Safety and Tolerability of MEDI-545 in Patients Who Have Systemic Lupus Erythematosus (SLE)
Public ClinicalTrials.gov record NCT00299819. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I, Randomized, Double-Blind, Placebo Controlled, Dose-Escalation Study to Evaluate Safety and Tolerability of a Single IV Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Patients With Systemic Lupus Erythematosus (SLE)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to evaluate the safety and tolerability of intravenously administered MEDI-545 compared with placebo, over a dose escalation range of 0.3-30 mg/kg, in adult patients with SLE and who are receiving 20 mg/day or less of prednisone orally or an equivalent dose of another oral corticosteroid.
Study identification
- NCT ID
- NCT00299819
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 45 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2006 (Type not available)
- Primary completion
- Not listed
- Completion
- Oct 2007 (Actual)
- Last update posted
- Dec 18, 2007
2006 – 2007
United States locations
- U.S. sites
- 19
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group | Anniston | Alabama | 35207 | — |
| Wallace Rheumatic Study Center | Los Angeles | California | 90048 | — |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | — |
| Center for Rhematology, Immunology, and Arthritis | Fort Lauderdale | Florida | 03334 | — |
| Ocala Rheumatology Research Center | Ocala | Florida | 34474 | — |
| Tampa Florida Medical Research Group | Tampa | Florida | 33614 | — |
| Florida Medical Clinic, Clinical Research Division | Zephyrhills | Florida | 33542 | — |
| Louisiana State University Health Sciences Center-Shreveport | Shreveport | Louisiana | 71130 | — |
| Johns Hopkins University, School of Medicine | Baltimore | Maryland | 21205 | — |
| St. Mary's Duluth Clinic | Duluth | Minnesota | 55805 | — |
| Hospital for Special Surgery | New York | New York | 10021 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 | — |
| Oregon Medical Research Center | Portland | Oregon | 97223 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| University of Washington Div. of Rhematology | Seattle | Washington | 98195 | — |
| Center for Innovative Therapy, UCSD School of Medicine | Milwaukee | Wisconsin | 53226 | — |
| Froedtert Hospital, Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00299819, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 18, 2007 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00299819 live on ClinicalTrials.gov.