NCT00111423

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P50-P75 for phase_2 rheumatoid-arthritis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 23, 2005

Completed
Last Updated

March 6, 2009

Status Verified

December 1, 2007

First QC Date

May 20, 2005

Last Update Submit

March 4, 2009

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, InflammationPegsunercept, PEG sTNF-RIAutoimmune, AmgenClinical Trials

Outcome Measures

Primary Outcomes (1)

  • Treatment-emergent adverse events

Secondary Outcomes (2)

  • Description of RA assessment outcomes

  • Assessment of Compliance

Interventions

Pegsunercept (PEG sTNF-RI)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Arthritis, RheumatoidInflammation

Interventions

PEGylated soluble tumor necrosis factor receptor I

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 20, 2005

First Posted

May 23, 2005

Study Start

August 1, 2002

Last Updated

March 6, 2009

Record last verified: 2007-12