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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 19, 2014