Efficacy of HUMIRA in Subjects With Active Rheumatoid Arthritis - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00234897

Purpose

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

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: adalimumab	Phase IV

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Adalimumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Humira Efficacy Response Optimization Study in Subjects With Active Rheumatoid Arthritis (HERO)

Further study details as provided by Abbott:

Primary Outcome Measures:

Patient reported outcomes, clinical response indicators.

Secondary Outcome Measures:

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

Enrollment:	1938
Study Start Date:	August 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234897

Locations

United States, Illinois
Global Medical Information - Abbott
North Chicago, Illinois, United States, 60064

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Beverly Paperiello

Abbott

More Information

Study ID Numbers:	M04-684, HERO
Study First Received:	September 13, 2005
Last Updated:	August 28, 2007
ClinicalTrials.gov Identifier:	NCT00234897
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

adalimumab
rheumatoid arthritis

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Adalimumab

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immune System Diseases
Therapeutic Uses
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009