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

NCT00408629 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 518

Last updated 2011-05-03

Study results available
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Summary

This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of the human anti-tumor necrosis factor (TNF) monoclonal antibody adalimumab (ADA) in patients with moderately to severely active ulcerative colitis (UC).

Conditions

Interventions

BIOLOGICAL

adalimumab

Prefilled syringe, 40 mg, 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week between Weeks 4 and 50.

BIOLOGICAL

placebo

Matching Placebo for prefilled syringe, 40 mg,

Sponsors & Collaborators

Principal Investigators

  • Roopal B Thakkar, M.D. · 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
2010-03-31
Completion
2010-03-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Israel
  • New Zealand
  • Norway
  • Poland
  • Portugal
  • Spain
  • Switzerland

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 NCT00408629 on ClinicalTrials.gov