Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trials

This study has been completed.
Sponsor:
Collaborator:
Immunex Corporation
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00357903
First received: July 26, 2006
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

This study was designed to provide all adult and pediatric arthritis patients (placebo and etanercept(TNFR:Fc) treated) who have participated in clinical trials with etanercept (TNFR:Fc) the opportunity to receive continued treatment with etanercept (TNFR:Fc). The primary objective of this study is to examine safety parameters.


Condition Intervention Phase
Rheumatoid Arthritis
Biological: Etanercept
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Extension Treatment With Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) for Participating Patients in Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) Clinical Trials

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Total Exposure to Etanercept With Gaps [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Total participant exposure to etanercept (Enbrel) with gaps

  • Total Exposure Adjusted Rate of Malignancies [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
    Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept

  • Total Exposure Adjusted Rate of Deaths [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
    Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept

  • Total Exposure Adjusted Rate of Serious Infectious Events [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
    Exposure-adjusted rate of serious infectious events (associated with hospitalization or IV antibiotics) occurring on study within 30 days of the last dose of etanercept

  • Total Exposure Adjusted Rate of Lymphomas [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
    Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept

  • Malignancy [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
    Occurrence of one or more malignancies on study within 30 days of the last dose of etanercept

  • Lymphoma [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
    Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept

  • Serious Infectious Event [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
    Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication. A serious infectious event is a serious adverse event that is infectious.

  • Death [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
    Occurrence of death on study within 30 days of the last dose of etanercept

  • Total Exposure Adjusted Rate of Serious Adverse Events [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
    Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100)


Secondary Outcome Measures:
  • Dosing Period [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Duration of etanercept dosing

  • Tender Joint Count [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Number of tender joints, as assessed by the investigator using criteria based on pressure and joint manipulation

  • Swollen Joint Count [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Number of swollen joints

  • Health Assessment Questionnaire Disability Index [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Health Assessment Questionnaire Disability Index (HAQ DI). This index is a weighted average of 24 items, each scored 0 (no difficulty) to 3 (unable to function).

  • Childhood Health Assessment Questionnaire [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Childhood Health Assessment Questionnaire (CHAQ) disability index, having a range of 0 (no difficulty) to 3 (unable to do).

  • C-Reactive Protein [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    C-reactive protein at month 12

  • ACR20 at Month 3 in Adults [ Time Frame: Baseline and month 3 ] [ Designated as safety issue: No ]
    American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (including physician and patient global assessments), in adults

  • JRA DOI 30 at Month 3 in Juveniles [ Time Frame: Baseline and month 3 ] [ Designated as safety issue: No ]
    Juvenile Rheumatoid Arthritis Definition of Improvement 30 (JRA DOI 30), defined as a 30% improvement from baseline in 3 of 6 items (including Childhood Health Assessment Questionnaire, disease severity, overall well-being, and erythrocyte sedimentation rate) and a worsening of >30% in at most one of the remaining items.

  • Standardized Incidence Rate for All SEER Cancers [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
    Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system.


Enrollment: 639
Study Start Date: April 1997
Study Completion Date: April 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
N/A
Biological: Etanercept
Adult Rheumatoid Arthritis (RA) patients on etanercept (TNFR:Fc) with well controlled arthritic symptoms will continue on the etanercept (TNFR:Fc) dose administered in their original protocol of enrollment. All other adults will receive 50 mg per week as two 25 mg subcutaneous (SC) injections at separate sites, either on the same day or 3 or 4 days apart. Pediatric patients ages 4 to 17 years will receive a 0.8 mg/kg per week dose (up to a maximum of 50 mg per week).

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previous enrollment in Immunex protocols
  • No clinically significant adverse events thought to be due to etanercept (TNFR:Fc) during previous treatment.
  • Negative serum pregnancy test not more than 14 days before the first dose of study drug in females of childbearing potential.
  • No more than one NSAID at a dose not greater than the maximum recommended dose and stable for at least two weeks prior to administration of etanercept (TNFR:Fc). Exclusion Criteria: - Previous receipt of TNFR:Fc (p55), antibody to TNF, anti-CD4 antibody, or diphtheria IL-2 fusion protein.
  • Receipt of investigational drugs or biologics (other than TNFR:Fc [p75]) within 1 month prior to the first dose of etanercept (TNFR:Fc) in this study.
  • Receipt of DMARDs or methotrexate (except patients from 16.0014) within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study.
  • Receipt of cyclophosphamide within six months prior to the first dose of (etanercept (TNFR:Fc) in this study.
  • Receipt of cyclosporin within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357903

Sponsors and Collaborators
Amgen
Immunex Corporation
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00357903     History of Changes
Other Study ID Numbers: 20021618, 16.0018
Study First Received: July 26, 2006
Results First Received: November 4, 2010
Last Updated: July 11, 2014
Health Authority: Canada: Health Canada
United States: Food and Drug Administration
United States: Western Institutional Review Board

Keywords provided by Amgen:
Rheumatoid Arthritis, Etanercept, Long-term Safety, Enbrel

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014