Conditions: Osteoarthritis
Keywords: Osteo arthritis pain control intra- articular injections Knee OA
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 169
Healthy volunteers: no

Brief 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.

Detailed description:
This is a randomized, double-blind, parallel group, placebo controlled 18 weeks study, consisting of two parts:

1. Part A: an ascending single dose part in which the safety and tolerability of up to 4 different canakinumab doses are studied (starting dose 150 mg, maximum dose 600 mg).
2. Part B: a double-dummy, active-controlled, parallel design part in which the pain reduction of the canakinumab dose selected from part A is studied in comparison to Placebo and Naproxen.

Arms:
arm 1: In this ascending dose part, participants received a single intra-articular injection of canakinumab. The beginning dose was 150 mg, escalating to the 300 mg dose and then to 600 mg. arm 2: Participants received a single intra-articular injection of canakinumab-matching placebo. arm 3: Participants received a single intra-articular injection of canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks. arm 4: Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks. arm 5: Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.

Interventions: intervention 1: Canakinumab intervention 2: Placebo to canakinumab intervention 3: Naproxen intervention 4: Placebo to Naproxen
Intervention descriptions: intervention 1: Intra-articular injection intervention 2: Intra-articular injection intervention 3: Tablets for oral administration intervention 4: Tablets for oral administration

Protocol document: