This study is designed to assess the safety, pharmacokinetics (PK), and biomarker effects of PTC844 compared to placebo in participants with active rheumatoid arthritis (RA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
75
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline up to Week 16
Change From Baseline to Week 2 in Dihydroorotate (DHO)
Time frame: Baseline, Week 2
Change From Baseline to Week 12 in C-reactive Protein (CRP)
Time frame: Baseline, Week 12
Change From Baseline to Week 12 in Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline, Week 12
Change From Baseline in DHO Over Time
Time frame: Baseline up to Week 16
Maximum Observed Plasma Concentration (Cmax) of PTC844
Time frame: Baseline up to Week 16
Area Under the Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast)
Time frame: Baseline up to Week 16
Time to Reach Cmax (Tmax)
Time frame: Baseline up to Week 16
Number of Participants Achieving ≥20% Improvement in American College of Rheumatology Score (ACR20)
Time frame: Week 12
Number of Participants Achieving ≥50% Improvement in American College of Rheumatology Score (ACR50)
Time frame: Week 12
Number of Participants Achieving ≥70% Improvement in American College of Rheumatology Score (ACR70)
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Time frame: Week 12
Change From Baseline to Week 12 in 28-Joint Disease Activity Score-CRP (DAS28-CRP)
Time frame: Baseline, Week 12
Change From Baseline to Week 12 in 28-Joint Disease Activity Score-ESR (DAS28-ESR)
Time frame: Baseline, Week 12
Change From Baseline to Week 12 in 20- Item Disability Scale and Heath Assessment Questionnaire (HAQ-DI)
Time frame: Baseline, Week 12