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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
  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 2

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:

Drug Information available for: Anakinra
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: MD 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 June 13, 2013