Home
Search
Study Topics
Glossary
|
|
|
|
|
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date † | September 13, 2005 | ||||
Last Updated Date | August 28, 2007 | ||||
Start Date † | August 2004 | ||||
Current Primary Outcome Measures † |
Patient reported outcomes, clinical response indicators. | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00234897 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Subject reported assessments of disease activity, physician reported assessments of disease activity, safety parameters, clinical response indicators. | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Efficacy of HUMIRA in Subjects With Active Rheumatoid Arthritis | ||||
Official Title † | Humira Efficacy Response Optimization Study in Subjects With Active Rheumatoid Arthritis (HERO) | ||||
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 |
||||
Detailed Description | |||||
Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Rheumatoid Arthritis | ||||
Intervention † | Drug: adalimumab | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 1938 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00234897 | ||||
Responsible Party | |||||
Secondary IDs †† | HERO | ||||
Study Sponsor † | Abbott | ||||
Collaborators †† | |||||
Investigators † |
|
||||
Information Provided By | Abbott | ||||
Verification Date | August 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |