Table 1

Eligibility and exclusion criteria

Eligibility Criteria
 Age≥18 years≥18 years
 DiagnosisActive, adult-onset RAActive, adult-onset RA
 Disease duration≥3 months to <2 years6 months to 20 years
 Disease activityDAS28≥3.2, Westergren ESR≥28 mm/h, or CRP≥20 mg/L≥10 swollen and ≥12 painful joints and ≥1 of the following: Westergren ESR≥28 mm/h, CRP≥20 mg/L or morning stiffness for ≥45 min
 Previous treatmentsN/ALess than satisfactory response to previous treatment with ≥1 DMARD other than MTX*
Exclusion Criteria
 Previous treatmentsMTX, ETN or other TNF antagonistETN or other TNF antagonist
Other DMARDs or corticosteroid injections in the 4 weeks before baseline†Other DMARDs or corticosteroid injections in the 4 weeks before baseline
Immunosuppressive drugs within 6 months of screening
Use of any investigational drug or biological within 3 months of screening
  • *Patients previously treated with MTX could be enrolled, providing they had no investigator-defined clinically important toxic effects or lack of response and had not received MTX within 6 months of enrolment.

  • †Stable doses of oral corticosteroids (≤10 mg/day of prednisone or an equivalent agent) or a single non-steroidal anti-inflammatory drug were permitted if started ≥4 weeks before baseline and kept constant throughout the first 24 weeks of the study.

  • COMET, COmbination of Methotrexate and ETanercept in Active Early Rheumatoid Arthritis; CRP, C reactive protein; DAS28, Disease Activity Score in 28 joints; DMARD, disease-modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; ETN, etanercept; MTX, methotrexate; N/A, not applicable; RA, rheumatoid arthritis; TEMPO, Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes; TNF, tumour necrosis factor.