. 2018 Jul 10;58(3):283–297. doi: 10.1007/s40262-018-0695-9

Table 2.

Phase III clinical trials of Cladribine Tablets

Trial name	Study description	Patients and treatment arms^a	ClinicalTrials.gov identifier	References
A safety and efficacy study of oral cladribine in subjects with relapsing–remitting multiple sclerosis (CLARITY)	Randomised, double-blind, 3-arm, placebo-controlled, multicentre study to evaluate the safety and efficacy of oral cladribine in subjects with relapsing–remitting multiple sclerosis	CT 3.5, n = 433^b CT 5.25, n = 456^b PBO, n = 437	NCT00213135	[3]
CLARITY extension	Double-blind, placebo-controlled, multicentre, parallel group, extension trial to evaluate the safety and tolerability of oral cladribine in subjects with relapsing–remitting multiple sclerosis who have completed the CLARITY trial	CT 3.5 → PBO, n = 98 CT 5.25 → PBO, n = 92 CT 3.5 → CT 3.5, n = 186 CT 5.25 → CT 3.5, n = 186 PBO → CT 3.5, n = 244	NCT00641537	[4]
Oral cladribine in early multiple sclerosis (ORACLE-MS)	Randomised, double-blind, clinical trial to assess the safety and efficacy of 2 doses of Cladribine Tablets versus placebo in patients who had a first clinical demyelinating event (clinically isolated syndrome)	CT 3.5, n = 206 CT 5.25, n = 204 PBO, n = 206	NCT00725985	[5]

Trial name

Study description

Patients and treatment arms^a

ClinicalTrials.gov identifier

References

A safety and efficacy study of oral cladribine in subjects with relapsing–remitting multiple sclerosis (CLARITY)

Randomised, double-blind, 3-arm, placebo-controlled, multicentre study to evaluate the safety and efficacy of oral cladribine in subjects with relapsing–remitting multiple sclerosis

CT 3.5, n = 433^b

CT 5.25, n = 456^b

PBO, n = 437

NCT00213135

[3]

CLARITY extension

Double-blind, placebo-controlled, multicentre, parallel group, extension trial to evaluate the safety and tolerability of oral cladribine in subjects with relapsing–remitting multiple sclerosis who have completed the CLARITY trial

CT 3.5 → PBO, n = 98

CT 5.25 → PBO, n = 92

CT 3.5 → CT 3.5, n = 186

CT 5.25 → CT 3.5, n = 186

PBO → CT 3.5, n = 244

NCT00641537

[4]

Oral cladribine in early multiple sclerosis (ORACLE-MS)

Randomised, double-blind, clinical trial to assess the safety and efficacy of 2 doses of Cladribine Tablets versus placebo in patients who had a first clinical demyelinating event (clinically isolated syndrome)

CT 3.5, n = 206

CT 5.25, n = 204

PBO, n = 206

NCT00725985

[5]

CT 3.5 Cladribine Tablets 3.5 mg/kg cumulative dose over 2 years, CT 5.25 Cladribine Tablets 5.25 mg/kg cumulative dose over 2 years, PBO placebo

^aTreatment arms in the CLARITY Extension study are shown as the CLARITY treatment on the left side of the arrow and the CLARITY Extension treatment on the right side of the arrow

^bA subpopulation of 125 patients from the CT 3.5 and CT 5.25 treatment groups in the CLARITY study provided samples for pharmacokinetics analyses, including the population pharmacokinetic analysis by Savic et al. [19]