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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

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

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220713
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 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

Exclusion criteria

Exclusion criteria: Had changes to concomitant UC medications since Week 0 of an induction study

Design outcomes

Primary

MeasureTime frame
Efficacy,Safety—

Outcome results

None listed

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