♦Basic information
JapicCTI-No. JapicCTI-090740
♦Title of the study
Title of the study A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis
Public title of the study
Primary sponsor JANSSEN PHARMACEUTICAL K.K
Secondary sponsor  
Study Type interventional (drug)
Summary To evaluate the safety and efficacy of golimumab maintenance therapy, administered subcutaneously, in subjects with moderately to severely active ulcerative colitis
♦Details of the study
Disease or condition Ulcerative Colitis
Intervention
Intervention name golimumab
Classification name(code) of the intervention 239 (other agents affecting digestive organs)
Dosage And administration of the intervention SC
Control intervention name  
Classification name(code) of the control intervention  
Dosage And administration of the control intervention  
Objectives of the study The purpose of this study is to assess the effects (good and bad) of golimumab therapy in patients with ulcerative colitis
Study phase Phase 3
Study design Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Target sample size
Inclusion Criteria Have received all study agent administrations and completed the Week 6 Mayo score evaluation in one of the induction studies of CNTO 148 (golimumab) for (UC) Ulcerative Colitis

AgeF     18years old or more
SexF     Both
Exclusion Criteria Had changes to concomitant UC medications since Week 0 of an induction study

Outcome
Primary Outcome Efficacy,Safety
Timepoints
Secondary Outcome  
Timepoints  
Institutions
Duration of the study 2008-12-8  `  2014-10-31
Study status Closed
recruitment status Study Completed
Region Japan, USA, Netherlands, Others
♦Secondary ID
Related ID Name Clinical Trials.gov
Related ID number NCT00488631
♦Related information
Name of URL  
URL address  
Description of URL  
♦Contact information
Organization JANSSEN PHARMACEUTICAL K.K
Division Medical Writing Department,Clinical R&D Division
Contact person or e-mail address etc. JP-CTR@its.jnj.com
Organization@(Scientific)
Division@(Scientific)
Contact person or e-mail address etc.@(Scientific)
♦Other
Source funded
Name of research funds
Other
♦History
History
2015/7/10   revised
2013/9/10   revised
2010/11/17   revised
2009/4/10   application date