Table 2.

Secondary outcomes following 32 weeks of therapy with methotrexate 25 mg weekly or placebo during the maintenance phase of the study.

	Placebo (n=40)	MTX (n=44)	P value
Mucosal healing at week 48	15 (38%)	13 (30%)	0.36
Relapse between week 16 and week 48	22 (55%)	22 (50%)	0.67
Steroid-free clinical remission or response and FCP levels <250 mg/kg at week 48 in the subgroup of patients with FCP ≥250 mg/kg at screening*	8 (20%)	10 (23%)	0.63
Steroid-free clinical remission or response and FCP levels ≤50 mg/kg at week 48 in the subgroup of patients with FCP ≥250 mg/kg at screening*	3 (8%)	2 (5%)	0.62

^*65 patients (placebo n=32, MTX n=33) at randomization had FCP at screening ≥ 250 mg/kg