Clinical Trials and Associated Publications

Study to Evaluate the Safety and Tolerability of FX201 in Patients With Osteoarthritis of the Knee. NCT04119687

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

Review Articles

Paik J, et al. Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee Drugs. 2019; 79: 455. https://doi.org/10.1007/s40265-019-01083-3

Clinical Trials – Efficacy and Safety

Phase 2/2b/3 Pooled – Single Administration
Kivitz AJ, et al. Rescue analgesic medication use by patients treated with triamcinolone acetonide extended-release for knee osteoarthritis pain: pooled analysis of three phase 2/3 randomized clinical trials. Pain Ther. 2019; https://doi.org/10.1007/s40122-019-0125-1. NCT02357459, NCT02116972, NCT01487161

Phase 3 – Post-Hoc
Langworthy MJ, et al. Efficacy of Triamcinolone Acetonide Extended-Release in Participants with Unilateral Knee Osteoarthritis: A Post Hoc Analysis. Adv Ther. 2019; https://doi.org/10.1007/s12325-019-00944-3. NCT02357459

Phase 3b – Repeat Administration
Spitzer, AI, 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 – Single Administration
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 – Single Administration
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 – Single Administration
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

Clinical Trials – Pharmacokinetics/Pharmacodynamics

Phase 2 – Single Administration
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 – Single Administration, 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

Compatibility with Local Anesthetics – In Vitro Model
Jackson JD, et al. Physical and chemical compatibility of extended-release triamcinolone acetonide (TA-ER) with common local anesthetics. Adv Ther. 2019 Jan 31. doi: 10.1007/s12325-019-0878-2 [Epub ahead of print]

Single and Repeat Administration – Canine Model
Bodick N, et al. Local effects following single and repeat intra-articular injections of triamcinolone acetonideextended-release: results from three nonclinical toxicity studies in dogs. Rheumatol Ther. 2018; 5: 475. https://doi.org/10.1007/s40744-018-0125-3

Single Administration – 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

2019

Senter R, Boyce R, Chabicovsky, Walsh Martin E, Langevin-Carpentier G, Bodick N. The Rat Homolog to FX201, a Gene Therapy in Development for the Treatment of Osteoarthritis, Demonstrates Dose-Dependent Decreases in the Severity of Cartilage and Bone Lesions Following Anterior Cruciate Ligament Transection. Presented at the 2019 American College of Rheumatology Annual Meeting; November 8-13, 2019; Atlanta, GA

Conaghan P, Ross E, Kivitz A, Turk D, Spitzer A, Jones D, Lanier R, Cinar A, Lufkin J, Kelley S. Concordance of Baseline Pain Measures (Across Two Reporting Instruments) Influences Treatment Effect: Post Hoc Analysis of a Phase 3 Randomized Controlled Trial of Triamcinolone Acetonide Extended-Release in Patients with Knee Osteoarthritis. Presented at the 2019 American College of Rheumatology Annual Meeting; November 8-13, 2019; Atlanta, GA

Bowes M, Kacena K, Alabas O, Brett A, Dube B, Bodick N, Conaghan P. Machine Learning Defines the Relationship Between Structural Knee Osteoarthritis and Patient-Important Outcomes: An 8-year Study of 47,858 Knee MRIs from the Osteoarthritis Initiative (OAI). Presented at the 2019 American College of Rheumatology Annual Meeting; November 8-13, 2019; Atlanta, GA

Jones D,  Ross E, Conaghan P, Kivitz A, Turk D, Spitzer A, , Lanier R, Cinar A, Lufkin J, Kelley S. Extended-Release Triamcinolone Acetonide Enhanced Magnitude and Duration of Pain Relief Compared with Conventional Triamcinolone in Patients with Confirmed Moderate-to-Severe Knee Osteoarthritis. Presented at the 2019 American Association of Hip and Knee Surgeons Annual Meeting; November 7-10, 2019; Dallas, TX

Jones D, Gomoll A, Richmond J, Spitzer A, Kraus V, Hufman K, Cinar A, Lufkin J, Kelley S. Expanding the Potential of Nonoperative Therapies In Advanced Knee Osteoarthritis: Treatment Response to Repeat Administration Triamcinolone Acetonide Extended-Release Is Similar Across Kellgren-Lawrence Grades 2-4. Presented at the 2019 American Orthopaedic Society Sports Medicine Annual Meeting; July 11-14, 2019; Boston, MA

