EULAR points to consider for conducting clinical trials in systemic lupus erythematosus.
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.
Gordon
C
C
Rheumatology Research Group, Division of Immunity and Infection, The University of Birmingham, Birmingham, UK. p.c.gordon@bham.ac.uk
Bertsias
G
G
Ioannidis
J P A
JP
Boletis
J
J
Bombardieri
S
S
Cervera
R
R
Dostál
C
C
Font
J
J
Gilboe
I-M
IM
Houssiau
F
F
Huizinga
T W J
TW
Isenberg
D
D
Kallenberg
C G M
CG
Khamashta
M A
MA
Piette
J-C
JC
Schneider
M
M
Smolen
J S
JS
Sturfelt
G
G
Tincani
A
A
Van Vollenhoven
R
R
Boumpas
D T
DT
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
D018501:Antirheumatic Agents