TNF Blockade With Remicade in Active Lupus Nephritis WHO Class V (TRIAL )

Summary

Background:

Standard therapy is ill-defined for patients with systemic lupus erythematosus (SLE) suffering from the membraneous form of Lupus nephritis (WHO class V). Therapeutic options used at present include azathioprine.

In a small, open label safety study, patients with lupus nephritis, including patients with membraneous lupus nephritis, have experienced a long-lasting therapeutic response, with sustained reduction in proteinuria, following a 10 weeks course of 4 infusions of infliximab in combination with azathioprine. This short course appeared safe with regard to SLE activity, despite increases in autoantibody levels.

Study hypothesis:

1. The combination of four infusions of infliximab (5 mg/kg of body weight)administered at weeks 0, 2,6, and 10, with azathioprine will be faster than azathioprine alone in reducing proteinuria to less than 1.5 g/day in patients with active lupus nephritis WHO class V (proteinuria \> 3g/day).
2. This combination therapy will show a tolerable safety profile with regard to SLE activity and infections.

Conditions

• Lupus Erythematosus, Systemic
• Lupus Nephritis

Interventions

DRUG

infliximab

azathioprine (2 mg/lkg) plus four infusions of infliximab (5mg/kg)

DRUG

placebo

azathioprine (2 mg/kg) plus four placebo infusions

Sponsors & Collaborators

• Hospital Hietzing

  collaborator OTHER

• Medical University of Graz

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• University of Erlangen-Nürnberg

  collaborator OTHER

• Heinrich-Heine University, Duesseldorf

  collaborator OTHER

• University Medical Center Groningen

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• Medical University of Vienna

  lead OTHER

Principal Investigators

• Josef S Smolen, MD · Head, Department of Rheumatology, Internal Medicine III, Medical University of Vienna, Austria

• Martin Aringer, MD · Department of Rheumatology, Internal Medicine III, Medical University of Vienna, Austria

• Falk Hiepe, MD · Rheumatology, Charite, Berlin, Germany

• Marc Bijl, MD · Clinical Immunology, Groningen University Hospital, Netherlands

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-09-30

Primary Completion

2009-06-30

Completion

2009-06-30

Countries

• Austria
• Germany
• Netherlands

Study Locations