. 2010 Mar-Apr;2(2):137–147. doi: 10.4161/mabs.2.2.11271

Table 4.

Major phase 3 studies in CD: PRECiSE 1 and PRECiSE 2

PRECiSE 1 (NCT00152490)²² Phase 3 trial: Moderate-to-severe CD patients (n = 662)
SC CZP (400 mg) or placebo at weeks 0, 2 and 4 and then every 4 weeks for 26 weeks. Completers entered PRECiSE 3 and withdrawers entered PRECiSE 4 ongoing open-label studies of 7-years duration.
Endpoints		Placebo	CZP 400 mg
Co-primary	CDAI100 response wk 6 (baseline CRP ≥10 mg/L)	26% (n = 154)	37% (p = 0.04) (n = 145)
Co-primary	CDAI100 response wk 6 and wk 26 (baseline CRP ≥10 mg/L)	12% (n = 154)	22% (p = 0.05) (n = 144)
Selected Secondary	Remission (CDAI ≤150) wk 6 (baseline CRP ≥10 mg/L)	17% (n = 154)	22% (p = NS) (n = 146)
Selected Secondary	Remission (CDAI ≤150) wk 6 and wk 26 (baseline CRP ≥10 mg/L)	8% (n = 154)	13% (p = NS) (n = 145)
PRECiSE 2 (NCT00152425)²³Phase 3 trial: Moderate-to-severe CD patients (n = 668, responders at week 6 = 428)
Induction therapy: SC CZP (400 mg) at weeks 0, 2 and 4. Responders at week 6 (n = 428) then received placebo or CZP (400 mg) SC every 4 weeks to week 26. Completers entered PRECiSE 3 and withdrawers entered PRECiSE 4 ongoing open-label studies of 7-years duration.
Endpoints at week 26		Placebo	CZP 400 mg
Primary	CDAI100 response (baseline CRP ≥10 mg/L)	34% (n = 101)	62% (p < 0.001) (n = 112)
Selected Secondary	CDAI100 response (all patients)	36% (n = 210)	63% (p < 0.001) (n = 215)
Selected Secondary	Remission (CDAI ≤150) (all patients)	29% (n = 210)	48% (p < 0.001) (n = 215)

CD, Crohn disease; SC, subcutaneous; CZP, certolizumab pegol; CDAI, Crohn disease activity index; CDAI100, decrease of at least 100 CDAI points; wk, week; CRP, C-reactive protein; NS, not significant.