Study of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee

NCT02357459 | Completed Phase 3 Results

• 1 other identifier: FX006-2014-008
• Study Type: interventional
• Target: 486
• Locations: 8 countries
• Sites: 38

Brief Summary

The purpose of this study was to assess the safety and efficacy of FX006 for the treatment of pain in patients with osteoarthritis of the knee.

Conditions

Osteoarthritis of the Knee

Keywords

osteoarthritis; knee; pain; corticosteroid; intra-articular; injection

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain (ADP) Intensity Scores for 32 mg FX006 Versus Placebo

  The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."

  Baseline and 12 Weeks

Secondary Outcomes (4)

• Area Under the Effect Curve (AUE) of Change From Baseline in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to Placebo

  Baseline to 12 Weeks

• AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR

  Baseline to 12 Weeks

• Change From Baseline to Week 12 in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR

  Baseline through 12 Weeks

• AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for FX006 Relative to Placebo

  Baseline to 24 Weeks

Other Outcomes (9)

• Change From Baseline to Each Week in Weekly Mean of the ADP Scores

  Weeks 1-11 & Weeks 13-24

• Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24.

  Weeks 4, 8, 12, 16, 20, and 24

• Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24

  Weeks 4, 8, 12, 16, 20 and 24

Study Arms (3)

FX006 32mg

EXPERIMENTAL

Single 5 mL intra-articular (IA) injection Extended-release Formulation

Drug: FX006

Normal Saline

PLACEBO COMPARATOR

Single 5 mL intra-articular (IA) injection

Drug: Placebo

TCA IR 40 mg

ACTIVE COMPARATOR

Single 1 mL intra-articular (IA) injection TCA IR 40 mg: Immediate-release formulation

Drug: TCA IR 40

Interventions

FX006 DRUG

Single 5 mL IA injection

Also known as: Zilretta

FX006 32mg

Placebo DRUG

Single 5 mL IA injection

Also known as: Normal Saline

Normal Saline

TCA IR 40 DRUG

Single 1 mL IA injection

Also known as: Kenalog®-40 Injection, Kenacort-A 40, Triamcinolone Acetonide Crystalline Suspension (TAcs)

TCA IR 40 mg

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
• Male or female \>=40 years of age
• Has symptoms associated with OA of the index knee for at least 6 months prior to Screening
• Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA
• Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee per Screening X-ray
• Index knee pain for \> 15 days over the last month
• Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)
• Body mass index (BMI) ≤ 40 kg/m2
• Willingness to abstain from use of restricted medications

You may not qualify if:

• Any condition that could possibly confound the patient's assessment of index knee pain in judgement of the investigator (i.e., iIpsilateral hip OA, gout, radicular low back pain and hip pain that is referred to the knee that could cause misclassification, pain in any other area of the lower extremities or back that is equal or greater than the index knee pain)
• Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease
• History of infection in the index knee
• Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening
• Unstable joint within 12 months of screening
• IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
• IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
• Intramuscular (IM) or oral corticosteroids (investigational or marketed) within 1 month of Screening
• Any other IA investigational drug/biologic within 6 months of Screening
• Prior use of FX006
• Women of child-bearing potential not using effective contraception or who are pregnant or nursing

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (38)

Unknown Facility

Phoenix, Arizona, 85023, United States

Location

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Tucson, Arizona, 85712, United States

Location

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Anaheim, California, 92801, United States

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Canoga Park, California, 91303, United States

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North Hollywood, California, 91606, United States

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San Diego, California, 92103, United States

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Denver, Colorado, 80209, United States

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Atlantis, Florida, 33462, United States

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DeLand, Florida, 32720, United States

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Hialeah, Florida, 33012, United States

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Sarasota, Florida, 34232, United States

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West Palm Beach, Florida, 33409, United States

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Prairie Village, Kansas, 66206, United States

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Albuquerque, New Mexico, 87102, United States

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Cary, North Carolina, 27518, United States

Location

PMG Research of Cary

Cary, North Carolina, United States

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Charlotte, North Carolina, 28209, United States

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Duncansville, Pennsylvania, 16635, United States

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PMG Research of Knoxville

Knoxville, Tennessee, 37912, United States

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PMG Research of Knoxville

Knoxville, Tennessee, 37938, United States

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Dallas, Texas, 75231, United States

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Newport News, Virginia, 23606, United States

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Broadmeadow, New South Wales, 02292, Australia

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Geelong, New South Wales, 03220, Australia

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Merewether, New South Wales, 02291, Australia

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St Leonards, New South Wales, 02065, Australia

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Sherwood, Queensland, 04075, Australia

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Malvern, Victoria, 03145, Australia

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Quebec, Ontario, G1W4R4, Canada

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Toronto, Ontario, M9V4B4, Canada

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Windsor, Ontario, N8W1E6, Canada

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Aalborg, Denmark

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Ballerup Municipality, Denmark

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Vejle, Denmark

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Tallinn, Estonia

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Hong Kong, Hong Kong

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Vilnius, 10323, Lithuania

Location

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Bucharest, 30463, Romania

Location

Related Publications (2)

• Ross E, Katz NP, Conaghan PG, Kivitz A, Turk DC, Spitzer AI, Jones DG, Lanier RK, Cinar A, Lufkin J, Kelley SD. Improved Treatment Effect of Triamcinolone Acetonide Extended-Release in Patients with Concordant Baseline Pain Scores on the Average Daily Pain and Western Ontario and McMaster Universities Osteoarthritis Index Pain Scales. Pain Ther. 2022 Mar;11(1):289-302. doi: 10.1007/s40122-021-00335-z. Epub 2021 Nov 17.

  PMID: 34791634 DERIVED

• Langworthy MJ, Conaghan PG, Ruane JJ, Kivitz AJ, Lufkin J, Cinar A, Kelley SD. Efficacy of Triamcinolone Acetonide Extended-Release in Participants with Unilateral Knee Osteoarthritis: A Post Hoc Analysis. Adv Ther. 2019 Jun;36(6):1398-1411. doi: 10.1007/s12325-019-00944-3. Epub 2019 Apr 9.

  PMID: 30968336 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain

Interventions

FX006; Triamcinolone; Saline Solution; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Subsequent to completion of clinical studies extensive testing was performed to assess the actual FX006 dose delivered. It was determined that the FX006 delivered dose to the patient from an FX006 40 mg vial is 32 mg.

Results Point of Contact

• Title: Scott Kelley, VP of Medical Affairs
• Organization: Flexion Therapeutics

skelley@flexiontherapeutics.com

781-305-7142

Study Officials

• Neil Bodick, MD

  Flexion Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: February 6, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 24, 2024
• Results First Posted: February 1, 2018

Record last verified: 2024-01

Locations

LI (1); CA (3); ES (1); US (22); DK (3); HK (1); RO (1); AU (6)