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Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Acute Ulcerative Colitis

NCT00385736 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 576

Last updated 2011-04-11

Study results available
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Summary

The objective of this study is to assess the efficacy and safety of adalimumab for the induction of clinical remission in subjects with moderately to severely active ulcerative colitis.

Conditions

Interventions

BIOLOGICAL

adalimumab

Prefilled syringe, 40 mg (loading dose then every other week dosing). 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.

BIOLOGICAL

adalimumab

Prefilled syringe, 40 mg (loading dose then every other week dosing). 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.

BIOLOGICAL

placebo

Placebo for 40 mg syringe. Matching placebo for loading dose and every other week dosing. Subjects received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab eow thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).

Sponsors & Collaborators

Principal Investigators

  • Roopal Thakkar, MD · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2009-04-30
Completion
2010-03-31

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Puerto Rico
  • Slovakia
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00385736 on ClinicalTrials.gov