Huffman K, Richmond J, Spitzer A, Gomoll A, Jones D, Kraus V, Cinar A, Lufkin J, Kelley S. Initial/Repeat Triamcinolone Acetonide Extended-Release (TA-ER) Reduces Osteoarthritis Knee Pain Regardless of Prior Intra-Articular Corticosteroids (IACS). Presented at the 2019 American College of Sports Medicine Annual Meeting; May 28-June 1, 2019; Orlando, FL

Richmond J, Spitzer A, Kraus V, Gomoll A, Jones D, Huffman K, Cinar A, Lufkin J, Kelley S. Repeat Triamcinolone Acetonide Extended-Release (TA-ER) in Patients With Bilateral or Unilateral Osteoarthritis (OA). Presented at the 2019 American Medical Society for Sports Medicine; April 12-17, 2019; Houston, TX

Ross E, Cinar A, Lufkin J, Kelley S. Concordance of Baseline Pain Measures Influences Treatment Effect: Post-Hoc Analysis of 3 Randomized Controlled Trials of Triamcinolone Acetonide Extended-Release in Patients with Knee Osteoarthritis. J Pain. April 2019, Volume 20, Issue 4, Supplement, Page S73, Abstract 404

Frank E, Hung H, Krishnan Y, Senter B, Bodick N, Grodzinsky A. Dose-Dependent Chondroprotective Effects of Triamcinolone Acetonide on Inflamed and Injured Cartilage Using an In Vitro Model. Presented as a poster presentation at the 2019 Orthopaedic Research Society; February 2-5, 2019; Austin, TX

2018

Conaghan PG, Russell SJ, Sala R, Habib G, Vo Q, Manning R, Kivitz A, Davis Y, Lufkin J, Johnson JR, Kelley S. Triamcinolone acetonide extended-release injectable suspension (TA-ER) is associated with reduced blood glucose elevation vs. standard triamcinolone in type 2 diabetes mellitus patients with knee osteoarthritis: a randomized, blinded, parallel-group study. Osteoarthritis Cartilage. 2018;26(suppl 1):S230

Katz NP, Conaghan PG, Kraus VB, Lufkin J, Johnson JR, Kelley S. Triamcinolone acetonide extended-release injectable suspension (TA-ER) provides clinically relevant improvements in pain and function of knee osteoarthritis: a pooled analysis of 3 randomized clinical trials employing composite assessments. Osteoarthritis Cartilage. 2018;26(suppl 1):S232-S233

Kelley SD, Hayashi DE, Gricar B, Riley DD, Peyerl FW. Cost effectiveness analysis of intra-articular triamcinolone acetonide extended-release injectable suspension (TA-ER) versus triamcinolone acetonide crystalline suspension for symptomatic knee osteoarthritis. Value Health. 2018;21(suppl 1):S197-S198

Kivitz A. Kwong L, Shlotzhauer T, Lufkin J, Curto T, Kelley S. Systemic exposure of triamcinolone acetonide following bilateral injection of extended-release triamcinolone acetonide and standard triamcinolone in patients with bilateral knee osteoarthritis. Arthritis Rheumatol.2018;70(suppl 9). Abstract 1371

Langworthy MJ, Lufkin JL, Johnson JR, Kelley S. Efficacy of triamcinolone acetonide extended-release in patients with unilateral knee osteoarthritis. Presented at the 2018 Military Health System Research Symposium; August 20-23, 2018; Kissimmee, FL

Rosen J, Conaghan P, Johnson J, Kelley S. Effects of an intra-articular, extended-release corticosteroid (FX006) treatment on health-related quality of life in patients with knee osteoarthritis: comparison with general population controls. Presented at the 2018 Annual Meeting of the American Academy of Orthopedic Surgeons; March 6-10, 2018; New Orleans, LA. Abstract P0906

Ruane JJ, Kivitz A, Lufkin J, Johnson J, Kelley S. Efficacy of triamcinolone acetonide extended-release injectable suspension in patients with unilateral knee osteoarthritis. J Manag Care Pharm. 2018;24(4-a):S88-S89

Spitzer A, Richmond J, Jones D, Conaghan P, Lufkin J, Jiang J, Kelley S. Impact of prior intra-articular corticosteroid injections on the efficacy of FX006, an intra-articular extended-release formulation of triamcinolone acetonide, in patients with osteoarthritis of the knee: post-hoc, pooled analysis of three randomized controlled trials. Presented at the 2018 Annual Meeting of the American Academy of Orthopedic Surgeons; March 6-10, 2018; New Orleans, LA. Abstract 908

Spitzer AI, Richmond J, Gomoll A, Jones DG, Kraus VB, Lufkin J, Johnson JR, Kelley S. Assessment of the safety of repeat administration of triamcinolone acetonide extended-release injectable suspension in patients with knee osteoarthritis: trial design, methods and preliminary data. Osteoarthritis Cartilage. 2018;26(suppl 1):S251-S252

