Enteric-coated Mycophenolate Sodium Versus Azathioprine for

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01112215
Study type	Interventional
Source	Hospital Universitari Vall d'Hebron Research Institute
Contact
Status	Completed
Phase	Phase 4
Start date	December 2009
Completion date	December 2015

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT03843125` - A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)	Phase 3
Recruiting	`NCT05698173` - Systemic Lupus Erythematosus and Accelerated Aging	N/A
Active, not recruiting	`NCT01649765` - Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy	Phase 2
Recruiting	`NCT05704153` - Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A)	N/A
Completed	`NCT05048238` - Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus	Phase 1
Recruiting	`NCT06056778` - The Prevalence Evaluation of Systemic Lupus Erythematosus in Russian Patients With Reproductive Issues (PRISMA)
Completed	`NCT04358302` - Individual Patient Exposure and Response in Pediatric Lupus	N/A
Completed	`NCT03802578` - The Impact of Exercise on Hand Function, Daily Activities Performance and Quality of Life of SLE' Patients	N/A
Completed	`NCT02554019` - Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus	Phase 2
Recruiting	`NCT04835883` - Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus Patients	Phase 2
Terminated	`NCT02665364` - Phase IIb Study of IFN-K in Systemic Lupus Erythematosus	Phase 2
Completed	`NCT00278538` - Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus	Phase 2
Completed	`NCT00069342` - Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases
Completed	`NCT03252587` - An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus	Phase 2
Terminated	`NCT02066311` - Nelfinavir in Systemic Lupus Erythematosus	Phase 2
Recruiting	`NCT01892748` - Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus.	N/A
Terminated	`NCT01689025` - An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)	Phase 1
Completed	`NCT01475149` - Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE)	N/A
Unknown status	`NCT01712529` - Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients	N/A
Completed	`NCT00962832` - A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms