Enteric-coated Mycophenolate Sodium Versus Azathioprine for the Extra-renal Lupus Manifestations
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Registration Number
- NCT01112215
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Enteric-coated Mycophenolate Sodium Enteric-Coated Mycophenolate Sodium - azathioprine Azathioprine -
- Primary Outcome Measures
Name Time Method Obtention of complete remission 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
Name Time Method To evaluate the safety, improvement in biological parameters and reduction of number of extra-renal flares. 24 months
Trial Locations
- Locations (1)
Vall d'Hebron Hospital
🇪🇸Barcelona, Spain