Who is sponsoring NCT01362608?

NCT01362608 is sponsored by Novartis Pharmaceuticals.

What condition does NCT01362608 study?

NCT01362608 studies Gouty Arthritis.

What drugs are being tested in NCT01362608?

Interventions: Canakinumab, ACZ885, Triamcinolone acetonide.

What is the status of NCT01362608?

NCT01362608 is currently TERMINATED.

Last reviewed 2017-06-08 · How we verify

Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective

NCT01362608 PHASE3 TERMINATED Results posted

The purpose of this pivotal Phase III study is to support the registration of canakinumab for the indication of gout in China, a replicate of global studies CACZ885H2356 \& CACZ885H2357 by demonstrating in patients with frequent flares of gout for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective, canakinumab 150 mg s.c. given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares compared to triamcinolone acetonide 40 mg i.m.

Details

Lead sponsor	Novartis Pharmaceuticals
Phase	PHASE3
Status	TERMINATED
Enrolment	136
Start date	Mon Jun 20 2011 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue May 19 2015 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Gouty Arthritis

Interventions

Canakinumab, ACZ885
Triamcinolone acetonide

Countries

China, Argentina, Singapore, Poland