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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.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00111423
First received: May 20, 2005
Last updated: March 4, 2009
Last verified: December 2007
History of Changes
  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 Intervention Phase
Rheumatoid Arthritis
 Drug: Pegsunercept (PEG sTNF-RI)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00111423

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

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site
Notice regarding posted summaries of trial results  This link exits the ClinicalTrials.gov site
To access clinical trial results information click on this link  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00111423     History of Changes
Other Study ID Numbers: 20020133
Study First Received: May 20, 2005
Last Updated: March 4, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013