Phase 2
N=200
Targeted Dose Finding of Canakinumab (ACZ885) for Management of Acute Flare in Refractory or Contraindicated Gout Patients
Acute Gout
Bottom Line
View on ClinicalTrials.gov: NCT00798369 ↗Enrolled (actual)
200
Serious AEs
2.5%
Results posted
May 2011
Primary outcome: Primary: The Dose of Canakinumab for Treatment of Acute Flares in Gout Patients That Leads to the Same Efficacy as Triamcinolone Acetonide With Respect to Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) — 37; 23; NA mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Canakinumab (Drug); Triamcinolone acetonide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Dose of Canakinumab for Treatment of Acute Flares in Gout Patients That Leads to the Same Efficacy as Triamcinolone Acetonide With Respect to Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) |
37; 23; NA | — |
| SECONDARY The Change in Pain Intensity in the Target Joint Following Canakinumab Administration Compared to Triamcinolone Acetonide |
-48.6; -46.6; -48.6; -52.7; -62.5; -43.3 | — |
| SECONDARY Percentage of Participants With an Excellent or Good Response With Regards to the Patient's Global Assessment of Response to Treatment |
64; 62; 71; 66; 89; 54 | — |
| SECONDARY The Time to 50% Reduction of Baseline Pain Intensity in the Target Joint |
2.9; 2.9; 1.0; 1.0; 1.0; 2.0 | — |
| SECONDARY High Sensitivity C-reactive Protein (hsCRP) at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group |
16.7; 7.9; 11.7; 13.4; 9.2; 13.4 | — |
| SECONDARY Serum Amyloid Protein (SAA) Levels at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group |
50.1; 27.6; 70.7; 29.4; 26.9; 52.5 | — |
| SECONDARY Amount of Rescue Medication Taken for Each Treatment Group |
1414.3; 1656.9; 2178.6; 1646.6; 607.4; 1614.3 | — |
Summary
This 8-week study is designed to determine the target dose of canakinumab (ACZ885) for the management of acute flare in gout patients who are contraindicated to Non-Steroidal anti-inflammatory drugs and/or colchicine. The efficacy of ACZ885 will be compared to the corticosteroid triamcinolone acetonide.
Eligibility Criteria
Inclusion Criteria
- History of at least 1 gout flare prior to the Screening Visit
- Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of acute arthritis of primary gout.
- Presence of acute gout flare for no longer than 5 days.
- Baseline pain intensity > or = to 50 mm on the 0-100 mm VAS.
- Contraindicated for, intolerant or unresponsive to NSAIDs, colchicine or both.
Exclusion Criteria
- Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
- Presence of severe renal function impairment
- Contraindication to intramuscular injection
- Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment
- Evidence of active pulmonary disease
- Live vaccinations within 3 months prior to the start of the study
- Use of forbidden therapy
Other protocol-defined inclusion/exclusion criteria applied
Data sourced from ClinicalTrials.gov (NCT00798369). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.