A Prospective Study of Cyclophosphamide in Systemic Lupus Erythematosus Treatment

NCT01689350 | Completed Results DMC

• 1 other identifier: 2012ZX09506001-004
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the genotype-based personal prescription of cyclophosphamide with the traditional prescription.

Conditions

Systemic Lupus Erythematosus

Keywords

Cyclophosphamide; genotype-based therapy; prospective study

Outcome Measures

Primary Outcomes (1)

• Adverse Reaction (Leucopenia)

  The count of white cells \< 4.0 × 10ˆ9/L in SLE patient who received CPA medication was considered as CPA-induced leucopenia.

  one month

Secondary Outcomes (1)

• Adverse Reaction ( Infection )

  one month

Study Arms (2)

Control Group

NO INTERVENTION

The cases in control group received traditional therapy that the initial dose of cyclophosphamide (CPA) was 0.2-0.6g/week injection according to clinical experience.

Experimental Group

EXPERIMENTAL

Genetic: Genotype Detection To Genotype cases in the experimental group and divide them into three groups, including extensive metaboliser (EM), intermediate metaboliser (IM) and poor metaboliser (PM),with initial dose of CPA as 0.2g, 0.4g and 0.6g per week by injection, respectively.

Genetic: Genotype Detection

Interventions

Genotype Detection GENETIC

To Genotype cases in the experimental group and divide them into three groups, including extensive metaboliser (EM), intermediate metaboliser (IM) and poor metaboliser (PM).

Experimental Group

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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\<4000/µl), lymphopenia (\<1500/µl) or thrombocytopenia (\<100000/µl) in the absence of offending drug. Hypocomplementemia is also seen, due to either consumption of C3 and C4 by immune complex-induced inflammation or to congenitally complement deficiency, which may predispose to SLE.
• Renal disorder: More than 0.5 g per day protein in urine or cellular casts seen in urine under a microscope.
• Antinuclear antibody test positive.
• Immunologic disorder: Positive anti-Smith, anti-ds DNA, antiphospholipid antibody, and/or false positive serological test for syphilis. Presence of anti-ss DNA in 70% of cases (though also positive with rheumatic disease and healthy persons).
• Neurologic disorder: Seizures or psychosis. For the purpose of identifying patients for clinical studies, a person has SLE if any 4 out of 11 symptoms are present simultaneously or serially on two separate occasions. In the meantime, the case has one of the following conditions or more;
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• HIV (-);
• Signed the informed consent;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (1)

School of Pharmaceutical Sciences Sun Yat-sen University

Guangzhou, Guangdong, 510006, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

The sample size is too small to evaluate the significance of the cyclophosphamide (CPA) medication based on genotypes. We need to enroll more SLE patients in the following study.

Results Point of Contact

• Title: Lingyan CHEN, Master candidate
• Organization: School of Pharmaceutical Sciences, Sun Yat-sen University

chlingy@mail2.sysu.edu.cn

+8615018706960

Study Officials

• Huang Min, PhD

  Sun Yat-sen University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Graduate Student

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 21, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: September 8, 2014
• Results First Posted: September 8, 2014

Record last verified: 2014-08

Locations

CN (1)