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Table 1 Randomized controlled trials of disease-modifying antirheumatic drugs approved since 1998 that have supported regulatory labeling

From: Randomized controlled trial design in rheumatoid arthritis: the past decade

Trial Year published Study drug Mean disease duration at BL Prior therapy Duration
US 301 [5] 1999 LEF vs. MTX vs. PL 7.0 (± 8.6) MTX-naïve 2 years
MN 301 [16] 1999 LEF vs. SSZ vs. PL 7.8 (± 8.6) SSZ-naïve 6 months + continuation
ETN Phase 3 [4] 1999 ETN vs. PL 12a DMARD failures 6 months
ETN+MTX [3] 1999 ETN+MTX vs. PL+MTX 13a MTX > 6 months 6 months (primary at 3)
ATTRACT [6] 1999 INF+MTX vs. MTX+PL 8.4 (± 7.7) MTX > 3 months 2 years
MN 302 [15] 2000 LEF vs. MTX 3.7 (± 3.2) MTX-naïve 1 year + continuation
ERA [12] 2000 ETN vs. MTX 0.9 (± 0.8) MTX-naïve 2 years
TEMPO [13] 2004 ETN vs. MTX vs. ETN+MTX 6.8 (± 5.5) TNF-naïve 2 years
ASPIRE [10] 2004 INF vs. MTX vs. INF+MTX 0.9 (± 0.8) MTX-naïve 1 year
PREMIER [11] 2006 ADA vs. MTX vs. ADA+MTX 0.7 (± 0.8) MTX-naïve 2 years
ATTAIN [20] 2005 ABA+MTX vs. MTX+PL 12.0 (± 8.5) MTX > 3 months, TNF-I failure 6 months + continuation
AIM [19] 2006 ABA+MTX vs. MTX+PL 8.5 (± 7.3) MTX > 3 months, TNF-I-naïve 6 months + continuation
REFLEX [21] 2006 RTX+MTX vs. MTX+PL 11.7 (± 7.7) MTX > 3 months, TNF-I failure 6 months + continuation
DANCER [22] 2006 RTX+MTX vs. MTX+PL 10.5a MTX > 3 months, TNF-I-naïve 6 months + continuation
  1. The table notes mean duration of disease at baseline, background, and/or failed disease-modifying antirheumatic drug (DMARD) therapy at entry and length of study. aStandard deviation not reported. ABA, abatacept; ADA, adalimumab; AIM, Abatacept in Inadequate Responders to Methotrexate; ATTAIN, Abatacept Trial in Treatment of Anti-Tumor Necrosis Factor Inadequate Responders; BL, baseline; DANCER, Dose-Ranging Assessment International Clinical Evaluation of Rituximab in Rheumatoid Arthritis; ETN, etanercept; INF, infliximab; LEF, leflunomide; MTX, methotrexate; PL, placebo; REFLEX, Randomized Evaluation of Long-Term Efficacy of Rituximab; RTX, rituximab; SSZ, sulfasalazine; TNF = I, tumor necrosis factor inhibitor.