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A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis

A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220712
Enrollment
Unknown
Registered
2009-04-10
Start date
2009-04-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Interventions

investigational material(s) Generic name etc : golimumab INN of investigational material : Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration for Invest

Sponsors

JANSSEN PHARMACEUTICAL K.K
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Have a biopsy consistent with the diagnosis of moderately to severely active ulcerative colitis (UC) prior to the beginning of the trial Must either be currently receiving treatment with, or have a history of having failed to respond to, or tolerate, at least 1 of the following therapies: oral 5-ASAs, oral corticosteroids, 6-mercaptopurine(6MP) and azathioprine (AZA ) Have or have had a history of corticosteroid dependency (i.e. an inability to successfully taper corticosteroids without a return of the symptoms of UC)

Exclusion criteria

Exclusion criteria: Have severe extensive ulcerative colitis that is likely to require a colectomy within 12 weeks of study entry Have UC limited to the rectum only or to < 20 cm of the colon Presence of a stoma Presence or history of a fistula Previous exposure to anti-TNF therapies

Design outcomes

Primary

MeasureTime frame
Efficacy,Safety—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026