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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00234897
First Posted: October 10, 2005
Last Update Posted: August 29, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00234897     History of Changes
Other Study ID Numbers: M04-684
HERO
First Submitted: September 13, 2005
First Posted: October 10, 2005
Last Update Posted: August 29, 2007
Last Verified: August 2007

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
Antirheumatic Agents