Table 5.

Additional studies in CD

Clinical study number/name	Study phase	Study details	Status
NCT00160524 PRECiSE 333	Phase 3 extension	7 year, open-label study of patients who completed NCT00152490 (PRECiSE 1) and NCT00152425 (PRECiSE 2).	Ongoing
		400 mg CZP q4w.
NCT00160706 PRECiSE 434	Phase 3 extension	7 year, open-label study of patients who withdrew from NCT00152490 (PRECiSE 1) and NCT00152425 (PRECiSE 2) due to exacerbation of CD.	Ongoing
		400 mg CZP q4w.
NCT00552058	Phase 3	6 wk, double-blind, placebo-controlled study.	Completed
		400 mg CZP or placebo at wks 0, 2 and 4.
		N = 421 adult active CD patients.
		Primary endpoint: % patients in remission at wk 6.
NCT00552344	Phase 3 extension	5 year open-label extension to NCT00552058.	Ongoing
		400 mg CZP q4w.
NCT00308581 WELCOME24	Phase 3b	26 wk, open-label study of patients who had previously failed with infliximab.	Completed
		400 mg CZP at wks 0, 2 and 4, followed by 400 mg CZP q2w or q4w.
		N = 539 adult active CD patients.
		Primary endpoint: Response rate at wk 6 (62% patients achieved CDAI100).
		Secondary endpoint: Comparison of the two maintenance dose regimens (no significant difference between % patients achieving CDAI100 at wk 26, p = 0.55).
NCT00333788	Phase 3 extension	Open-label extension to NCT00308581 (WE LCOME).	Ongoing
NCT00349752 CONCiSE	Phase 3b	36 wk, double-blind, placebo-controlled study to assess the corticosteroid sparing effect of CZP in CD patients.	Completed (prematurely terminated due to slow enrollment)
		Placebo or 400 mg CZP at wks 0, 2 and 4 and then placebo or 400 mg CZP q4w thereafter. Patients followed a corticosteroid forced-taper regimen.
		N = 174 adult CD patients with moderate-to-severe disease.
		Primary endpoint: % patients who remained off corticosteroids are in remission at wk 36.
NCT00356408	Phase 3 extension	Open-label extension to NCT00349752 (CONCiSE)	Ongoing
NCT00297648 MUSIC35	Phase 3b	54 wk open-label study to assess endoscopic mucosal healing in CD patients.	Completed
		400 mg CZP at wks 0, 2 and 4, followed by 400 mg CZP q4w thereafter. Escalated to 400 mg CZP q2w if there has been a loss of response.
		N = 89 adult active CD patients suffering from at least 2 segments with endoscopic ulcerative lesions with baseline CDEI S ≥8.
		Primary endpoint: Change from baseline CDEI S at wk 10 (achieved).
NCT00899678	Phase 2	62 wk, open-label pediatric study.	Ongoing
		Loading:
		Patients 20–40 kg: 200 mg wk 0, 2 and 4
		Patients >40 kg: 400 mg wk 0, 2 and 4
		Treatment arms (wks 6–62):
		High dose:
		Patients 20–40 kg: 200 mg q4w
		Patients >40 kg: 400 mg q4w
		Low dose:
		Patients 20–40 kg: 100 mg q4w
		Patients >40 kg: 200 mg q4w
		N = 160 (estimated) CD patients aged 6–17 years.
		Primary endpoint: % patients in remission at wk 62.
NCT00844285 SECURE	Observational registry	Observational registry for CD patients in the USA.	Ongoing
		N = 4000 CD patients; CZP cohort and non-CZP comparators (estimated).

CZP was administered subcutaneously in all studies. CD, Crohn disease; wk, week; CZP, certolizumab pegol; q2w, every 2 weeks; q4w, every 4 weeks; CDAI, Crohn disease activity index; CDAI100, decrease of at least 100 CDAI points; CDEI S, Crohn Disease Endoscopic Index of Severity.