NCT00037700

Brief Summary

The purpose of this study is to evaluate the effect of anakinra (IL-1 ra) and pegsunercept (PEG sTNF-RI) when they are used together in improving the signs and symptoms of rheumatoid arthritis. The study will also evaluate the safety of the combination treatment and its effect on slowing down bone and joint destruction due to rheumatoid arthritis. The results will be compared to the effect when only 1 single medication (anakinra or pegsunercept) is used.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started May 2001

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

May 1, 2001

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2002

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
Last Updated

November 26, 2009

Status Verified

December 1, 2007

First QC Date

May 20, 2002

Last Update Submit

November 25, 2009

Conditions

Rheumatoid Arthritis

Interventions

anakinraDRUG
pegsunerceptDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* diagnosed with rheumatoid arthritis for at least 6 months * must be taking methotrexate \* must not take DMARDS other than methotrexate during the study * must not have had previous treatment with and protein-based TNF-alpha inhibitor (eg. etanercept, infliximab, PEG sTNF-RI, or D2E7) * must not have had previous treatment with anakinra * subjects must meet tender and swollen joint requirements at screening, have morning stiffness, and/or have elevated acute phase reactants

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Interleukin 1 Receptor Antagonist ProteinPEGylated soluble tumor necrosis factor receptor I

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

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, 2002

First Posted

May 21, 2002

Study Start

May 1, 2001

Study Completion

December 1, 2002

Last Updated

November 26, 2009

Record last verified: 2007-12