Lupus Erythematosus, Systemic Clinical Trial
Official title:
An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Sbi-087 Administered To Subjects With Systemic Lupus Erythematosus.
| Verified date | December 2018 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE).
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | September 2012 |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Diagnosis of SLE (by greater than or equal to 4 American College of Rheumatology [ACR] Revised Criteria) greater than 6 months before study day 1. - History of a positive antinuclear antibody (ANA) titer greater than or equal to 1:160 or equivalent. Exclusion Criteria: - Treatment with more than 20 mg of prednisone per day. - Evidence of unstable clinically significant disease (e.g., cardiovascular, cerebrovascular, respiratory, or renal disease, or any other unstable serious disorder) other than SLE. - History of cancer (other than resected cutaneous basal and squamous cell carcinoma or in situ cervical cancer) with less than 5 years' documentation of a disease-free state. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Metroplex Clinical Research Center | Dallas | Texas |
| United States | Altoona Center for Clinical Research | Duncansville | Pennsylvania |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Arthritis & Rheumatology Care Center | South Miami | Florida |
| United States | Miami Research Associates | South Miami | Florida |
| United States | MRA Clinical Research | South Miami | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer | Emergent Product Development Seattle LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety (physical examinations, laboratory tests, adverse events) and tolerability (dose-limiting toxicities) of ascending single doses of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE) | 12 months | ||
| Secondary | Initial pharmacokinetic and pharmacodynamic profiles of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE) | 12 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
| Recruiting |
NCT05967520 -
JMKX000189 for Moderate to Severe Active Systemic Lupus Erythematosus
|
Phase 2 | |
| Completed |
NCT02875691 -
Effect of Green Tea on Treatment of Lupus
|
Phase 2 | |
| Completed |
NCT02922114 -
Comparison of the Clinical Examination and the Joint Ultrasonography in Lupus Patients
|
N/A | |
| Withdrawn |
NCT01702038 -
Determining the Responses and Impact of Rituximab-instigated Cell Depletion on T Cells in People With SLE
|
Phase 2 | |
| Terminated |
NCT00368264 -
TNF Blockade With Remicade in Active Lupus Nephritis WHO Class V (TRIAL )
|
Phase 2/Phase 3 | |
| Completed |
NCT00094380 -
Treating Systemic Lupus Erythematosus (SLE) Patients With CTLA4-IgG4m (RG2077)
|
Phase 1/Phase 2 | |
| Completed |
NCT00065806 -
Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)
|
Phase 3 | |
| Completed |
NCT00005436 -
Lupus Cohort--Thrombotic Events and Coronary Artery Disease
|
N/A | |
| Recruiting |
NCT03543839 -
Trial of Belimumab in Early Lupus
|
Phase 4 | |
| Completed |
NCT03098823 -
A Crossover Study to Compare RAYOS to IR Prednisone to Improve Fatigue and Morning Symptoms for SLE
|
Phase 4 | |
| Recruiting |
NCT05899907 -
Efficacy and Safety of Telitacicept in Early SLE
|
Phase 4 | |
| Completed |
NCT04956484 -
Belimumab In Early Systemic Lupus Erythematosus
|
Phase 4 | |
| Completed |
NCT05326841 -
Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients .
|
Phase 3 | |
| Completed |
NCT02655640 -
The Impact of Illness Perceptions on Health Related Outcomes in Patients With Lupus and Systemic Sclerosis
|
N/A | |
| Completed |
NCT02034344 -
A Study of Skin and Systemic Biomarkers In Patients With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers
|
Phase 0 | |
| Terminated |
NCT00089804 -
Study of LJP 394 in Lupus Patients With History of Renal Disease
|
Phase 3 | |
| Completed |
NCT00071487 -
Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)
|
Phase 2 | |
| Completed |
NCT02349061 -
A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus
|
Phase 2 | |
| Recruiting |
NCT05636670 -
Assessment of Cognitive Function and Gut Microbiota Analysis in Real World Patients With Lupus Cerebrovascular Disease
|