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Tracking Information | |||||
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First Received Date † | October 7, 2005 | ||||
Last Updated Date | August 28, 2007 | ||||
Start Date † | July 2005 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † |
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Change History | Complete list of historical versions of study NCT00235885 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
No differentiation will be made between primary and secondary efficacy variables. | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Safety and Efficacy Study of Adalimumab in Patients With Active Psoriatic Arthritis (PsA) | ||||
Official Title † | Safety and Efficacy of Adalimumab in Patients With Active Psoriatic Arthritis (PsA) - An Open-Label, Multinational Study to Evaluate the Response to Every-Other Week Adalimumab When Added to Insufficient Standard Therapy, Including Patients Who Failed Prior Treatment With Other TNF-Inhibitors (STEREO) | ||||
Brief Summary | The purpose of the study is to assess the safety and clinical efficacy of adalimumab in active psoriatic arthritis (PsA) subjects when adalimumab is added to insufficient standard therapy including patients that have failed other TNF therapies |
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Detailed Description | |||||
Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † | Psoriatic 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. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 445 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00235885 | ||||
Responsible Party | |||||
Secondary IDs †† | EudraCT: 2005/001185-14 | ||||
Study Sponsor † | Abbott | ||||
Collaborators †† | |||||
Investigators † |
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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. |