Table 1.
Overview of the MEASURE Clinical Trial Program
| Clinical Trial | Length | Start Date | Dosage | Proportion of Anti-TNF-Naïve Patients | Time Since Diagnosis (Overall Population), Mean Years ± SD | Primary Outcome | Notes |
|---|---|---|---|---|---|---|---|
| MEASURE 115 | 2-year study with a 3-year extension | October 2011 | SC 75 mg or 150 mg q4w with IV loading doses (10 mg/kg) | 150 mg 74% (n/N=92/125) and PBO 73% (n/N=89/122) | 150 mg 6.5 ± 6.9 and PBO 8.3 ± 8.9 | Proportion of patients who met ASAS20 response criteria at Week 16 |
IV loading dose not currently licensed |
| MEASURE 215 | 5-year study | October 2012 | SC 75 mg or 150 mg q4w with SC loading doses | 150 mg 61% (N=44/72) and PBO 61% (N=45/74) | 150 mg 7.0 ± 8.2 and PBO 6.4 ± 8.9 | Proportion of patients who met ASAS20 response criteria at Week 16 |
|
| MEASURE 2J19 | 1-year study | March 2016 | SC 150 mg q4w with SC loading doses (doses provided in 1.0 mL PFS) | 150 mg 73.3% (n/N=22/30) | 150 mg 4.6 ± 7.7 | Proportion of patients who met ASAS20 response criteria at Week 16 |
Japanese patients |
| MEASURE 316 | 3-year study | January 2014 | SC 150 mg or 300 mg q4w with IV loading doses (10 mg/kg) | 300 mg 75.0% (n/N=57/76), 150 mg 77.0% (n/N=57/74) and PBO 77.6% (n/N=59/76) | 300 mg 5.3 ± 7.3, 150 mg 6.0 ± 7.2 and PBO 5.2 ± 6.4 | Proportion of patients who met ASAS20 response criteria at Week 16 |
IV loading dose not currently licensed |
| MEASURE 417 | 2-year study | May 2015 | Self-administered SC 150 mg q4w with and without SC loading doses | 150 mg 73.3% (n/N=85/116) and PBO 70.9% (n/N=83/117) | 150 mg 8.4 ± 10.84 and PBO 7.1 ± 9.23 | Proportion of patients who met ASAS20 response criteria at Week 16 |
|
| MEASURE 518 | 1-year study | October 2016 | SC 150 mg q4w with SC loading doses | 150 mg 78.7% (n/N=240/305) and PBO 79.7% (n/N=122/153) | 150 mg 5.7 ± 6.4 and PBO 5.3 ± 6.0 | Proportion of patients who met ASAS20 response criteria at Week 16 |
China-centric |
Abbreviations: IV, intravenous; n, number of anti-TNF-naïve patients in assigned treatment group; N, total number of patients in assigned treatment group; PBO, placebo; PFS, pre-filled syringe; q4w, every 4 weeks; SC, subcutaneous; SD, standard deviation; TNF, tumor necrosis factor.