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

Amgen

Status and phase

Completed

Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Drug: pegsunercept

Drug: anakinra

Study type

Interventional

Funder types

Industry

Identifiers

NCT00037700

20000198

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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