Study | RA Status | DMARD history | Period 1 designa | Criteria to enter period 2 | Period 2 designa | Primary endpoint |
---|---|---|---|---|---|---|
PRESERVE [17] | Moderate (DAS28 > 3.2 and ≤ 5.1) | MTX 15–25 mg QW for 8 weeks prior to screening; bDMARD naive | 36 weeks: ETN50 + MTX QW | Sustained LDA (mean DAS28 ≤ 3.2) from weeks 12–36 and DAS28 ≤ 3.2 at week 36 | 52 weeks: 1. ETN50 + MTX | % patients in the ETN50 + MTX and PBO + MTX groups achieving DAS28 LDA at week 88.b Conditional primary endpoint was DAS28 LDA at week 88 with ETN25 + MTX |
2. ETN25 + MTX | ||||||
3. PBO + MTX, all QW | ||||||
PRIZE [37] | Moderate-to-severe (DAS28 > 3.2) early RA (symptom onset ≤ 12 months prior to enrollment) | MTX and bDMARD naive | 52 weeks: ETN50 + MTX QW | DAS28 ≤ 3.2 at week 39 and DAS28 < 2.6 at week 52 | 39 weeks: 1. ETN25 + MTX | % patients with sustained remission (DAS28 < 2.6) at weeks 76 and 91 (no corticosteroids from weeks 52 to 64)c |
2. PBO + MTX | ||||||
3. PBO + PBO | ||||||
T2T [36] | Moderate-to-severe | Inadequate response to MTX | 24 weeks: ETN50 + MTX QW ± other csDMARDsd | LDA (DAS28 < 3.2) at week 24 | 28 weeks: 1. ETN50 + MTX ± other csDMARDsd | % patients with DAS28 LDA at week 52 without rescue medication |
 |  |  |  |  | 2. PBO + MTX ± other csDMARDsd |  |