Clinical Trials and Associated Publications

 

ONGOING CLINICAL TRIALS

Study to assess the safety of repeat administration of FX006 administered to patients with osteoarthritis of the knee. NCT03046446

Study to compare exposure of TA following administration of either FX006 or TAcs in patients with bilateral knee OA. NCT03378076

Study to compare exposure of TA following administration of FX006 or TAcs in patients with OA of the shoulder or hip. NCT03382262

PUBLICATIONS
Efficacy and Safety

Conaghan PG, et al. A phase IIb trial of a novel extended-release microsphere formulation of triamcinolone acetonide for intraarticular injection in knee osteoarthritis. Arthritis Rheumatol. 2017 Oct 31. doi: 10.1002/art.40364. [Epub ahead of print]. NCT02116972

Baraf HSB, et al. Effectiveness of FX006 intra-articular injection in patients with knee osteoarthritis who present with and without clinical inflammation at baseline: a pooled analysis of data from 3 double-blind, randomized, parallel-group clinical trials. Arthritis Rheumatol. 2017;69(suppl 10). Abstract 934. NCT01487161, NCT02116972, NCT02357459

Conaghan PG, et al. Updating the knee osteoarthritis intra-articular corticosteroid meta-analysis with two large trials of extended-release triamcinolone acetonide (FX006) versus placebo. Arthritis Rheumatol. 2017;69(suppl 10). Abstract 1200. NCT02116972, NCT02357459

Kivitz A, et al. Rescue medication usage by patients with osteoarthritis of the knee treated with triamcinolone acetonide extended-release (FX006): a post hoc, pooled analysis of three randomized controlled clinical trials. Postgrad Med. 2017;129(suppl 1):S1-85. Abstract 92. NCT01487161, NCT02116972, NCT02357459

Conaghan P, et al. An intra-articular, extended-release formulation of triamcinolone (FX006) affords clinically relevant improvements in pain and function of knee osteoarthritis: post hoc pooled analyses of three randomized controlled trials. Osteoarthritis Cartilage. 2017; 25 (Supplement 1):S432-S433. NCT01487161, NCT02116972, NCT02357459

Spitzer A, et al. Intra-articular injection of an extended-release formulation of triamcinolone acetonide provided significant improvement in pain, stiffness and function in patients with knee osteoarthritis. Presented as an oral at the AAHKS Annual Meeting, Friday, November 11, 2016. Paper #8. NCT02357459

Bodick N, et al. An intra-articular, extended-release formulation of triamcinolone acetonide prolongs and amplifies analgesic effect in patients with osteoarthritis of the knee: a randomized clinical trial. J Bone Joint Surg Am. 2015; 97(11):877-88. NCT01487161

Health Economics & Outcomes Research (HEOR)

Kelley S, et al. An intra-articular, extended-release formulation of triamcinolone acetonide as a cost-effective therapy for treating osteoarthritis of the knee. Value Health. 2017; 20(5):A145. NCT01487161, NCT02116972, NCT02357459

Pharmacokinetics

Kraus VB, et al. Synovial and systemic pharmacokinetics of triamcinolone acetonide following intra-articular injection of an extended-release microsphere-based formulation (FX006) or standard crystalline suspension in patients with knee osteoarthritis. Osteoarthritis Cartilage. 2018;26(1):34-42. NCT02637323

Russell S, et al. In type 2 diabetes mellitus patients with knee osteoarthritis, intra-articular injection of FX006 (extended-release triamcinolone) is associated with reduced blood glucose elevation vs. standard triamcinolone: a randomized, blinded, parallel-group study. Diabetes. 2017; 66(Supplement 1):A289. NCT02762370

Nonclinical

Williamson T, et al. Systemic and local effects following intra-articular injection of FX006, an extended-release, PLGA microsphere formulation of triamcinolone acetonide: results from two nonclinical toxicity studies in dogs. Osteoarthritis Cartilage. 2017; 25(Supplement 1):S431-S432.

Kumar A et al. Sustained efficacy of a single intra-articular dose of FX006 in a rat model of repeated localized knee arthritis. Osteoarthritis Cartilage. 2015; 23(1):151-60.