A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
Public ClinicalTrials.gov record NCT00137969. 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.
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Official title
Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With Moderate to Severe Systemic Lupus Erythematosus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab compared with placebo when combined with a single stable background immunosuppressive medication in subjects with moderate to severe systemic lupus erythematosus (SLE). The primary efficacy endpoint of the trial will be evaluated at 52 weeks.
Study identification
- NCT ID
- NCT00137969
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 262 participants
Conditions and interventions
Conditions
Interventions
- Rituximab Drug
- Placebo Drug
- Prednisone Drug
- Acetaminophen Drug
- Diphenhydramine Drug
Drug
Eligibility (public fields only)
- Age range
- 16 Years to 75 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
- May 10, 2005 (Actual)
- Primary completion
- Aug 25, 2008 (Actual)
- Completion
- Aug 25, 2008 (Actual)
- Last update posted
- Aug 20, 2019
2005 – 2008
United States locations
- U.S. sites
- 63
- U.S. states
- 27
- U.S. cities
- 54
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univ of Alabama School of Med; Clinical Immun Rheumatology | Birmingham | Alabama | 35294 | — |
| Rheumatology Assoc of North AL | Huntsville | Alabama | 35801 | — |
| Arizona Arthritis & Rheumatology Research, Pllc | Paradise Valley | Arizona | 85253 | — |
| Univ of California, San Diego | La Jolla | California | 92037 | — |
| Univ of Calif., Los Angeles; Rheumatology | Los Angeles | California | 90025 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Stanford University Med Ctr;Div of Immunology/Rheumatology | Palo Alto | California | 94304 | — |
| Univ of Calif, San Francisco; Rheumatology | San Francisco | California | 94143-0111 | — |
| Eden Medical Center San Leandro Hospital | San Leandro | California | 94578 | — |
| University of Colorado Denver | Aurora | Colorado | 80045 | — |
| Arthritis & Rheumatism; Disease Specialities | Aventura | Florida | 33180 | — |
| Family Arthritis Center | Jupiter | Florida | 33458 | — |
| Emory Uni ; Division of Rheumatology | Atlanta | Georgia | 30303 | — |
| Intermountain Research Center | Boise | Idaho | 83702 | — |
| Coeur D'Alene Arthritis Clinic | Coeur d'Alene | Idaho | 83814 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Rheumatology Associates | Chicago | Illinois | 60612 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Tri-State Arth & Rheum Center | Evansville | Indiana | 47714 | — |
| Univ of Kansas Medical Center; Allergy/Clin Imm/Rheum | Kansas City | Kansas | 66160 | — |
| Kentuckiana Cancer Institute | Louisville | Kentucky | 40202 | — |
| LA State Univ; Medicine | Shreveport | Louisiana | 71103 | — |
| Johns Hopkins Uni | Baltimore | Maryland | 21205 | — |
| Center For Rheumatology & Bone Research | Wheaton | Maryland | 20902 | — |
| Tufts - New England Medical Center | Boston | Massachusetts | 02111 | — |
| Dana-Farber Cancer Institute; Rheumatology | Boston | Massachusetts | 02215-5501 | — |
| University Of Michigan | Ann Arbor | Michigan | 48109 | — |
| Michigan Arthritis Rsrch Ctr | Brighton | Michigan | 48116 | — |
| Washington University; Rheumatology Division | St Louis | Missouri | 63110 | — |
| Center for Rheumatology, State Uni. of New York | Albany | New York | 12206 | — |
| SUNY Downstate Medical Center. | Brooklyn | New York | 11203 | — |
| NS-LIJ Health Systems; Rheum-Allergy Clin Immu | Lake Success | New York | 11042 | — |
| Feinstein Institute for Medical Research | Manhasset | New York | 11030 | — |
| NYU-Hosp for Joint Diseases; Rheum and Med | New York | New York | 10003 | — |
| Hospital for Special Surgery | New York | New York | 10021 | — |
| Buffalo Rheumatology Associates | Orchard Park | New York | 14127 | — |
| Long Island Osteo/Arth Center | Plainview | New York | 11803 | — |
| University of Rochester - Strong Memorial Hospital | Rochester | New York | 14642 | — |
| University of North Carolina Hospitals Department of Pharmacy; Investigational Drug Services | Chapel Hill | North Carolina | 27514 | — |
| Duke Medical Center | Durham | North Carolina | 27710 | — |
| Physicians East Pa | Greenville | North Carolina | 27834 | — |
| Ohio State University; Division of Nephrology | Columbus | Ohio | 43210 | — |
| Bone and Joint Hospital at St. Anthony Research Department | Oklahoma City | Oklahoma | 73103 | — |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 | — |
| Oklahoma Center For Arthritis Therapy & Research | Tulsa | Oklahoma | 74104 | — |
| Portland Medical Associates | Portland | Oregon | 97224 | — |
| East Penn Rheumatology Associates, Pc | Bethlehem | Pennsylvania | 18015 | — |
| Altoona Arthritis & Osteo Center | Duncansville | Pennsylvania | 16635 | — |
| Uni of Pennslyvania Medical Center | Philadelphia | Pennsylvania | 19104 | — |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| Medical Univ of South Carolina | Charleston | South Carolina | 29425 | — |
| Arthritis Associates PLLC | Chattanooga | Tennessee | 37404 | — |
| Metroplex Clinical Research | Dallas | Texas | 75231 | — |
| Arthritis Centers of Texas | Dallas | Texas | 75246 | — |
| Houston Inst. For Clinical Research | Houston | Texas | 77074 | — |
| Arthritis & Osteoporosis Associates, LLP | Lubbock | Texas | 79424 | — |
| Texas Research Center | Sugar Land | Texas | 77479 | — |
| University of Virginia Med Ctr; Div of Ped Respiratory Med | Charlottesville | Virginia | 22908 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
| Seattle Rheumatology Assoc; Swedish Rheumatology Research | Seattle | Washington | 98104 | — |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | — |
| Arthritis Northwest, Spokane | Spokane | Washington | 99204 | — |
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 NCT00137969, 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 Aug 20, 2019 · Synced Nov 5, 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 NCT00137969 live on ClinicalTrials.gov.