Clinical Trial Search

Primary: Time to Occurrence of Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease Flare During Double-Blind Phase (Period B) — NA; 6 months — p=0.0002

Primary: Time to Response to Treatment, as Determined by a Modified JIA ACR30 Requiring no Fever, Coupled With a Requirement for Corticosteroid Taper in Participants Who Are…

Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 29; 5 participants

Primary: Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16 — 1.6166; 9.2277; 13.8928; 22.9060 ug/ml

Primary: Pain — 4.3; 5.7 units on a scale

Primary: Percent of Patients With a Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30 (ACR30) Flare in Part II of the Study (Weeks 16-40) — 48.1; 25.6…

Primary: Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase — 13; 20 Participants — p=0.031

Primary: Percentage of Participants With Disease Flare in Part 2 — 81; 28 percentage of participants — p=0.0030

Primary: Disease Activity Score Based on 28-joint Disease Activity Score (DAS28) — 4.40; 4.03; 4.57; 4.48 units on a scale

Primary: Number of Participants With Treatment-Related Adverse Events of Etanercept — 22 participants

Primary: Proportion of Participants Who Attain Inactive Disease by 6 Months — 10; 17 participants

Primary: Number of Participants With Malignancy: All Periods of Parent and Extension Study — 1 Participants

Primary: Part I: Percentage of Participants With ≥30% Improvement in Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Core Set and Absence of Fever…

Primary: Composite of All Primary Endpoints — 13; 14; 41; 245 Participants — p=0.7357

Primary: Apparent Oral Clearance (CL/F) — 28.09; 25.48; 20.53 liter per hour

Primary: Number of Subjects Achieving Pediatric American College of Rheumatology 30% (PedACR30) Response at Week 16 — 23 Participants

Primary: Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12 — 88.6 Percentage of participants

Primary: Change From Baseline in DAS28-4/ESR at Week 4 — -1.01 units on a scale — p=< 0.0001

Primary: Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) — 12; 7; 5; 0 participants

Primary: Double Blind Phase: Percentage of Participants With Disease Flare According to Pediatric Rheumatology Collaborative Study Group/Pediatric Rheumatology International…

Primary: Number of Participants With a Two-step Reduction in Inflammation — 5 participants

Primary: Number of Participants With Adverse Events of Special Interest and Study-Drug Related Adverse Events — 6; 0; 1; 1 participants

Primary: Percentage of Participants Experiencing a American College of Rheumatology (ACR) Pediatric 30 Response at Week 16 — 90.0 percentage of participants

Primary: Change in Pain Intensity — 3.56; 3.26; 3.07; 2.90 Units on a scale — p=<.001

Primary: Number of Patients Meeting the Definition of Improvement (DOI) at Week 24: at Least 3 of 6 Core Set Measures (CSM) Improved by ≥ 20% With no More Than 2 CSM Worsening by…

Primary: Serum Trough Concentration (C-trough) of Golimumab — 0.50 micrograms per milliliter (mcg/mL)

Primary: Sleep Disturbance — 62.1; 62.4; 57.7; 58.3 T-score

Primary: Positive Serum GMTs at 7 Months (HPV06) — 34 participants

Primary: Percentage of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 30 Response — 100; 100; 100; 100 Percentage of Participants

Primary: Feasibility as Assessed by Adherence — 12 Participants