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Sponsored by: |
Chinese University of Hong Kong |
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Information provided by: | Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT00556192 |
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.
Condition | Intervention | Phase |
---|---|---|
Systemic Lupus Erythematosus |
Drug: rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Can Targeted Elimination of B-Cell Depletion Therapy and/or Combination Therapy Restore Peripheral B Cell Abnormalities in Systemic Lupus Erythematosus(SLE)? |
Estimated Enrollment: | 20 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Rituximab
|
Drug: rituximab
|
2: Active Comparator
Rituximab + Cyclophosphamide
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Drug: rituximab
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3: Active Comparator
Cyclophosphamide
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Drug: rituximab
|
Twenty patients will be randomized into 3 treatment arms to receive:
Clinical examination and laboratory investigations will be performed at 0, 4, 8, 12, 24, 36 and 48 weeks from the time of treatment. At each visit, patients will be evaluated for clinical manifestation of SLE and side effects of therapy. Laboratory parameters measured included the complete blood cell count with differential and platelet counts, chemistries survey, urinalysis, and 24- hour urinary for protein excretion and creatinine clearance.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
China | |
Department of Medicine and Therapeutics | |
Hong Kong, China |
Principal Investigator: | Edmund Kwok Ming LI, MD | Chinese University of Hong Kong |
Responsible Party: | The Chinese University of Hong Kong ( Lai-Shan Tam ) |
Study ID Numbers: | SLE-2005-006 |
Study First Received: | November 8, 2007 |
Last Updated: | May 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00556192 |
Health Authority: | Hong Kong: Department of Health |
SLE Rituximab Methylprednisolone Cyclophosphamide |
Azathioprine Autoimmune Diseases Lupus Erythematosus, Systemic Methylprednisolone Rituximab Prednisolone |
Connective Tissue Diseases Methylprednisolone acetate Prednisolone acetate Cyclophosphamide Congenital Abnormalities Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics Hormones Glucocorticoids Protective Agents |
Neuroprotective Agents Immunosuppressive Agents Pharmacologic Actions Autonomic Agents Therapeutic Uses Myeloablative Agonists Peripheral Nervous System Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Central Nervous System Agents Alkylating Agents |