Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
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|ClinicalTrials.gov Identifier: NCT01431638|
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : November 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Gouty Arthritis||Drug: Canakinumab 150mg in prefilled syringe||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||233 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 36-week Open-label Extension Study of CACZ885H2361 on the Safety and Tolerability of Canakinumab 150 mg s.c. Pre-filled Syringe (PFS) in Treating Acute Gouty Arthritis Flares in Frequently Flaring Patients|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
Experimental: Canakinumab 150mg
Canakinumab 150mg in prefilled syringe subcutaneously
Drug: Canakinumab 150mg in prefilled syringe
Canakinumab 150mg in prefilled syringe will be given in a single dose subcutaneously upon demand for gouty arthritis flares
- Safety and tolerability of repeated dosing of canakinumab 150mg s.c. PFS [ Time Frame: 36 weeks ]Frequency and severity of adverse event reports in patients who have received repeat dosing of canakinumab 150mg s.c. PFS
- Immunogenicity of repeated dosing of canakinumab 150mg s.c. PFS [ Time Frame: 36 weeks ]Presence or absence of Anti-ACZ885 antibody concentrations will be measured in patients who have received repeated dosing of canakinumab 150mg s.c. PFS
- The time to the first new gouty arthritis flare since the entry into the core study [ Time Frame: 36 weeks ]Time will be measured to the onset of the first gouty arthritis flare from the time of the initial dose of study drug in the CACZ885H2361 core study.
- Frequency of new gouty arthritis flares [ Time Frame: 36 Weeks ]The number of gouty arthritis flares will be recorded for the duration of the trial
- Signs and symptoms of new gouty arthritis flares [ Time Frame: 36 Weeks ]Likert and visual analogue (VAS) pain scales, patient and physician global assessment scales and the physician's assessment of tenderness, swelling and erythema of the most affected joint will be collected during every gouty arthritis flare and at the end of the study.
- Pharmacokinetics (PK) of canakinumab 150mg s.c. PFS [ Time Frame: 36 Weeks ]PK assessments at various time points will be carried out to characterize the PK properties of the PFS form of canakinumab, as well as provide supporting data in the interpretation of any immunogenicity findings.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431638
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|