Enteric-coated Mycophenolate Sodium Versus Azathioprine for the Extra-renal Lupus Manifestations
This trial is active, not recruiting.
|Condition||systemic lupus erythematosus|
|Treatments||azathioprine, enteric-coated mycophenolate sodium|
|Sponsor||Hospital Universitari Vall d'Hebron Research Institute|
|Start date||December 2009|
|End date||December 2015|
|Trial size||240 participants|
|Trial identifier||NCT01112215, 2008-008934-35|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||crossover assignment|
Obtention of complete remission
time frame: 24 months
To evaluate the safety, improvement in biological parameters and reduction of number of extra-renal flares.
time frame: 24 months
Male or female participants from 18 years up to 65 years old.
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.
|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|
|Principal investigator||JOSEFINA CORTES HERNANDEZ, MD|
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