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Efficacy of HUMIRA in Subjects With Active Rheumatoid Arthritis (HERO)

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00234897
First received: September 13, 2005
Last updated: August 28, 2007
Last verified: August 2007
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Humira Efficacy Response Optimization Study in Subjects With Active Rheumatoid Arthritis (HERO)

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

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

No publications provided

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

Keywords provided by Abbott:
adalimumab
rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
 Immune System Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 16, 2013