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Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing

NCT00647270 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2011-04-11

Study results available
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Summary

To demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo and demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adalimumab every other week.

Conditions

Interventions

DRUG

adalimumab

Pre-filled syringe. See arm for more detail

DRUG

Placebo

Pre-filled syringe. See arm for more detail

DRUG

adalimumab

Pre-filled syringe. See arm for more detail

Sponsors & Collaborators

Principal Investigators

  • Laura Redden, 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
2007-12-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Puerto Rico
  • United Kingdom

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 NCT00647270 on ClinicalTrials.gov