Safety, Efficacy and Pharmacokinetics of an Antibody for Psoriatic Arthritis
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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. |
ClinicalTrials.gov Identifier: NCT00051662 |
Recruitment Status :
Completed
First Posted : January 16, 2003
Last Update Posted : June 24, 2005
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Sponsor:
XOMA (US) LLC
Information provided by:
XOMA (US) LLC
Tracking Information | |||
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First Submitted Date ICMJE | January 14, 2003 | ||
First Posted Date ICMJE | January 16, 2003 | ||
Last Update Posted Date | June 24, 2005 | ||
Study Start Date ICMJE | Not Provided | ||
Primary Completion Date | Not Provided | ||
Current Primary Outcome Measures ICMJE | Not Provided | ||
Original Primary Outcome Measures ICMJE | Not Provided | ||
Change History | No Changes Posted | ||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Safety, Efficacy and Pharmacokinetics of an Antibody for Psoriatic Arthritis | ||
Official Title ICMJE | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Safety, Efficacy and Pharmacokinetics of Efalizumab in Subjects With Psoriatic Arthritis | ||
Brief Summary | The purpose of this study is to determine whether a humanized monoclonal antibody (efalizumab) is safe and effective in the treatment of psoriatic arthritis (PsA) | ||
Detailed Description | A phase II, randomized, double-blind, placebo-controlled study to:
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Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 1 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Primary Purpose: Treatment |
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Condition ICMJE | Psoriatic Arthritis | ||
Intervention ICMJE | Drug: efalizumab | ||
Study Arms ICMJE | Not Provided | ||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Enrollment ICMJE |
45 | ||
Original Enrollment ICMJE | Same as current | ||
Study Completion Date ICMJE | February 2004 | ||
Primary Completion Date | Not Provided | ||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Not Provided | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00051662 | ||
Other Study ID Numbers ICMJE | HUPA600 | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Not Provided | ||
Study Sponsor ICMJE | XOMA (US) LLC | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | XOMA (US) LLC | ||
Verification Date | September 2004 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |