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Study to Compare Exposure of TA Following Administration of FX006 or TAcs in Patients With OA of the Shoulder or Hip

Primary Purpose

Osteoarthritis of the Shoulder, Osteoarthritis of the Hip

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

FX006 32 mg

TAcs 40 mg

About this trial

This is an interventional treatment trial for Osteoarthritis of the Shoulder focused on measuring Osteoarthritis, Shoulder, Hip, Pain, Intra-articular, Injection, Corticosteroid

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written consent to participate in the study
Male or female greater than or equal to 40 years of age
Body mass index (BMI) less than or equal to 40 kg/m2
Ambulatory and in good general health
Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions
Willing to abstain from use of protocol-restricted treatments from Screening through End-of-Study visit
Symptoms consistent with OA of the index joint for ≥ 6 months prior to Screening (patient reported is acceptable)
Pain in the index joint for greater than15 days over the last month (as reported by the patient)
For Shoulder OA patients: Radiologic findings of OA of the index shoulder meeting the Samilson-Prieto (S-P) Classification Grades 2 or 3
For Hip OA patients: ACR Criteria (clinical and radiological) for OA of the index hip

Exclusion Criteria:

Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
History of infection in the index joint
Clinical findings consistent with active infection or crystal disease in the index joint within 1 month of Screening
History of fracture in the index limb within 12 months of Screening, or fracture with sequelae at any time
Planned or anticipated surgery of the index joint during the study period
Index joint instability or history of acute dislocation within 12 months of Screening
If shoulder is the index joint, history of full or partial rotator cuff tear or significantly compromised rotator cuff function that, in the opinion for the Investigator, increases the difficulty or risk of IA injection
Presence of surgical hardware or other foreign body in the index joint
Surgery or arthroscopy of the index joint within 12 months of Screening
IA treatment of any joint with any of the following agents within 6 months of Screening:
Any corticosteroid preparation (investigational or marketed, including FX006), any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection; investigational or marketed)
IA treatment of the index joint with hyaluronic acid (investigational or marketed) within 6 months of Screening
Parenteral or oral corticosteroids (investigational or marketed) within 3 months of Screening
Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening
Females who are pregnant or nursing or plan to become pregnant during the study; men who plan to conceive during the study

Sites / Locations

TriWest Research Associates, LLC
Biosolutions Clinical Research Center
Artemis Institute for Clinical Research
LA Biomed at Harbor-UCLA Medical Center
Rochester Clinical Research
Altoona Center for Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FX006 32 mg

TAcs 40 mg

Arm Description

Single intra-articular (IA) injection of FX006 32 mg

Single intra-articular (IA) injection of TAcs 40 mg

Outcomes

Primary Outcome Measures

Concentration of Triamcinolone Acetonide (TA) in Blood Plasma

Characterize the Pharmacokinetic Profile of FX006 and TCA IR [Time Frame: Day 1 (pre-treatment,1, 2, 3, 4, 5, 6, 8,10, and 12 hrs. post-dose) and Days 2, 3, 5, 8, 15, 22, 29, 57,and 85] For the PK analysis and individual concentration vs. time plots, a concentration that is BLOQ is assigned a value of zero if it occurs in a profile before the first measurable concentration. If a BLOQ value occurs after a measurable concentration in a profile and is followed by a value above the lower limit of quantification, then the BLOQ is treated as missing data. If a BLOQ value occurs at the end of the collection interval (after the last quantifiable concentration) it is set to zero. If two BLOQ values occur in succession after Cmax, the profile is deemed to have terminated at the first BLOQ value and any subsequent concentrations are set to zero for PK calculations

Total Number of Treatment Emergent Adverse Events

Analyses of adverse events (AE) were performed for events considered treatment-emergent (TE). TE was defined as any AE with onset after administration of the 1st dose of study drug or any event present at baseline but worsened in intensity through the study. Severity was graded by the PI using the Common Terminology Criteria for AEs Version 4.0. Grading went from Grade 1 (Mild) to Grade 5 (Death Related to AE).

