Safety and Efficacy of Etanercept (Recombinant Human Tumor Necrosis Factor Receptor Fusion Protein [TNFR:Fc]) in Children With Juvenile Rheumatoid Arthritis (JRA)

NCT03780959 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 20021616016.0016
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study was to determine the efficacy of etanercept in children with polyarticular course JRA.

Conditions

Juvenile Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Disease Flare in Part 2

  Disease flare was defined as a 30% or greater worsening in three of the six JRA Core Set Criteria and ≥ 30% improvement in one or less of the six JRA Core Set Criteria compared to day 90 and a minimum of two active joints (joints with swelling or limitation of movement plus pain and/or tenderness). The JRA Core Set criteria consisted of: * Physician global assessment of disease severity assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms); * Patient/parent global assessment of overall well-being assesses on a VAS from 0 (asymptomatic) to 10 (severe symptoms); * Number of active joints; * Number of joints with limitation of motion (LOM) and with pain, tenderness, or both; * Childhood Health Assessment Questionnaire (CHAQ) disability domain; * Erythrocyte sedimentation rate (ESR).

  End of part 1 (day 90) and months 4 to 7

Secondary Outcomes (2)

• Time to Flare in Part 2

  Months 4 to 7

• Number of Participants With Adverse Events

  Part 1: 90 days (months 1-3) plus 30 days for participants who were not randomized into part 2. Part 2: From first dose of randomized treatment to 30 days after last dose (150 days; months 4-8).

Study Arms (2)

Etanercept/Placebo

PLACEBO COMPARATOR

Participants received 0.4 mg/kg etanercept twice weekly for 90 days during Part 1. In Part 2 participants were randomized to receive placebo subcutaneous injection twice weekly for up to 4 months.

Drug: Etanercept; Drug: Placebo

Etanercept/Etanercept

EXPERIMENTAL

Participants received 0.4 mg/kg etanercept twice weekly for 90 days during Part 1. In Part 2 participants were randomized to continue receiving etanercept twice weekly for up to 4 additional months.

Drug: Etanercept

Interventions

Etanercept DRUG

Administered twice weekly by subcutaneous injection

Also known as: Enbrel, TNFR:Fc

Etanercept/Etanercept; Etanercept/Placebo

Placebo DRUG

Administered twice weekly by subcutaneous injection

Etanercept/Placebo

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of JRA by the American College of Rheumatology (ACR) criteria.
• Disease course must be polyarticular with disease duration long enough to have been given an adequate trial of non-steroidal anti-inflammatory drugs (NSAIDs) and low-dose methotrexate at a dose of at least 10 mg/m²/week
• Continuing active disease, defined as ≥ 5 swollen joints and ≥ 3 joints with limitation of motion accompanied by pain, tenderness or warmth.
• Disease refractory to methotrexate or intolerant of methotrexate.
• Have not received disease-modifying anti-rheumatic drugs (DMARDs) within 28 days prior to enrollment.
• Have not received methotrexate within 14 days prior to dosing of study drug.

You may not qualify if:

• Pregnant or nursing female
• Functional class IV by ACR criteria
• Unable to meet concomitant medication restrictions
• Intraarticular corticosteroid injection within 4 weeks prior to enrollment
• Clinically significant deviations from normal, defined as:
• thrombocytopenia; platelet count \< 100,000/cmm
• leukopenia; total white cell count \< 4000 cells/cmm
• neutropenia; neutrophils \< 1000 cells/cmm
• hepatic transaminase levels \> two times the upper limit of normal (ULN)
• serum bilirubin \> 2 times ULN
• creatinine clearance \< 90 mL/min/1.73 m² body surface area (BSA) and/or a glomerular filtration rate (GFR) \< 90 mL/min/1.73 m² BSA.
• known human immunodeficiency virus (HIV), hepatitis B surface antigen positivity, or hepatitis C positivity.
• anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies or anti-cardiolipin antibodies present.
• Previously received antibody to TNF, antibody to cluster of differentiation (CD)4, or diphtheria interleukin (IL)-2-fusion protein (DAB-IL-2)
• Participated in a study of an investigational drug or biologic requiring informed consent within 3 months prior to study entry.

Sponsors & Collaborators

• Amgen: lead

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 19, 2018
• Study Start: May 1, 1997
• Primary Completion: July 8, 1998
• Study Completion: July 8, 1998
• Last Updated: August 2, 2019
• Results First Posted: August 2, 2019

Record last verified: 2019-06