title: EULAR points to consider for conducting clinical trials in systemic lupus erythematosus.
abstract: OBJECTIVE
  Systemic lupus erythematosus (SLE) is a complex multi-organ disease, characterised by relapses and remissions.
  
  
  METHODS
  ng a high-quality randomised controlled trial poses many challenges. We have developed evidenced-based recommendations for points to consider in conducting clinical trials in patients with SLE.
  
  
  METHODS
  The EULAR Task Force on SLE comprised 19 specialists and a clinical epidemiologist. Initially, the evidence for clinical trial end-points in SLE was evaluated and this has been reported separately. A consensus approach was developed by the SLE Task Force in formulating recommendations for points to consider when conducting clinical trials in SLE.
  
  
  RESULTS
  The literature review revealed that most outcome measures used in phase 2/3 trials in SLE have not actually been validated in clinical trials, although other forms of validation have been undertaken. The final recommendations for points to consider for conducting clinical trials in SLE address the following areas: study design, eligibility criteria, outcome measures including adverse events, concomitant therapies for SLE and its complications.
  
  
  CONCLUSIONS
  Recommendations for points to consider when conducting clinical trials in SLE were developed using an evidence-based approach followed by expert consensus. The recommendations should be disseminated, implemented and then reviewed in detail and revised using an evidence-based approach in about 5 years, by which time there will be further evidence to consider from current clinical trials.
authors.affiliation: Rheumatology Research Group, Division of Immunity and Infection, The University of Birmingham, Birmingham, UK. p.c.gordon@bham.ac.uk
authors.forename: C
authors.initials: C
authors.lastname: Gordon
authors.forename: G
authors.initials: G
authors.lastname: Bertsias
authors.forename: J P A
authors.initials: JP
authors.lastname: Ioannidis
authors.forename: J
authors.initials: J
authors.lastname: Boletis
authors.forename: S
authors.initials: S
authors.lastname: Bombardieri
authors.forename: R
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authors.lastname: Cervera
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authors.initials: C
authors.lastname: Dostál
authors.forename: J
authors.initials: J
authors.lastname: Font
authors.forename: I-M
authors.initials: IM
authors.lastname: Gilboe
authors.forename: F
authors.initials: F
authors.lastname: Houssiau
authors.forename: T W J
authors.initials: TW
authors.lastname: Huizinga
authors.forename: D
authors.initials: D
authors.lastname: Isenberg
authors.forename: C G M
authors.initials: CG
authors.lastname: Kallenberg
authors.forename: M A
authors.initials: MA
authors.lastname: Khamashta
authors.forename: J-C
authors.initials: JC
authors.lastname: Piette
authors.forename: M
authors.initials: M
authors.lastname: Schneider
authors.forename: J S
authors.initials: JS
authors.lastname: Smolen
authors.forename: G
authors.initials: G
authors.lastname: Sturfelt
authors.forename: A
authors.initials: A
authors.lastname: Tincani
authors.forename: R
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authors.lastname: Van Vollenhoven
authors.forename: D T
authors.initials: DT
authors.lastname: Boumpas
mesh_terms: D018501:Antirheumatic Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy*; D017063:Outcome Assessment, Health Care / Q000379:methods; D012107:Research Design
chemical_list: D018501:Antirheumatic Agents