At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 169 enrolled
Drug / intervention
Canakinumab +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double Blind, Placebo and Naproxen Controlled, Multi-center, Study to Determine the Safety, Tolerability, Pharmacokinetics and Effect on Pain of a Single Intra-articular Administration of Canakinumab in Patients With Osteoarthritis in the Knee
In Brief
A Phase 2 clinical trial evaluating Canakinumab, Placebo to canakinumab, and 2 other interventions for Osteoarthritis. Completed, enrolled 169 participants across 13 sites in 4 countries.
Detailed Summary
The purpose of this study was to determine whether, in patients with mild to moderate knee osteoarthritis, canakinumab is safe and tolerable when injected intra-articularly.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis
CountriesFinland, France, Germany, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2010
First PostedJul 2010
Primary CompletionJul 2011
TodayJul 2026
First PostedJul 12, 2010
Enrollment StartApr 1, 2010
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.0 years ago
Interventions
Canakinumabbiological
Intra-articular injection
Placebo to canakinumabdrug
Intra-articular injection
Naproxendrug
Tablets for oral administration
Placebo to Naproxendrug
Tablets for oral administration