Evaluation of the Efficacy of Combination Treatment With Anakinra and Pegsunercept in Improving Rheumatoid Arthritis

This study has been completed.

Sponsor:

Information provided by:

Swedish Orphan Biovitrum

ClinicalTrials.gov Identifier:

NCT00037700

First received: May 20, 2002

Last updated: November 25, 2009

Last verified: December 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

May 20, 2002

Last Updated Date

November 25, 2009

Start Date ^ICMJE

May 2001

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00037700 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Evaluation of the Efficacy of Combination Treatment With Anakinra and Pegsunercept in Improving Rheumatoid Arthritis

Official Title ^ICMJE

Not Provided

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Rheumatoid Arthritis

Intervention ^ICMJE

Drug: anakinra
Drug: pegsunercept

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

December 2002

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00037700

Other Study ID Numbers ^ICMJE

20000198

Has Data Monitoring Committee

Not Provided

Responsible Party

Global Development Leader, Amgen Inc.

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Swedish Orphan Biovitrum

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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