Study to Evaluate the Safety and Efficacy of Two Drug Regimens in Subjects with Moderate to Severe Ulcerative Colitis

A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis [M14-033]

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222597

Enrollment

100

Registered

2014-09-03

Start date

2014-07-22

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 : adalimumab INN of investigational material : adalimumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Diagnosis of Ulcerative Colitis (UC) for at least 90 days, confirmed by endoscopy with biopsy during Screening period. 2.Active UC with Mayo Score of 6 to 12 points and endoscopy subscore of 2 to 3 despite concurrent treatment with oral corticosteroids or immunosuppressants or both.

Exclusion criteria

Exclusion criteria: 1.Subject with Crohn's disease (CD) or indeterminate colitis (IC). 2.Current diagnosis of fulminant colitis and/or toxic megacolon. 3.Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy. 4.Chronic recurring infections or active Tuberculosis (TB).

Design outcomes

Primary

Measure	Time frame
efficacy Proportion of subjects achieving clinical remission (per full Mayo Score) [ Time Frame: Week 8 ] Proportion of Week 8 responders (per full Mayo Score) achieving clinical remission (per full Mayo Score) [ Time Frame: Week 52 ]	—

Secondary

Measure	Time frame
efficacy Proportion of subjects achieving endoscopic improvement (endoscopic subscore of 0 or 1) [ Time Frame: Week 8 ] Proportion of Week 8 responders (per full Mayo Score) achieving endoscopic improvement (endoscopic subscore of 0 or 1) [ Time Frame: Week 52 ]	—

Countries

Europe, Japan, North America

Outcome results

None listed

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