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

May 20, 2002
November 25, 2009
May 2001
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Complete list of historical versions of study NCT00037700 on ClinicalTrials.gov Archive Site
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Evaluation of the Efficacy of Combination Treatment With Anakinra and Pegsunercept in Improving Rheumatoid Arthritis
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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.

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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: anakinra
  • Drug: pegsunercept
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2002
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  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00037700
20000198
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Global Development Leader, Amgen Inc.
Amgen
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Study Director: MD Amgen
Swedish Orphan Biovitrum
December 2007

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