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Evaluating the Safety of Extended Treatment with Pegsunercept (PEG sTNF-RI) in Subjects with Rheumatoid Arthritis (RA) - Article


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Clinical Trial: Evaluating the Safety of Extended Treatment with Pegsunercept (PEG sTNF-RI) in Subjects with Rheumatoid Arthritis (RA)

This study has been completed.

Sponsored by: Amgen
Information provided by: Amgen

Purpose

The purpose of this study is to evaluate the safety of an additional 28 weeks of treatment with pegsunercept for subjects who have completed treatment in a previous double-blind study (20000201 or 20000198). In addition, this study will evaluate the efficacy and the feasibility of subject self-administration on an outpatient basis.

Condition Treatment or Intervention Phase
Rheumatoid Arthritis
 Drug: Pegsunercept (PEG sTNF-RI)
Phase II

MedlinePlus related topics:  Rheumatoid Arthritis

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control

Official Title: Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of Extended Treatment with Pegsunercept (PEG sTNF-RI) in Subjects with Rheumatoid Arthritis (RA)

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Subjects who have completed 24 weeks of double-blind treatment in a previous protocol (20000201 or 20000198)
  • Females of childbearing potential and males must practice adequate contraception, in the judgement of the investigator, during the course of the study
  • The subject or legally acceptable representative must give informed consent for participation in the study before any study specific procedures are performed

Exclusion Criteria:

  • Greater than a 7-day duration from the week 24 visit in the previous study to the first dose in this study
  • Any medical disability or condition (e.g., evidence of clinically significant liver dysfunction, active infection requiring treatment with systemic anti-infective agents) that would interfere with the assessment of safety of the study material or would compromise the ability of the subject to provide adequate informed consent
  • Concurrent treatment with an investigational agent

More Information

AmgenTrials clinical trials website

CenterWatch Clinical Trials Listing Service

Study ID Numbers:  20020133
Record last reviewed:  May 2005
Last Updated:  May 20, 2005
Record first received:  May 20, 2005
ClinicalTrials.gov Identifier:  NCT00111423
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-24


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