|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 27, 2006 | ||||
| Last Updated Date | September 27, 2006 | ||||
| Start Date ICMJE | May 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study to Evaluate the Effects of Efalizumab on Immune Responses in Subjects With Moderate Plaque Psoriasis | ||||
| Official Title ICMJE | A Randomized, Placebo-Controlled, Single-Blind, Parallel-Group Study to Evaluate the Effects of 12 Weekly Subcutaneous Doses of 1.0 mg/kg Efalizumab on Immune Responses in Subjects With Moderate Plaque Psoriasis | ||||
| Brief Summary | This is a Phase I, randomized, placebo-controlled, single blind, parallel group, single-center study designed to evaluate immune responses during and after administration of 12 weekly SC doses of 1.0 mg/kg efalizumab in subjects with moderate plaque psoriasis. |
||||
| Detailed Description | |||||
| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Allocation: Randomized Control: Placebo Control Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
||||
| Condition ICMJE | Plaque Psoriasis | ||||
| Intervention ICMJE | Drug: Raptiva (efalizumab) | ||||
| 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 ICMJE | Completed | ||||
| Enrollment ICMJE | 60 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00382512 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | ACD2244g | ||||
| Study Sponsor ICMJE | Genentech | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | Genentech | ||||
| Verification Date | September 2006 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||