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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00368264
Date of registration: 23/08/2006
Prospective Registration: Yes
Primary sponsor: Medical University of Vienna
Public title: TNF Blockade With Remicade in Active Lupus Nephritis WHO Class V (TRIAL )
Scientific title: A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNF-alpha Chimeric Monoclonal Antibody (Infliximab) and Azathioprine in Patients Suffering From Systemic Lupus Erythematosus (SLE) With WHO Class V Glomerulonephritis
Date of first enrolment: September 2006
Target sample size: 1
Recruitment status: Terminated
URL:  http://clinicaltrials.gov/show/NCT00368264
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment  
Phase:  Phase 2/Phase 3
Countries of recruitment
Austria Germany Netherlands
Contacts
Name:     Marc Bijl, MD
Address: 
Telephone:
Email:
Affiliation:  Clinical Immunology, Groningen University Hospital, Netherlands
Name:     Martin Aringer, MD
Address: 
Telephone:
Email:
Affiliation:  Department of Rheumatology, Internal Medicine III, Medical University of Vienna, Austria
Name:     Josef S Smolen, MD
Address: 
Telephone:
Email:
Affiliation:  Head, Department of Rheumatology, Internal Medicine III, Medical University of Vienna, Austria
Name:     Falk Hiepe, MD
Address: 
Telephone:
Email:
Affiliation:  Rheumatology, Charite, Berlin, Germany
Key inclusion & exclusion criteria

Inclusion Criteria:

- SLE (ACR criteria fulfilled) with biopsy-proven membranous glomerulonephritis (WHO
class V).

- Proteinuria > 3 g/day despite adequate therapy with ACE inhibitors and steroids (at
least 2 months treatment with steroids with a dose at any time of at least 50 mg
prednisolone (or equivalent), and ACE inhibitors and/or AT II antagonists at their
maximum daily dose or, if this cannot be reached, the maximum daily dose tolerated).

- Capacity to understand and sign an informed consent form.

- Men and women of childbearing potential must use adequate birth control measures for
the duration of the study and should continue such precautions for 6 months after
receiving the last infusion.

- No history of latent or active TB prior to screening.

- No signs or symptoms suggestive of active TB upon medical history and/or physical
examination.

- No recent close contact with a person with active TB or, if there has been such
contact, will be referred to a physician specializing in TB to undergo additional
evaluation and, if warranted, receive appropriate treatment for latent TB prior to or
simultaneously with the first administration of study agent.

- Within 1 month prior to the first administration of study agent, either have a
negative tuberculin skin test, or have a newly identified positive tuberculin skin
test during screening in which active TB has been ruled out and for which appropriate
treatment for latent TB has been initiated either prior to or simultaneously with the
first administration of study agent.

- Have a chest radiograph (both posterior-anterior and lateral views) with no evidence
of current active TB or old inactive TB.

- Screening laboratory test results meet the following criteria:

- WBC (white blood cell count): > 3.0 109/L

- Hemoglobin: > 6 mmol/L (9,6 g/dL)

- Platelets: 100-350 109/L

- Serum Creatinine: 1.5 times the upper limit of normal range

- ALAT / ASAT within twice the upper normal range.

Exclusion Criteria:

- Active WHO class IV SLE nephritis.

- Treatment with Azathioprine within the previous 12 months.

- Treatment with cyclophosphamide within the previous 12 months.

- Treatment with cyclosporine within the previous 6 weeks.

- Active cerebral SLE

- Presence of anti-phospholipid-antibodies unless under adequate anticoagulation

- Women who are pregnant, nursing, or planning pregnancy within 6 months after the last
infusion.

- Have had any previous treatment with monoclonal antibodies or antibody fragments.

- History of receiving human/murine recombinant products or a known allergy to murine
products. A known allergy to murine product is definitely an exclusion criterion

- Documentation of seropositive for human immunodeficiency virus (HIV).

- A positive test for hepatitis B surface antigen or hepatitis C.

- Alcohol or substance abuse

- Known history of serious infections in the previous 3 months.

- Opportunistic infection within 6 months prior to screening.

- History of latent or active granulomatous infection.

- Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening.

- Chest radiograph within 3 months prior to randomization suggestive of malignancy or
current active infection.

- Nontuberculous mycobacterial infection or opportunistic infection within 6 months
prior to screening.

- History of lymphoproliferative disease.

- Any known malignancy or history of malignancy within the previous 5 years, with the
exception of basal cell or squamous cell carcinoma of the skin that has been fully
excised with no evidence of recurrence.

- Current signs or symptoms of severe, progressive or uncontrolled renal (other than
disease under investigation), hepatic, hematologic, gastrointestinal, endocrine,
pulmonary, cardiac, neurologic, or cerebral disease.

- Use of any investigational drug within 30 days prior to screening or within 5
half-lives of the investigational agent, whichever is longer.

- Previous treatment with drugs targeted at reducing TNF.

- Presence of a transplanted solid organ (with the exception of a corneal transplant >
3 months prior to screening).

- Concomitant diagnosis or history of congestive heart failure.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Lupus Erythematosus, Systemic
Lupus Nephritis
Intervention(s)
Drug: infliximab
Drug: placebo
Primary Outcome(s)
Comparison of time needed to reduce proteinuria to 1.5 g/day or less between the infliximab plus azathioprine and the azathioprine only group. [Time Frame: No]
Secondary Outcome(s)
Absolute reduction in proteinuria at 6 weeks, 12 weeks, 20 weeks, 36 weeks, and 52 weeks after the first infusion. [Time Frame: No]
Absolute reduction in SLE disease activity (measured by SIS and SLEDAI). [Time Frame: Yes]
Changes in Fatigue as determined by the FSS (Fatigue Severity Scale). [Time Frame: No]
Changes in Quality of life as determined by the SF36 questionnaire. [Time Frame: No]
Percent reduction in protein/ creatinine ratio. [Time Frame: No]
Percent reduction in proteinuria at 6 weeks, 12 weeks, 20 weeks, 36 weeks, and 52 weeks after the first infusion. [Time Frame: No]
Percent reduction in SLE disease activity (measured by SIS and SLEDAI). [Time Frame: Yes]
Percentage of patients reaching reduction in proteinuria to = 1.5 g/day, at week 12 and week 52. [Time Frame: No]
Secondary ID(s)
EK Nr:110/2006
Eudract-Nr. 2005-004067-30
Protocol EU-116
TRIAL V
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Charite University, Berlin, Germany
Heinrich-Heine University, Duesseldorf
Hospital Hietzing
Leiden University Medical Center
Medical University of Graz
Radboud University
University Medical Centre Groningen
University of Erlangen-N├╝rnberg
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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