Pediatric Open-Label Extension Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00141921
First received: August 31, 2005
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to evaluate the long-term safety and efficacy of etanercept in pediatric subjects with moderate to severe psoriasis.


Condition Intervention Phase
Pediatric Plaque Psoriasis
Drug: Etanercept
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study to Evaluate the Safety of Etanercept in Pediatric Subjects With Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Subject incidence of adverse events, including infectious episodes, serious adverse events, and serious infectious episodes [ Time Frame: 168 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Injection site reactions [ Time Frame: 168 Weeks ] [ Designated as safety issue: Yes ]
  • exposure adjusted event rates for adverse events [ Time Frame: 168 Weeks ] [ Designated as safety issue: Yes ]
  • infections and injection site reactions [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
  • physical examination [ Time Frame: 168 weeks ] [ Designated as safety issue: No ]
  • vital signs [ Time Frame: 168 weeks ] [ Designated as safety issue: No ]
  • laboratory toxicities [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
  • anti-etanercept antibodies [ Time Frame: 168 weeks ] [ Designated as safety issue: Yes ]
  • PASI 50 [ Time Frame: 168 weeks ] [ Designated as safety issue: No ]
  • PASI 75 [ Time Frame: 168 weeks ] [ Designated as safety issue: No ]
  • PASI 90 [ Time Frame: 168 weeks ] [ Designated as safety issue: No ]
  • Clear or almost clear status of sPGA [ Time Frame: 168 weeks ] [ Designated as safety issue: No ]
  • percent improvement in CDLQI [ Time Frame: 168 Weeks ] [ Designated as safety issue: No ]
  • improvement from baseline in joint pain [ Time Frame: 168 weeks ] [ Designated as safety issue: No ]
  • Percent improvement in PASI score [ Time Frame: 168 weeks ] [ Designated as safety issue: No ]

Enrollment: 182
Study Start Date: August 2005
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etanercept Drug: Etanercept
open-label at a dose of 0.8 mg/kg (up to an intended dose of 50 mg) given QW SC in 1 or 2 injections

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: - Enrollment on previous Amgen study 20030211 Exclusion Criteria: - Serious or clinically significant adverse event on Amgen study 20030211 related to etanercept

  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: NCT00141921

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

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00141921     History of Changes
Other Study ID Numbers: 20050111
Study First Received: August 31, 2005
Last Updated: July 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Immunex
Amgen
Pediatric,
plaque psoriasis
clinical trial

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014