Trial intelligence / Profile preview

Pegloticase OLE in Symptomatic Gout

NCT01356498Phase 3

Key facts

Status: Completed
Start: Dec 2006
Primary completion: Jan 2010
Countries: 1
Sponsor: Savient Pharmaceuticals
Modality: Replacement Enzymes

Drugs: pegloticase
Conditions: gout

Overview

Phase 3, open-label trial of pegloticase in gout (3 arms), sponsored by Savient Pharmaceuticals. Primary endpoint: Serum Uric Acid at Week 101. Started Dec 2006; status: completed.

Design

3 arms

Study design: Non-randomizedOpen-label

q2 RCT
Patients previously in the q2 week arm of the RCT
q4 RCT
Patients previously in the q4 week arm of the RCT
Placebo in RCT
Patients previously in the placebo arm of the RCT

Who it enrols

Adult patients who completed treatment in one of two double-blind, placebo-controlled Phase 3 studies of PEG-uricase (C0405 or C0406). Patients with unstable angina, uncontrolled arrhythmia, uncontrolled hypertension, end-stage renal disease requiring dialysis, or anemia are excluded.

Endpoints

Primary

Serum Uric AcidWeek 101

Secondary

Tophus ResponseUp to 2 years
SF-36 Physical Component Summary ScoreWeek 101
Gout Flare FrequencyUp to 2 years
Gout Flare IncidenceUp to 2 years

Beyond the preview

Go deeper on NCT01356498.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT01356498.