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Completed

NCT Number: NCT00357903

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

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.

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Key information

Conditions

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

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

etanercept

Biological

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).

Primary outcomes

  1. Total Exposure to Etanercept With Gaps

    Time frame: Up to 10 years

    Total participant exposure to etanercept (Enbrel) with gaps

  2. Total Exposure Adjusted Rate of Malignancies

    Time frame: Up to 10 years

    Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept

  3. Total Exposure Adjusted Rate of Deaths

    Time frame: Up to 10 years

    Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept

  4. Total Exposure Adjusted Rate of Serious Infectious Events

    Time frame: Up to 10 years

    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

  5. Total Exposure Adjusted Rate of Lymphomas

    Time frame: Up to 10 years

    Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept

  6. Malignancy

    Time frame: Up to 10 years

    Occurrence of one or more malignancies on study within 30 days of the last dose of etanercept

  7. Lymphoma

    Time frame: Up to 10 years

    Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept

  8. Serious Infectious Event

    Time frame: Up to 10 years

    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.

  9. Death

    Time frame: Up to 10 years

    Occurrence of death on study within 30 days of the last dose of etanercept

  10. Total Exposure Adjusted Rate of Serious Adverse Events

    Time frame: Up to 10 years

    Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100)

Secondary outcomes

  1. Dosing Period

    Time frame: Up to 10 years

    Duration of etanercept dosing

  2. Tender Joint Count

    Time frame: Month 12

    Number of tender joints, as assessed by the investigator using criteria based on pressure and joint manipulation

  3. Swollen Joint Count

    Time frame: Month 12

    Number of swollen joints

  4. Health Assessment Questionnaire Disability Index

    Time frame: Month 12

    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).

  5. Childhood Health Assessment Questionnaire

    Time frame: Month 12

    Childhood Health Assessment Questionnaire (CHAQ) disability index, having a range of 0 (no difficulty) to 3 (unable to do).

  6. C-Reactive Protein

    Time frame: Month 12

    C-reactive protein at month 12

  7. ACR20 at Month 3 in Adults

    Time frame: Baseline and month 3

    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

  8. JRA DOI 30 at Month 3 in Juveniles

    Time frame: Baseline and month 3

    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.

  9. Standardized Incidence Rate for All SEER Cancers

    Time frame: up to 10 years

    Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Collaborators

  • Immunex Corporation

Registry information

Official study 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

Important dates

Study start
1997
Primary completion
2008
Study completion
2009
First posted
Jul 28, 2006
Registry last updated
Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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