2017

Baraf HSB, Lattermann C, Jones DG, Conaghan PG, Lufkin J, Johnson J, Kelley S, Bodick N. 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

Conaghan PG, Berenbaum F, Kraus VB, Johnson J, Kelley S. 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

Conaghan PG, Strand V, Hunter D, Kraus VB, Berenbaum F, Katz NP, Lufkin J, Johnson JR, Kelley S, Bodick N. 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 3 randomized controlled trials. Osteoarthritis Cartilage. 2017;25(suppl 1):S432-S433

Kelley SD, Johnson JR, Thornton D, Skaar JR, Varsos GV, Peyeri FW. 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. Poster PMS28

Kivitz A, Aazami H, Conaghan PG, Johnson JR, Lufkin J, Kelley S. 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

Kraus VB, Aazami HA, Mehra P, Kivitz AJ, Lufkin J, Hauben J, Johnson JR, Bodick N. Synovial and systemic pharmacokinetics of triamcinolone acetonide following intra-articular injection of an extended release formulation (FX006) or standard crystalline suspension in patients with knee osteoarthritis. Osteoarthritis Cartilage. 2017;25(suppl 1):S431

Russell SJ, Sala R, Conaghan PG, Habib G, Vo Q, Manning R, Kivitz A, Davis Y, Lufkin J, Johnson JR, Kelley S, Bodick N. 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(suppl 1):A289. Abstract 1091-P

Williamson TL, Walz A, Garlick D, Lightfoot-Dunn R, Schafer K, Kelley S, Bodick N. 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(suppl 1):S431-S432

2016

Conaghan PG, Cohen S, Jordan J, Berenbaum F, Lufkin J, Wilwerth C, Clayman M, Doyle MK, Bodick N. Sustained and profound analgesic benefits in people with osteoarthritis of the knee using FX006, an intra-articular extended-release formulation of triamcinolone acetonide: results from a double-blind, randomized, parallel-group, dose-ranging study. Osteoarthritis Cartilage. 2016;24(suppl 1):S49-S50. Abstract 70

Spitzer AI, Lieberman J, Jones D, Jevsevar D, Lufkin J, Johnson JR, Doyle MK, Bodick N. Intra-articular injection of an extended-release formulation of triamcinolone acetonide provided significant improvements in pain, stiffness and function in patients with knee osteoarthritis. Presented at the 26^th Annual Meeting of the American Association of Hip and Knee Surgeons; November 10-13, 2016; Dallas, TX. Paper #8

2015

Bodick N, Lufkin J, Willwerth C, Hauben J, Kumar A, Boen P, Bolognese J, Schoonmaker C, Clayman M. Prolonged joint residency of triamcinolone acetonide after an intra-articular injection of FX006, a sustained release formulation for the treatment of osteoarthritis. Osteoarthritis Cartilage. 2015;23(suppl 2):A360-361. Abstract 591

2014

Bodick N, Lufkin J, Willwerth C, Kumar A, Bolognese J, Schoonmaker C, Hunter D, Clayman MD. Safety and efficacy of FX006 in patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2014;22(suppl):S376-S377. Abstract 668

Kumar A, Walz A, Garlick D, Spainhour C, Bodick N. A single intra-articular dose of FX006, an extended-release formulation of triamcinolone acetonide, has a similar effect on cartilage in healthy dogs as the commonly used kenalog-40® suspension. Osteoarthritis Cartilage. 2014;22(suppl):S463-S464. Abstract 848

2013

Bodick N, Lufkin J, Willwerth C, Lachance P, Jasey G, Gupta A, Chris A, Russo M, O’Mahony M, Henein S, Murdoch L, de Looze F, Hunter D, Clayman M. A randomized, double-blind, dose ranging study comparing FX006, an intra-articular (IA) sustained-release formulation of triamcinolone acetonide (TCA), to an approved injectable suspension of TCA in patients with osteoarthritis (OA) of the knee. Arthritis Rheumatism. 2013;65(s10):S1138. Abstract 2668

Bodick N, Lufkin J, Willwerth C, Blanks R, Inderjeeth C, Kumar A, Clayman M. FX006 prolongs the residency of triamcinolone acetonide in the synovial tissues of patients with knee osteoarthritis. Osteoarthritis Cartilage. 2013;21(suppl):S144-S145. Abstract 267

2012

Kumar A, Bendele AM, Blanks RC, Bodick N. Sustained efficacy of intra-articular FX006 in a rat model of osteoarthritis. Osteoarthritis Cartilage. 2012;20(suppl 1):S289. Abstract 576