Efficacy of HUMIRA in Subjects With Active Rheumatoid Arthritis - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 13, 2005

Last Updated Date

August 28, 2007

Start Date ^†

August 2004

Current Primary Outcome Measures ^†

Patient reported outcomes, clinical response indicators.

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00234897 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Subject reported assessments of disease activity, physician reported assessments of disease activity, safety parameters, clinical response indicators.

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Efficacy of HUMIRA in Subjects With Active Rheumatoid Arthritis

Official Title ^†

Humira Efficacy Response Optimization Study in Subjects With Active Rheumatoid Arthritis (HERO)

Brief Summary

The purpose of the study is to assess the efficacy of adalimumab in subjects with rheumatoid arthritis focusing on subject-reported outcomes and early response to treatment

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Rheumatoid Arthritis

Intervention ^†

Drug: adalimumab

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

1938

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
Subject, based on assessment of investigator, meets the definition of active RA

Exclusion Criteria:

Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
Female subject who is pregnant or breast-feeding or considering becoming pregnant

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00234897

Responsible Party

Secondary IDs ^††

HERO

Study Sponsor ^†

Abbott

Collaborators ^††

Investigators ^†

Study Director:

Beverly Paperiello

Abbott

Information Provided By

Abbott

Verification Date

August 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.