Can Targeted Elimination of B-cell Depletion Therapy and/or Combination Therapy on Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00556192
• Date of registration: 08/11/2007
• Prospective Registration: No
• Primary sponsor: Chinese University of Hong Kong
• Public title: Can Targeted Elimination of B-cell Depletion Therapy and/or Combination Therapy on Systemic Lupus Erythematosus
• Scientific title: Can Targeted Elimination of B-cell Depletion Therapy and/or Combination Therapy Restore Peripheral B Cell Abnormalities in Systemic Lupus Erythematosus(SLE)?
• Date of first enrolment: June 2006
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00556192
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Edmund Kwok Ming LI, MD
• Affiliation: Chinese University of Hong Kong

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age > 18 years

- Active proliferative lupus nephrites

- Biopsy confirmed active proliferative lupus nephritis within 3 months prior to
enrollment

- Proteinuria >= 2g/day

- Active urinary sediments

- Activity index of >= 6

- Elevated anti-double-stranded(anti-dsDNA) level at baseline

- Agreement to practice birth control

- SLE according to the American College of Rheumatology Criteria

- Informed consent was obtained

Exclusion Criteria:

- Pre-existing renal failure

- History of cancer

- Human immunodeficiency virus infection

- Active hepatitis B or C infection

- Active tuberculosis

- Diabetes mellitus

- A ny other chronic disease

- Unwillingness to comply with the protocol



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: rituximab

Primary Outcome(s)

-Estimated glomerular filtration rate(FRR) of >90 mil/minute.1.73m2 -Urinary protein:urinary creatinine ratio of <0.2 -Inactive urinary sediment [Time Frame: wk48]

Secondary Outcome(s)

-The estimated GFR,urinary protein values and urinary sediment -Changes in disease activity score(SLEDAI) -Other clinical features -Duration of B-cell depletion [Time Frame: baseline,wk0,wk4,wk8,wk12,wk24,wk36,wk48]

Secondary ID(s)

SLE-2005-006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors