Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis

NCT00078806 | Terminated Phase 3 Results

• 1 other identifier: 20021631
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study was to determine the efficacy of etanercept in pediatric patients with systemically active system onset juvenile rheumatoid arthritis (SOJRA).

Conditions

Juvenile Rheumatoid Arthritis

Keywords

Systemic Onset Juvenile Rheumatoid Arthritis; SOJRA; Fever; Rash; Joint Pain

Outcome Measures

Primary Outcomes (1)

• Number of Participants in Part 2 With Disease Flare

  Disease flare was defined as the presence of: * 1 major flare criterion plus 1 minor flare criterion or 1 lab criterion, OR * 2 minor flare criteria plus 2 lab criteria Major Criteria: * Fever of SOJRA, defined as a spike in axillary temperature ≥ 100°F (38°C) for ≥ 2 days per week in the prior 2 weeks or 8 days during the prior month * Symptomatic serositis documented by x-ray or other imaging modality Minor Flare Criteria * Rash of SOJRA, documented in the daily diary * Splenomegaly defined as spleen palpable \> 2 cm below the left costal margin * Lymphadenopathy defined as ≥ 1 cm in \> 1 node area * Arthritis defined as ≥ 2 active joints with swelling not due to deformity, or if swelling is absent, then 2 joints with loss of motion with pain on passive motion and/or warmth. Laboratory Criteria: All labs should be outside the normal range and with 30% worsening: * Albumin * Platelet count * Hemoglobin * C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR)

  3 months during Part 2 (depending on the timing of response, entry into Part 2 was between study months 3 and 10)

Secondary Outcomes (14)

• Number of Participants With Adverse Events

  Part 1A, maximum duration on treatment was 207 days; Part 1B, maximum duration on treatment was 120 days; Part 2, maximum duration on treatment was 88 days; Part 3, maximum duration on treatment was 130 days; plus 30 days after last dose of study drug.

• Time to Flare in Part 2

  From first dose in Part 1 to the end of Part 2 (up to 13 months)

• Change From Baseline in Physician Global Assessment of Disease Severity in Part 1

  Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9

• Change From Baseline in Physician Global Assessment of Disease Severity in Part 2

  Baseline and months 5, 6, 7, 8, and 9

• Change From Baseline in Patient's/Parent's Global Assessment in Part 1

  Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9

Study Arms (4)

Part 1: Etanercept

EXPERIMENTAL

Participants received 0.4 mg/kg etanercept administered subcutaneously twice a week for up to 6 months in Part 1A. Participants who had a partial response entered Part 1B and received 0.8 mg/kg etanercept twice weekly for up to 4 months.

Drug: Etanercept

Part 2: Placebo

PLACEBO COMPARATOR

Participants who met response criteria in Part 1 were randomized to receive placebo twice a week for up to 3 months.

Drug: Placebo

Part 2: Etanercept

EXPERIMENTAL

Participants who met response criteria in Part 1 were randomized to continue receiving etanercept twice a week at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to 3 months.

Drug: Etanercept

Part 3:

EXPERIMENTAL

Participants who experienced a flare or completed 3 months of treatment in Part 2 entered Part 3 and received open-label treatment with etanercept at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to a maximum of 12 months, including treatment in Part 2.

Drug: Etanercept

Interventions

Etanercept DRUG

Administered by subcutaneous injection twice a week

Also known as: Enbrel

Part 1: Etanercept; Part 2: Etanercept; Part 3:

Placebo DRUG

Administered by subcutaneous injection twice a week

Part 2: Placebo

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years of age
• SOJRA for at least 3 months, with stable systemic features
• If taking methotrexate, hydroxychloroquine, or NSAIDs, dose must be stable
• Must take prednisone at a stable dose

You may not qualify if:

• Need for other DMARDs or prestudy requirements for oral or parenteral pulse steroids or intra-articular steroids
• Pregnant or nursing female
• Clinically significant abnormal laboratory test results for blood cells, liver or kidney function, or serology
• Previous receipt of any tumor necrosis factor (TNF) inhibitor
• Live virus vaccine within 12 weeks of study entry
• Participation in another study requiring informed consent within 12 weeks of entry
• Diabetes that requires insulin treatment
• Infection, chronic, recurrent, or currently active
• Any serious medical or psychiatric condition or history of alcohol or drug abuse

Sponsors & Collaborators

• Amgen: lead
• Immunex Corporation: collaborator

Related Links

• AmgenTrials clinical trials website
• Notice regarding posted summaries of trial results
• To access clinical trial results information click on this link
• FDA-approved Drug Labeling

MeSH Terms

Conditions

Arthritis, Juvenile; Fever; Exanthema; Arthralgia

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; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases; Pain; Neurologic Manifestations

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.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2004
• First Posted: March 9, 2004
• Study Start: June 4, 2001
• Primary Completion: May 6, 2004
• Study Completion: May 6, 2004
• Last Updated: September 25, 2019
• Results First Posted: September 25, 2019

Record last verified: 2019-08