Phase 1
Completed N=9
Phase I Study in China - Tolerability of a Single Dose of Abatacept 30 mg/kg
Source: ClinicalTrials.gov NCT00705367 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Jun 2010
Primary outcomePrimary: Short-term Period: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, Discontinuations and Infusional AEs — 0; 0; 0; 0 Participants
Summary
The purpose of this study is to determine whether abatacept at a dose 30 mg/kg via intravenous infusion is safe and well tolerated in the treatment of lupus nephritis in mainland Chinese subjects with systemic lupus erythematosus (SLE)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Short-term Period: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, Discontinuations and Infusional AEs |
0; 0; 0; 0; 3; 1 | — |
| PRIMARY Short-term Period: Number of Adverse Events (AEs) Related to Study Drug |
1; 0; 1; 0; 0; 1 | — |
| PRIMARY Short-term Period: MeanSystolic and Diastolic Blood Pressure |
129.0; 133.0; 125.8; 131.7; 84.2; 78.3 | — |
| PRIMARY Short-term Period: Mean Heart Rate |
77.0; 81.0; 81.2; 87.7; 83.5; 84.0 | — |
| PRIMARY Short-term Period: Mean Respirations Rate |
17.7; 19.7; 18.7; 20.3; 14.0; 17.3 | — |
| PRIMARY Short-term Period: Mean Temperature |
36.7; 36.7; 36.8; 36.9; 36.9; 36.9 | — |
| PRIMARY Short-term Period: Number of Participants With Clinical Laboratory and Electrocardiogram (ECG) Abnormalities |
0; 0; 0; 0 | — |
| SECONDARY Long-term Period: Number of Participants With Death as Outcome, Serious AEs (SAEs), Discontinuations Due to AEs, and Treatment-related AEs |
0; 0; 2; 8; 6 | — |
| SECONDARY Minimum (Cmin) Plasma Concentration of Abatacept |
55.47; 42.69; 18.54; 22.66; 28.24; 25.98 | — |
| SECONDARY Maximum (Cmax) Plasma Concentration of Abatacept |
463.10 | — |
| SECONDARY Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests |
1; NA; 1; NA; 0; NA | — |
| SECONDARY Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) |
NA; 0; NA; 0; NA; 0 | — |
| SECONDARY Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued) |
NA; 0; NA; 0; NA; 0 | — |
| SECONDARY Long-term Period: Number of Participants With Abatacept-specific Antibodies |
— | — |
Eligibility Criteria
Inclusion Criteria
- Men and women, at least 18 years of age, with a diagnosis of systemic lupus erythematosus (SLE) and with lupus nephritis currently stable for the last 3 months without change in treatment for lupus nephritis
- Stable renal disease
- No flaring of other organ systems in a minimum of the last 3 months
Exclusion Criteria
- Unstable lupus nephritis and serum creatinine >3 mg/dL
- Progressive renal failure, end stage renal disease, or renal transplant requiring continuous dialysis
- Severe unstable, refractory, or progressive SLE
- History of cancer
- Participants at risk for tuberculosis
- Autoimmune disease other than SLE as main diagnosis
- Human immunodeficiency virus or herpes zoster infection
- Hepatitis-B surface antigen-positive or hepatitis C antibody-positive participants
Data sourced from ClinicalTrials.gov (NCT00705367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.