| Interventions |
Investigational Products: Adalimumab Mode of administration: Subcutaneous injection (SC) Induction Study: Double-Blind Induction: Subjects will be randomized to receive one of 2 double-blind adalimumab induction dosing regimens. Doses: Standard Induction Dose Regimen: 160 mg at Week 0 and matching placebo at Week 1. Subjects will receive 80 mg at Week 2 and matching placebo at Week 3. Subjects will receive 40 mg at Week 4 and Week 6. Higher Induction Dose Regimen: 160 mg at Weeks 0, 1, 2, and 3. Subjects will receive 40 mg at Week 4 and Week 6. Maintenance Study: Double-Blind Maintenance Doses: Subjects will be re-randomized to receive one of 3 double-blind adalimumab maintenance dosing regimens. Adalimumab 40 mg eow Regimen: 40 mg every other week, starting at Week 8 until Week 50. Matching Placebo will be administered every other week, starting at Week 9 until Week 51. No dose will be administered at Week 52. Adalimumab 40 mg ew Regimen: 40 mg every week, starting at Week 8 until Week 51. No dose will be administered at Week 52. Adalimumab TDM Regimen: 40 mg eow at Week 8 and Week 10. Matching placebo at Week 9 and Week 11. At Weeks 12, 24 and 37, the regimen will be adjusted for subjects meeting specified criteria. Subjects receiving 40 mg eow and meeting the regimen adjustment criteria will escalate to 40 mg weekly. Subjects receiving 40 mg ew and meeting the regimen adjustment criteria will receive a one-time dose of 160 mg at the visit, followed by 40 mg ew starting the following week. Subjects receiving 40 mg eow who do not meet the regimen adjustment criteria will receive adalimumab 40 mg eow and placebo at alternative weeks. |