prefer delivery of golimumab via a prefilled syringe or the Smartject™ device.

Detailed description:

Arms:
arm 1: 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). arm 2: 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.

Interventions: intervention 1: Prefilled Syringe delivery of Golimumab intervention 2: Smartject Device delivery of Golimumab
Intervention descriptions: intervention 1: Golimumab 50 mg solution for subcutaneous injection using prefilled syringe intervention 2: Golimumab 50 mg solution for subcutaneous injection using Smartject Device.

Protocol document: