ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00037700
Recruitment Status : Completed
First Posted : May 21, 2002
Last Update Posted : November 26, 2009
Sponsor:
Information provided by:
Swedish Orphan Biovitrum

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: anakinra Drug: pegsunercept Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : May 2001
Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Anakinra

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00037700


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00037700     History of Changes
Other Study ID Numbers: 20000198
First Posted: May 21, 2002    Key Record Dates
Last Update Posted: November 26, 2009
Last Verified: December 2007

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