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

NCT ID: NCT02357459

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 486 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-01-31

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.

Detailed Description

This study was a double-blind, randomized, single dose design. The study was conducted in male and female patients ≥40 years of age with OA of the knee. Approximately 450 patients with OA of the knee were randomized to 1 of 3 treatment groups (1:1:1) and treated with a single IA injection of:

• 32 mg FX006,
• normal saline (placebo), or
• 40 mg TCA IR.

Randomization was stratified by weekly mean of the average daily (24-hour) pain intensity (ADP) scores at baseline, with the following classifications: 5 to <6, 6 to <7, and ≥7.

Each patient was evaluated for a total of 24 weeks following a single IA injection. Following screening, safety and efficacy were evaluated at 7 out-patient visits (Days 1 [baseline], Weeks 4, 8, 12, 16, 20, and 24). The study was expected to enroll in approximately 6 months.

Conditions

Osteoarthritis of the Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

FX006 32mg

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

Group Type: EXPERIMENTAL

FX006

Intervention Type: DRUG

Single 5 mL IA injection

Normal Saline

Single 5 mL intra-articular (IA) injection

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single 5 mL IA injection

TCA IR 40 mg

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

Group Type: ACTIVE_COMPARATOR

TCA IR 40

Intervention Type: DRUG

Single 1 mL IA injection

Interventions

FX006

Single 5 mL IA injection

Intervention Type: DRUG

Placebo

Single 5 mL IA injection

Intervention Type: DRUG

TCA IR 40

Single 1 mL IA injection

Intervention Type: DRUG

Other Intervention Names

Zilretta; Normal Saline; Kenalog®-40 Injection; Kenacort-A 40; Triamcinolone Acetonide Crystalline Suspension (TAcs)

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil Bodick, MD

Role: STUDY_DIRECTOR

Flexion Therapeutics

Locations

Phoenix, Arizona, United States

Tucson, Arizona, United States

Anaheim, California, United States

Canoga Park, California, United States

North Hollywood, California, United States

San Diego, California, United States

Denver, Colorado, United States

Atlantis, Florida, United States

DeLand, Florida, United States

Hialeah, Florida, United States

Sarasota, Florida, United States

West Palm Beach, Florida, United States

Prairie Village, Kansas, United States

Albuquerque, New Mexico, United States

Cary, North Carolina, United States

PMG Research of Cary

Cary, North Carolina, United States

Charlotte, North Carolina, United States

Duncansville, Pennsylvania, United States

PMG Research of Knoxville

Knoxville, Tennessee, United States

PMG Research of Knoxville

Knoxville, Tennessee, United States

Dallas, Texas, United States

Newport News, Virginia, United States

Broadmeadow, New South Wales, Australia

Geelong, New South Wales, Australia

Merewether, New South Wales, Australia

St Leonards, New South Wales, Australia

Sherwood, Queensland, Australia

Malvern, Victoria, Australia

Quebec, Ontario, Canada

Toronto, Ontario, Canada

Windsor, Ontario, Canada

Aalborg, , Denmark

Ballerup Municipality, , Denmark

Vejle, , Denmark

Tallinn, , Estonia

Hong Kong, , Hong Kong

Vilnius, , Lithuania

Bucharest, , Romania

Countries

United States; Australia; Canada; Denmark; Estonia; Hong Kong; Lithuania; Romania

References

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.

Reference Type: DERIVED

PMID: 34791634 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30968336 (View on PubMed)

Other Identifiers

FX006-2014-008

Identifier Type: -

Identifier Source: org_study_id