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

This study has been completed.
Information provided by:
Amgen Identifier:
First received: May 20, 2005
Last updated: March 4, 2009
Last verified: December 2007
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 Intervention Phase
Rheumatoid Arthritis Drug: Pegsunercept (PEG sTNF-RI) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Treatment-emergent adverse events

Secondary Outcome Measures:
  • Description of RA assessment outcomes
  • Assessment of Compliance

Estimated Enrollment: 216
Study Start Date: August 2002

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Please refer to this study by its identifier: NCT00111423

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00111423     History of Changes
Other Study ID Numbers: 20020133
Study First Received: May 20, 2005
Last Updated: March 4, 2009

Keywords provided by Amgen:
Rheumatoid Arthritis, Inflammation
Pegsunercept, PEG sTNF-RI
Autoimmune, Amgen
Clinical Trials

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on September 21, 2017