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Enteric-coated Mycophenolate Sodium Versus Azathioprine for the Extra-renal Lupus Manifestations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01112215
Recruitment Status : Completed
First Posted : April 28, 2010
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Study Description
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Brief Summary:
Azathioprine is still considered the treatment of choice for the non-renal manifestations of systemic lupus erythematosus (SLE) with an estimated efficacy of 45%.Recently, several studies have demonstrated the efficacy of mycophenolate mofetil/enteric-coated mycophenolate sodium in those cases, but so far, no controlled, randomized comparative study between the two drugs has been conducted. The aim is to perform a randomized, controlled, phase III/IV study comparing enteric-coated mycophenolate (ECMs) with azathioprine for induction and maintenance therapy of the non-renal manifestations of SLE. Methods: Patients with non-renal SLE flares (SLEDAI≥6 and/or BILAG o 2B refractory to full doses of hydroxychloroquine and prednisolone (≥10 mg/d) or with relapsing flares will be included. Patients will be stratified according the flare severity (moderate (SLEDAI<12)-severe (SLEDAI≥12)) and randomized (1:1) into two groups of treatment, EMCs (2gr/d) or AZA (2-2.5mg/kg/d) according to TMPT levels for 6 months. Dose will be progressively tapered based on clinical response up to completing a year of treatment. The main aim is the percentage of complete remission achieved ((SLEDAI <4 and/or absence of any BILAG A o B) at week 12 and 24 for moderate and severe flares, respectively. Secondary objectives include evaluating the reduction in the steroid requirement, number of flares post-treatment, effect on the biological parameters, and impact on quality of life, damage and drug safety. To detect a 20% difference between the two drugs with a 80% statistical power (0.05 alpha error), considering a follow up loss of 20%, a total of 240 patients is required.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Azathioprine Drug: Enteric-Coated Mycophenolate Sodium Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Evaluate the Efficacy of Enteric-coated Mycophenolate Sodium Versus Azathioprine for the Induction and Maintenance of Remission of the Extra-renal Lupus Manifestations
Study Start Date : December 2009
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: azathioprine Drug: Azathioprine
Initial dose of 2-2.5 mg/kg (according to TMTP levels) for 6 months according the severity of the flare with progressive tapering if complete remission has been obtained
Active Comparator: Enteric-coated Mycophenolate Sodium Drug: Enteric-Coated Mycophenolate Sodium
Initial dose of 1440 mg/day for 6 months to be tapered progressively if complete remission had been obtained


Outcome Measures
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Primary Outcome Measures :
  1. Obtention of complete remission [ Time Frame: 24 months ]
    Complete remission will be defined by a SLEDAI<4 and/or absence of any BILAG A or B after 12 weeks of treatment


Secondary Outcome Measures :
  1. To evaluate the safety, improvement in biological parameters and reduction of number of extra-renal flares. [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age>18 years
  • Fulfill at least 4 of the 11 criteria for the ACR classification
  • Any extra-renal flare with an SLEDAI>6 and/or one BILAG A or 2 B
  • Oral corticosteroids>10 mg/day and HCQ > 400 mg/day for at least 30 days prior to inclusion

Exclusion Criteria:

  • Presence of active renal disease
  • Previous intolerance or hypersensibility to any of the active components
  • Active infection
  • Unmeasurable levels of TMPT
  • Pregnancy
  • Presence of a severe flare that requires other immunosuppressive treatment for its control
  • Any Psychiatric or social condition that did not ensure the patient´s follow-up and patient´s collaboration
  • Previous treatment with EC-MPS or Azathioprine in the last 2 months
  • Previous treatment with biological therapy in the last 3 months for anti-TNF therapy or in the last year for anti-CD20 therapy
  • ALT or GPT >120 UI/mL non-lupus related in the last 30 days
  • Leucopenia <1000x10E6 non-lupus related in the last 30 days
  • Symptoms related to other medical conditions non-lupus related such as antiphospholipid syndrome.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112215


Locations
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Spain
Vall d'Hebron Hospital
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
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Study Director: JOSEP ORDI-ROS, MD VALL D'HEBRON HOSPITAL
Principal Investigator: JOSEFINA CORTES HERNANDEZ, MD VALL D'HEBRON HOSPITAL
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT01112215    
Other Study ID Numbers: 2008-008934-35
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: March 2015
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
SLE
non-renal manifestations
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Azathioprine
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
 Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents