Table 3

Radiographic methodology and statistical analysis in each trial

Patients
population
Trial nameScoring methodInterval radiographs*Number of readersInter-/intra reader agreementAssessment of agreementSDC/SDDImpution methodsSensitivity analysis
LELOCFOthers
MTX naïveUS301Sharp0, 1 year, (2 years)10.972, 0.971†--NoNo-Yes‡
MN302Sharp0, 1 year, (2 years)10.972, 0.971†--NoYes-Yes‡
ERASharp0, 6 months, 1 year, (2,4,5 years)2 of 60.85/-ICC-YesNo--
ASPIRESvdH0, 30 weeks, 1 year2--SDD
(0.93 at week 54)
YesNoUnconditional mean imputation§-
PREMIERSharp0, 6 months, 1 year, (2, 5 years)2 of 4----No--
COMETSvdH0, 1 year, 2 years20.935/0.961ICC-YesNo--
GO-BEFORESvdH0, 28 weeks, 1 year, (2, 5 years)2-/0.90ICCSDC
(2.7 at week 52)
YesNo--
IMAGEGenant0, 6 months, 1 year, (2 years)2---YesNo-Yes
OPTIMASvdH0, 26 weeks, 78 weeks2---NoNoMI¶-
AGREEGenant0, 6 months, 1 year, (2 years)----YesNo-Yes
HOPEFUL 1Sharp0, 6 months2---YesNo--
FUNCTIONSvdH0, 6 months, 1 year, (2 years)----YesNo-Yes
PRIZESvdH0**, 39weeks**,65weeks**1---NoYes--
ORAL StartSvdH0, 6 months, 1 year, 2 years2---YesNo-Yes
C-OPERASvdH0, 6 months, 1 year2---YesNo--
C-EARLYSvdH0, 1 year2---YesNo--
RA-BEGINSvdH0, 6 months, 1 year2--SDC (1.15 at week 24, 1.41 at week 52)YesNo-Yes
MTX IRIL-1RAGenant0, 6 months, 1 year1---YesYes-Yes‡
ATTRACTSvdH0, 7 months, 1 year, (2 years)20.89/-ICC-NoNoCMI††Yes
DE-O19Sharp0, 6 months, 1 year, (3, 5 years)2---YesYes-Yes
AIMGenant0, 1 year, (2 years, 5 years)20.9/-ICC-YesNo-Yes
LITHEGenant0, 6 months, 1 year, (2, 5yrears)2---YesNo-Yes
RAPID 1SvdH0, 6 months, 1 year, (2 years)2 of 3---YesYes-Yes
RAPID 2SvdH0, 6 months, (2 years, 3 years)2---YesYes-Yes
GO-FORWARDSvdH0, 6 months, 1 year, (2 years)2-/0.95ICCSDC
(1.8 at 52 week)
YesNo--
GO-FORTHSvdH0, 6 months, (3 years)20.98, 0.80‡‡ICCSDC
(3.23 at 24 week)
NoNo--
CAMEOSvdH0, 1 year, 2 years1-NoYes-Yes
J-RAPIDSvdH0, 6 months2---YesNo--
ACT-RAYGenant0, 6 months, 1 year, (2 years)2--SDC
(1.5 at 52 week)
NoYes-
ORAL-SCANSvdH0, 6 months, 1 year, 2 years2---YesNoGEE, RCMYes
GO-FURTHERSvdH0, 6 months, 1 year, (2 years)20.76/0.97ICCSDC
(1.91 at 52 week)
YesYes-Yes
AMPLESvdH0, 1 year2-ICCSDC
(2.8 at 52 week)
YesNo--
DRIVESvdH0, 6 months, 1 year----YesNo--
PLANETRASvdH0, 1 year2---YesNo--
MOBILITYSvdH0, 6 months, 1 year, (2 years)2---YesYes-Yes
RA-BEAMSvdH0, 6 months, 1 year2--SDC (1.22 at 24 week)
(1.47 at 52 week)
YesYesMMRMYes
SB4SvdH0, 1 year2--SDC
(2.3 at 52 week)
NoNo--
SB2SvdH0, 1 year2---NoNo--
RAJ4SvdH0, 6 months, 1 year2---YesNo-Yes
SELECT-COMPARESvdH0, 3 months, 6 months2---YesNo-Yes
DMARD IRMN301Sharp0, 6 months, 1 year, (2 years)1---NoYes-Yes‡
TEMPOSvdH0, 6 months, 1 year, (2, 3 years)20.85–0.98/0.90–0.99ICCSDD
(6.2 at 52 week)
YesYes-Yes‡
SAMURAISvdH0, 6 months, 1 year20.96–0.98/0.99ICC-YesNo--
GO-MONOSvdH0, 6 months, (52, 104, 120 weeks)20.98, 0.80/ICC-NoNoMedian change§§-
HIKARISvdH0, 6 months, 1 year2---YesNo--
J-ETASvdH0, 6 months, 1 year2--SDDYesNo--
BREVACTASvdH0, 6 months, 72 weeks----YesNo-Yes
SURROUND-DSvdH0, 18 weeks, 6 months, 1 year----YesNo--
RA-BUILDSvdH0, 6 months2--SDC
(1.2 at 24 week)
YesYes--
TNFi IRREFLEXGenant0, 6 months, 1 year, (2, 5 years)2---YesNo-Yes
ADMIRESvdH0, 28 weeks, 1 year----NoNo--
REASSURESvdH0, 1 year, (2 years)----NoNoMMRM-
  • *Values in parentheses meant X-ray intervals during the long-term extension period.

  • †Values were correlation coefficients between the duplicate readings of baseline and year-1 radiographs when these were reread along with the year-2 films (correlation coefficient 0.971 for year-1 films and 0.972 for baseline films).

  • ‡Sensitivity analysis was not performed in the primary analysis.

  • §Missing data was imputed using the change from baseline was estimated using the percentile of the entire patient population.

  • ¶The Markov Chain Monte Carlo method was used to impute the missing radiographic data.

  • **Radiographs were obtained at baseline (1 year in the open-label phase), 39 weeks (91 weeks in the open-label phase) in the double-blind period.

  • ††Missing data was imputed using group mean change.

  • ‡‡ICC at baseline and week 24 was 0.98 and 0.80, respectively.

  • §§Changes from baseline in SvdH score for these patients were substituted with the median change for all patients.

  • CMI, Conditional mean imputation; DMARDs, disease-modifying antirheumatic drugs; GEE, generalised estimating equation; ICC, intra-class correlation coefficient; IR, inadequate responder; LE, linear extrapolation; LOCF, last observation carried forward method; MI, multiple imputation; MMRM, mixed model for repeated measures; RCM, Random coefficients model; SDC, smallest detectable change; SDD, smallest detectable difference; SvdH, van der Heijde modification of the Sharp score; TNF, tumour necrosis factor.