NCT00556192

Brief Summary

This prospective randomized control trial is undertaken to evaluate the safety and efficacy of anti-CD20 monoclonal antibody, rituximab, used as 1. monotherapy, 2. in combination with cyclophosphamide, in the treatment of proliferative lupus nephritis, as compared with standard immunosuppressive therapy with cyclophosphamide and azathioprine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 13, 2012

Status Verified

February 1, 2012

Enrollment Period

3.5 years

First QC Date

November 8, 2007

Last Update Submit

February 10, 2012

Conditions

Systemic Lupus Erythematosus

Keywords

SLERituximabMethylprednisoloneCyclophosphamide

Outcome Measures

Primary Outcomes (1)

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

    wk48

Secondary Outcomes (1)

  • -The estimated GFR,urinary protein values and urinary sediment -Changes in disease activity score(SLEDAI) -Other clinical features -Duration of B-cell depletion

    baseline,wk0,wk4,wk8,wk12,wk24,wk36,wk48

Study Arms (3)

1

ACTIVE COMPARATOR

Rituximab

Drug: rituximab

2

ACTIVE COMPARATOR

Rituximab + Cyclophosphamide

Drug: rituximab

3

ACTIVE COMPARATOR

Cyclophosphamide

Drug: rituximab

Interventions

rituximabDRUG

1. Rituximab of 1000 mg given 2 weeks apart. On day the of rituximab, and 'pulse' methylprednisolone 250mg IV be given followed by prednisolone 30mg/day from Day 2 to Day 5. 2. A treatment dose rituximab of 1000mg given 2 weeks apart and 'pulse' methylprednisolone 250mg IV be given followed by prednisolone 30mg/day from Day 2 to Day 5, and 'pulse' cyclophosphamide 500mg/m2 at baseline and day 14. 3. Sequential therapy with oral cyclophosphamide (50 to 100 mg/day) for 6 months followed by azathioprine (up to 2.5mg/kg/day) for maintenance up to 12 months. Oral prednisolone will be given at 0.5 mg/kg/day (up to 30 mg daily) for 4 weeks, tapered by 5 mg every 2 weeks thereafter until 5mg /day for the rest of the study period.

Also known as: Mabthera
123

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine and Therapeutics

Hong Kong, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Edmund Kwok Ming LI, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 8, 2007

First Posted

November 9, 2007

Study Start

June 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

February 13, 2012

Record last verified: 2012-02

Locations

CN(1)