Table 1 |
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Randomized controlled trials of disease-modifying antirheumatic drugs approved since 1998 that have supported regulatory labeling |
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|
Trial |
Year published |
Study drug |
Mean disease duration at BL |
Prior therapy |
Duration |
|
|
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|
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 |
|
|
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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. |
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Strand and Sokolove Arthritis Research & Therapy 2009 11:205 doi:10.1186/ar2555 |
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