Table 1.

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.