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OpenTrials
Completed

NCT Number: NCT00111423

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Pegsunercept (PEG sTNF-RI)

Drug

Primary outcomes

  1. Treatment-emergent adverse events

Secondary outcomes

  1. Description of RA assessment outcomes

  2. Assessment of Compliance

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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)

Important dates

Study start
2002
First posted
May 23, 2005
Registry last updated
Mar 6, 2009

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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