Table 1

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

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


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.

Strand and Sokolove Arthritis Research & Therapy 2009 11:205   doi:10.1186/ar2555