Eligibility and exclusion criteria
| COMET | TEMPO | |
|---|---|---|
| Eligibility Criteria | ||
| Age | ≥18 years | ≥18 years |
| Diagnosis | Active, adult-onset RA | Active, adult-onset RA |
| Disease duration | ≥3 months to <2 years | 6 months to 20 years |
| Disease activity | DAS28≥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 treatments | N/A | Less than satisfactory response to previous treatment with ≥1 DMARD other than MTX* |
| Exclusion Criteria | ||
| Previous treatments | MTX, ETN or other TNF antagonist | ETN 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.