Trial Outcomes & Findings for A Prospective Study of Cyclophosphamide in Systemic Lupus Erythematosus Treatment (NCT NCT01689350)

NCT ID: NCT01689350

Last Updated: 2014-09-08

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 92 participants
• Primary outcome timeframe: one month
• Results posted on: 2014-09-08

Participant Flow

Participant milestones

Measure	Experimental Group Cyclophosphamide (CPA) medication was according to the genotypes of SLE patients.	Control Group Cyclophosphamide (CPA) medication was according to the traditional experiences.
Overall Study STARTED	47	45
Overall Study COMPLETED	47	45
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Prospective Study of Cyclophosphamide in Systemic Lupus Erythematosus Treatment

Baseline characteristics by cohort

Measure	Control Group n=45 Participants 45 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 n=47 Participants 47 cases in experimental group were genotyped as 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.	Total n=92 Participants Total of all reporting groups
Age, Continuous	30.40 years STANDARD_DEVIATION 13.28 • n=5 Participants	31.15 years STANDARD_DEVIATION 13.21 • n=7 Participants	30.78 years STANDARD_DEVIATION 13.17 • n=5 Participants
Sex/Gender, Customized Female	38 participants n=5 Participants	40 participants n=7 Participants	78 participants n=5 Participants
Sex/Gender, Customized Male	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Race/Ethnicity, Customized Chinese Han	45 participants n=5 Participants	47 participants n=7 Participants	92 participants n=5 Participants
Region of Enrollment China	45 participants n=5 Participants	47 participants n=7 Participants	92 participants n=5 Participants
SLE patients	45 participants n=5 Participants	47 participants n=7 Participants	92 participants n=5 Participants

PRIMARY outcome

Timeframe: one month

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

Outcome measures

Measure	Experimental Group n=47 Participants CPA medication was according to the genotypes of SLE patients.	Control Group n=45 Participants CPA medication was according to the traditional experiences.
Adverse Reaction (Leucopenia)	6 participants Interval 1.76 to 14.14	19 participants Interval 1.76 to 14.14

SECONDARY outcome

Timeframe: one month

Flu-like symptoms, Upper respiratory tract infection，and the etc.

Outcome measures

Measure	Experimental Group n=47 Participants CPA medication was according to the genotypes of SLE patients.	Control Group n=45 Participants CPA medication was according to the traditional experiences.
Adverse Reaction ( Infection )	8 participants	16 participants

Adverse Events

Experimental Group

Serious events: 6 serious events

Other events: 8 other events

Deaths: 0 deaths

Control Group

Serious events: 19 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Experimental Group n=47 participants at risk Cyclophosphamide (CPA) medication was according to the genotypes of SLE patients.	Control Group n=45 participants at risk Cyclophosphamide (CPA) medication was according to the traditional experiences.
Blood and lymphatic system disorders Leucopenia	12.8% 6/47 • One month for all the adverse events reporting.	42.2% 19/45 • One month for all the adverse events reporting.

Other adverse events

Measure	Experimental Group n=47 participants at risk Cyclophosphamide (CPA) medication was according to the genotypes of SLE patients.	Control Group n=45 participants at risk Cyclophosphamide (CPA) medication was according to the traditional experiences.
Infections and infestations Infection	17.0% 8/47 • One month for all the adverse events reporting.	35.6% 16/45 • One month for all the adverse events reporting.

Additional Information

Lingyan CHEN, Master candidate

School of Pharmaceutical Sciences, Sun Yat-sen University

Phone: +8615018706960

Email: chlingy@mail2.sysu.edu.cn

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60