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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.
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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
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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