Back to resultsEfficacy of HUMIRA in Subjects With Active Rheumatoid Arthritis (HERO)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring adalimumab, rheumatoid arthritis
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
Sites / Locations
- Global Medical Information - Abbott
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00234897
Brief Title
Efficacy of HUMIRA in Subjects With Active Rheumatoid Arthritis
Acronym
HERO
Official Title
Humira Efficacy Response Optimization Study in Subjects With Active Rheumatoid Arthritis (HERO)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
adalimumab, rheumatoid arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1938 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
adalimumab
Primary Outcome Measure Information:
Title
Patient reported outcomes, clinical response indicators.
Secondary Outcome Measure Information:
Title
Subject reported assessments of disease activity, physician reported assessments of disease activity, safety parameters, clinical response indicators.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beverly Paperiello
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Global Medical Information - Abbott
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of HUMIRA in Subjects With Active Rheumatoid Arthritis
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