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
  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:


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:
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 April 17, 2014