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

This study has been completed.

First Received on May 20, 2002. Last Updated on November 25, 2009 History of Changes

Sponsor:	Amgen
Information provided by:	Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier:	NCT00037700

Purpose

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.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: anakinra Drug: pegsunercept	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Anakinra Pegsunercept

U.S. FDA Resources

Further study details as provided by Swedish Orphan Biovitrum:

Study Start Date:	May 2001
Estimated Study Completion Date:	December 2002

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00037700

Sponsors and Collaborators

Amgen

Investigators

Study Director:

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00037700 History of Changes
Other Study ID Numbers:	20000198
Study First Received:	May 20, 2002
Last Updated:	November 25, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases

Autoimmune Diseases
Immune System Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012