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. 2019 Oct 24;8:212595. doi: 10.7573/dic.212595

Table 2.

Overview of upadacitinib rheumatoid arthritis phase III program.

Study SELECT-Early SELECT-Monotherapy SELECT-Compare SELECT- Next SELECT- Beyond SELECT-Choice
Population MTX-naïve MTX-IR MTX-IR csDMARD-IR bDMARD-IR bDMARD-IR
Type of therapy Mono Mono Combo Combo Combo Combo
Concomitant background MTX csDMARDs csDMARDs csDMARDs
Active comparator MTX MTX ADA ABT
Arms
  1. UPA 15 mg QD

  2. UPA 30 mg QD

  3. MTX

  1. UPA 15 mg QD for 240 weeks

  2. UPA 30 mg QD for 240 weeks

  3. MTX for 14 week followed by UPA 15 mg QD for 226 weeks

  4. MTX for 14 weeks followed by UPA 30 mg QD for 226 weeks

  1. PBO (0–26 weeks), followed by UPA 15 mg QD (27 weeks– 5 years)

  2. ADA EOW for 5 years

  3. UPA 15 mg QD for 5 years

  1. UPA 15 mg QD for 272 weeks

  2. UPA 30 mg QD for 272 weeks

  3. PBO for 12 weeks followed by UPA 15 mg QD for 260 weeks

  4. PBO for 12 weeks followed by UPA 30 mg QD for 260 weeks

  1. UPA 15 mg QD for 240 weeks

  2. UPA 30 mg QD for 240 weeks

  3. PBO for 12 weeks followed by UPA 15 mg QD for 228 weeks

  4. PBO for 12 weeks followed by UPA 30 mg QD for 228 weeks

  1. ABT i.v. EOW (0–20 weeks), followed by UPA (24 weeks– 5 years)

  2. UPA QD for 24 weeks followed by UPA QD for 5 years

Duration Period 1 12 weeks 14 weeks 26 weeks 12 weeks 12 weeks 24 weeks
Actual enrollment 1002 648 1629 661 499 614

ABT, abatacept; ADA, adalimumab; bDMARD, biologic disease-modifying antirheumatic drug; csDMARD, conventional synthetic disease-modifying antirheumatic drug; EOW, every other week; IR, insufficient responder; MTX, methotrexate; PBO, placebo; QD, once daily; UPA, upadacitinib. Study details from https://clinicaltrials.gov