Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
Part of paid clinical trials in Anniston, Alabama.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT01431638
- Phase
- PHASE3
- Status
- Completed
Conditions
- Acute Gouty Arthritis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- Canakinumab 150mg in prefilled syringe — DRUGCanakinumab 150mg in prefilled syringe will be given in a single dose subcutaneously upon demand for gouty arthritis flares
Study Details
This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.
Key Dates
- Start date
- Aug 25, 2011
- Status verified
- Jun 2021
- Primary completion
- May 9, 2013
- Completion
- May 9, 2013
Study Design
- Enrollment
- 397 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Canakinumab 150mgCanakinumab 150mg in prefilled syringe subcutaneously
Primary Outcome Measure
Number of Participants Who Reported Adverse Events [ Time Frame: From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks) ]
Locations (54)
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