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Table 1 Study designs for PRESERVE, PRIZE, and T2T

From: The effect of deep or sustained remission on maintenance of remission after dose reduction or withdrawal of etanercept in patients with rheumatoid arthritis

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  
  1. bDMARD biologic disease-modifying antirheumatic drug, csDMARD conventional synthetic DMARD, DAS28 Disease Activity Score 28-joint count, ETN etanercept, LDA low disease activity, MTX methotrexate, PBO placebo, QW weekly, RA rheumatoid arthritis, T2T Treat-to-Target
  2. aFor all studies, period 1 was open-label induction and period 2 was double-blind maintenance or withdrawal
  3. bA modified nonresponder imputation analysis was conducted: patients who discontinued due to lack of efficacy were treated as nonresponders
  4. cAll patients who discontinued were considered nonresponders
  5. dSulfasalazine, hydroxychloroquine, and leflunomide