A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis.

PHASE3CompletedINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

March 15, 2013

Primary Completion Date

January 29, 2016

Study Completion Date

January 29, 2016

Conditions
Colitis, Ulcerative
Interventions
DRUG

Golimumab

Participants will receive 200 mg golimumab at Week 0 and 100 mg golimumab at Week 2 as a subcutaneous (SC) (under the skin) injection in the induction phase. Participants who have a clinical response in the induction phase and are randomly allocated to golimumab in the maintenance phase will receive 100 mg SC every 4 weeks through Week 52. Participants who do not have a clinical response in the induction phase will receive 100 mg of golimumab SC at Week 4 and will continue with 100 mg of golimumab SC every 4 weeks through Week 52 only if a response is obtained by Week 8.

OTHER

Placebo

Participants who have a clinical response to golimumab in the induction phase and are randomly allocated to placebo in the maintenance phase will receive SC placebo every 4 weeks through Week 52. However, participants receiving placebo and who will lose clinical response any time during the study will be eligible to receive 100 mg golimumab SC every 4 weeks through Week 52.

Trial Locations (38)

Unknown

Abiko

Chiba

Chikushinoshi

Fujiidera

Fukuoka

Fushimi

Hamamatsu

Hirosaki

Hiroshima

Ikeda

Izumiōtsu

Izumo

Kagoshima

Kahoku

Kanazawa

Kochi

Kurume

Maebashi

Miyazaki

Nagasaki

Nagoya

Nishinomiya

Osaka

Ōita

Saga

Sakura

Sapporo

Sendai

Suita

Sunto

Tokushima

Tokyo

Toyota

Tsu

Tsukuba

Wakayama

Yokkaichi

Yokohama

Sponsors
All Listed Sponsors
lead

Janssen Pharmaceutical K.K.

INDUSTRY