Table 1.
Characteristics of patients included in the analysis at entry into CLARITY extension.
| CP3.5 mg/kg | CC7.0 mg/kg | |
|---|---|---|
| All patients (n = 98) | All patients (n = 186) | |
| Age, years | 40.7 (10.7) | 40.6 (10.5) |
| Female, n (%) | 67 (68.4) | 124 (66.7) |
| Disease duration, a years | 10.1 (6.7) | 10.4 (7.1) |
| Number of T1 Gd+ lesions | 0.27 (0.96) | 0.31 (1.56) |
| T2 lesion volume (103 mm3) | 18.6 (19.1) | 13.7 (14.4) |
| Median EDSS score (min; max) | 2.5 (0; 6.5) | 2.5 (0; 6.5) |
| Prior use of DMT at any time, n (%) | 18 (18.4) | 43 (23.1) |
| DMT use between CLARITY and CLARITY Extension, n (%) | 2 (2.0) | 0 (0) |
| DMT use in 3 months prior to CLARITY Extension, n (%) | 0 (0) | 0 (0) |
| Relapse between CLARITY and CLARITY Extension, n (%) | 9 (9.2) | 17 (9.1) |
| Median interval between studies (min; max), b weeks | 41.3 (0.1; 116.0) | 41.4 (0.4; 115.3) |
SD: standard deviation; EDSS: Expanded Disability Status Scale; DMT: disease-modifying therapy.
Data are mean (SD), unless otherwise stated.
a
Time from first attack to CLARITY Extension Study Day 1.
b
Duration of the gap between the last visit date in the CLARITY treatment period and the randomization date in CLARITY Extension.
CC7.0, patients randomized to cladribine tablets 3.5 mg/kg in both CLARITY and CLARITY Extension; CP3.5, patients randomized to cladribine tablets 3.5 mg/kg in CLARITY and placebo in CLARITY Extension; DMT, disease-modifying therapy; EDSS, Expanded Disability Status Scale; Gd+, gadolinium enhanced.