Clinical Trials and Associated Publications

Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis. NCT03793010

Study to evaluate the effect of FX006 on synovial inflammation in patients with OA of the knee. NCT03529942

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

Phase 3b Clinical Trial – Safety & Efficacy of Repeat Administration
Spitzer, A.I., et al. Safety and Efficacy of Repeat Administration of Triamcinolone Acetonide Extended-release in Osteoarthritis of the Knee: A Phase 3b, Open-label Study. Rheumatol Ther. 2019. doi.org/10.1007/s40744-019-0140-z. NCT03046446

Phase 3 Clinical Trial – Efficacy & Safety
Conaghan PG, et al. Effects of a single intra-articular injection of a microsphere formulation of triamcinolone acetonide on knee osteoarthritis pain; a double-blinded, randomized, placebo-controlled, multinational study. J Bone Joint Surg Am. 2018 Apr 18;100(8):666-677. NCT02357459

Phase 2b Clinical Trial – Efficacy & 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. 2018 Feb;70(2):204-211. NCT02116972

Phase 2 Clinical Trial – Efficacy & Safety
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

Phase 2 Clinical Trial – 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

Phase 2 Clinical Trial – Pharmacokinetics in Patients with Type 2 Diabetes
Russell SJ, et al. Triamcinolone acetonide extended-release in patients with osteoarthritis and type 2 diabetes: a randomized, phase 2 study, Rheumatology, key265, 2018 Sep 06. NCT02762370

Nonclinical Study – Rat Model
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.

Phase 2 Clinical Study – Effect on Blood Glucose in Type 2 Diabetes Patients
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 Toxicity
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.

Post-hoc Pooled Analysis – Rescue Medication Usage
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

Post-hoc Pooled Analysis – Various Assessments of Clinical Relevance
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

Post-hoc Pooled Sub-group Analysis – Efficacy & Safety by Baseline Inflammation
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

Post-hoc Pooled Sub-group Analysis – Efficacy & Safety by Prior Steroid Injection
Spitzer A, et al. Impact of prior intra-articular corticosteroid injections on the efficacy of FX006, an intra-articular extended-release formulation of triamcinolone acetonide, in patients with knee osteoarthritis. Presented as an oral at the 2018 Annual Meeting of the American Academy of Orthopedic Surgeons (AAOS); Friday, March 9, 2018; Abstract 908. NCT01487161, NCT02116972, NCT02357459

Meta-analysis – Addition of Phase 2b and Phase 3 Trials to Intra-articular Corticosteroid Meta-analysis
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

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