This trial is active, not recruiting.

Condition systemic lupus erythematosus
Treatments azathioprine, enteric-coated mycophenolate sodium
Phase phase 4
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
(Active Comparator)
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
Initial dose of 1440 mg/day for 6 months to be tapered progressively if complete remission had been obtained

Primary Outcomes

Obtention of complete remission
time frame: 24 months

Secondary Outcomes

To evaluate the safety, improvement in biological parameters and reduction of number of extra-renal flares.
time frame: 24 months

Eligibility Criteria

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Hospital Universitari Vall d'Hebron Research Institute.