A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs

Conditions

• Rheumatoid Arthritis (RA)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Abatacept — DRUG
  IV infusion
• Placebo for abatacept (0.9% Sodium Chloride Injection or Solution for Infusion) — DRUG
  IV infusion
• Upadacitinib — DRUG
  15 mg extended release tablet
• Placebo for upadacitinib — DRUG
  Film-coated tablet

Study Details

The study objective of Period 1 was to compare the safety and efficacy of upadacitinib 15 mg once daily (QD) to abatacept on a background of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in biologic disease-modifying antirheumatic drug (bDMARD)-inadequate response or bDMARD-intolerant participants with moderately to severely active RA. The study objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD in participants with RA who had completed Period 1.

Key Dates

Start date

May 9, 2017

Status verified

Jul 2024

Primary completion

Jun 13, 2019

Completion

Jun 6, 2023

Study Design

Enrollment

657 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Primary Cohort: Abatacept/Upadacitinib 15 mg QD
  Period 1: 500 mg (for body weight \<60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight \>100 kg) IV infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20. Period 2: open label upadacitinib 15 mg QD for 192 weeks.
• Experimental: Primary Cohort: Upadacitinib 15 mg QD/Upadacitinib 15 mg QD
  Period 1: One 15 mg upadacitinib oral tablet QD for 24 weeks. Period 2: open label upadacitinib 15 mg QD for 192 weeks.
• Experimental: 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD
  Period 1: One upadacitinib 30 mg oral tablet QD for 24 weeks. Period 2: open label upadacitinib 30 mg (reduced to 15 mg per Amendment 5) QD for 192 weeks.
• Active Comparator: 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD
  Period 1: 500 mg (for body weight \<60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight \>100 kg) IV infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20. Period 2: open label upadacitinib 30 mg (reduced to 15 mg per Amendment 5) QD for 192 weeks.

Primary Outcome Measure

Change From Baseline in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Non-inferiority) [ Time Frame: Baseline and Week 12 ]

Locations (44)

Find similar trials in Peoria, AZ

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