N/A
Completed N=92
A Prospective Study of Cyclophosphamide in Systemic Lupus Erythematosus Treatment
Source: ClinicalTrials.gov NCT01689350 ↗Enrolled (actual)
92
Serious AEs
27.2%
Results posted
Sep 2014
Primary outcomePrimary: Adverse Reaction (Leucopenia) — 6; 19 participants — p=<0.01
Summary
The purpose of this study is to compare the genotype-based personal prescription of cyclophosphamide with the traditional prescription.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Reaction (Leucopenia) |
6; 19 | <0.01 sig |
| SECONDARY Adverse Reaction ( Infection ) |
8; 16 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- The American College of Rheumatology established eleven criteria in 1982,which were revised in 1997 as a classificatory instrument to operationalise the definition of SLE in clinical trials.
- Malar rash (rash on cheeks).
- Discoid rash (red, scaly patches on skin that cause scarring).
- Serositis: Pleurisy (inflammation of the membrane around the lungs) or pericarditis (inflammation of the membrane around the heart).
- Oral ulcers (includes oral or nasopharyngeal ulcers).
- Arthritis: nonerosive arthritis of two or more peripheral joints, with tenderness, swelling, or effusion.
- Photosensitivity (exposure to ultraviolet light causes rash, or other symptoms of SLE flareups).
- Blood-hematologic disorder-hemolytic anemia (low red blood cell count) or leukopenia (white blood cell count
- HIV (-);
- Signed the informed consent;
- Taking contraceptive measures during treatment period.
Exclusion Criteria
- Poor compliance;
- With lupus mental damage complication, occurrence of epilepsy or unable to express subjective symptoms during the observation period.
- Taking drugs that affect cytochrome P450 2B6, cytochrome P450 3A4 and cytochrome P450 2C19, except corticosteroids.
- Abnormal liver function.
Data sourced from ClinicalTrials.gov (NCT01689350). 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.