Who is sponsoring NCT00537667?

NCT00537667 is sponsored by Amgen.

What condition does NCT00537667 study?

NCT00537667 studies Rheumatoid Arthritis.

What drugs are being tested in NCT00537667?

Interventions: anakinra, anakinra and PEG sTNF-R1.

What is the status of NCT00537667?

NCT00537667 is currently TERMINATED.

Last reviewed 2009-11-25 · How we verify

A Single Centre, Open-Label, Randomised, Study to Evaluate the Effect of Anakinra (r-metHuIL-1ra) Alone and in Combination With PEGylated Recombinant Methionyl Human Soluble Tumour Necrosis Factor Receptor Type I (PEG sTNF-RI) on Synovial Inflammation in Subjects With Rheumatoid Arthritis.

NCT00537667 Phase 2 TERMINATED

The purpose of this study is to compare IL-1ra and the combination of IL-1ra and PEGsTNF-RI with respect to their ability to reduce inflammation and bone and cartilage destruction in the synovium of subjects with rheumatoid arthritis.

Details

Lead sponsor	Amgen
Phase	Phase 2
Status	TERMINATED
Enrolment	22
Start date	2001-08
Completion	2003-06

Conditions

Rheumatoid Arthritis

Interventions

anakinra
anakinra and PEG sTNF-R1

Primary outcomes

Primary efficacy endpoint is the change from baseline at weeks 4, 26 and 52 in levels of select markers of inflammation (CD3 and CD 68) and destruction (MMP-1 and TIMP-1) in the synovium — up to 52 weeks
Primary safety endpoint is the crude and exposure adjusted subject incidence and nature, frequency, severity, relationship to treatment, and outcome of all adverse events — up to 52 weeks