Secondary Outcome Measures

Full Information

NCT ID

NCT03382262

First Posted

December 6, 2017

Last Updated

November 20, 2019

Sponsor

Flexion Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03382262

Brief Title

Study to Compare Exposure of TA Following Administration of FX006 or TAcs in Patients With OA of the Shoulder or Hip

Official Title

A Randomized, Open-label Study Comparing the Systemic Exposure to Triamcinolone Acetonide Following a Single Intra-articular Dose of Extended-release FX006 or Immediate-release TAcs (Triamcinolone Acetonide Suspension) in Patients With Osteoarthritis of the Shoulder (Glenohumeral Joint) or Hip

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

December 18, 2017 (Actual)

Primary Completion Date

October 9, 2018 (Actual)

Study Completion Date

October 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Flexion Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is an open-label study to compare systemic exposure to triamcinolone acetonide following a dose of extended-release FX006 or immediate-release TAcs (triamcinolone acetonide suspension) in patients with osteoarthritis of the shoulder (glenohumeral joint) or hip

Detailed Description

This is a randomized, open-label, single dose study that will be conducted in male and female patients ≥40 years of age with OA of either the shoulder or the hip. Approximately 24 patients with OA of the shoulder and approximately 24 patients with OA of the hip will be randomized to one of two treatment groups (1:1) and treated with a single IA injection of either: 32 mg FX006 (approximately 12 patients per joint) or 40 mg TAcs (approximately 12 patients per joint) Each patient will be screened to confirm the diagnosis of OA of either the shoulder or hip and eligibility based on the other inclusion/exclusion requirements and will be randomized to treatment on Day 1. Each patient will be evaluated for a total of 12 weeks following the IA injection. Following screening, sampling for pharmacokinetics (PK) and safety will be completed at 10 out-patient visits scheduled on Study Days 1 [calendar day of injection], 2, 3, 5, 8, 15, 22, 29, 57, and 85.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis of the Shoulder, Osteoarthritis of the Hip

Keywords

Osteoarthritis, Shoulder, Hip, Pain, Intra-articular, Injection, Corticosteroid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FX006 32 mg

Arm Type

Experimental

Arm Description

Single intra-articular (IA) injection of FX006 32 mg

Arm Title

TAcs 40 mg

Arm Type

Active Comparator

Arm Description

Single intra-articular (IA) injection of TAcs 40 mg

Intervention Type

Drug

Intervention Name(s)

FX006 32 mg

Other Intervention Name(s)

Zilretta

Intervention Description

Extended-release 32 mg FX006 IA injection

Intervention Type

Drug

Intervention Name(s)

TAcs 40 mg

Other Intervention Name(s)

Kenalog®-40 Injection, Triamcinolone Acetonide Crystalline Suspension (TAcs), TCA-IR 40

Intervention Description

Immediate-release 40mg TAcs IA injection

Primary Outcome Measure Information:

Title

Concentration of Triamcinolone Acetonide (TA) in Blood Plasma

Description

Time Frame

12 Weeks

Title

Total Number of Treatment Emergent Adverse Events

Description

Time Frame

12 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written consent to participate in the study Male or female greater than or equal to 40 years of age Body mass index (BMI) less than or equal to 40 kg/m2 Ambulatory and in good general health Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions Willing to abstain from use of protocol-restricted treatments from Screening through End-of-Study visit Symptoms consistent with OA of the index joint for ≥ 6 months prior to Screening (patient reported is acceptable) Pain in the index joint for greater than15 days over the last month (as reported by the patient) For Shoulder OA patients: Radiologic findings of OA of the index shoulder meeting the Samilson-Prieto (S-P) Classification Grades 2 or 3 For Hip OA patients: ACR Criteria (clinical and radiological) for OA of the index hip Exclusion Criteria: Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease History of infection in the index joint Clinical findings consistent with active infection or crystal disease in the index joint within 1 month of Screening History of fracture in the index limb within 12 months of Screening, or fracture with sequelae at any time Planned or anticipated surgery of the index joint during the study period Index joint instability or history of acute dislocation within 12 months of Screening If shoulder is the index joint, history of full or partial rotator cuff tear or significantly compromised rotator cuff function that, in the opinion for the Investigator, increases the difficulty or risk of IA injection Presence of surgical hardware or other foreign body in the index joint Surgery or arthroscopy of the index joint within 12 months of Screening IA treatment of any joint with any of the following agents within 6 months of Screening: Any corticosteroid preparation (investigational or marketed, including FX006), any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection; investigational or marketed) IA treatment of the index joint with hyaluronic acid (investigational or marketed) within 6 months of Screening Parenteral or oral corticosteroids (investigational or marketed) within 3 months of Screening Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening Females who are pregnant or nursing or plan to become pregnant during the study; men who plan to conceive during the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott Kelley, MD

Organizational Affiliation

Flexion Therapeutics, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

TriWest Research Associates, LLC

City

El Cajon

State/Province

California

ZIP/Postal Code

92020

Country

United States

Facility Name

Biosolutions Clinical Research Center

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

Artemis Institute for Clinical Research

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

LA Biomed at Harbor-UCLA Medical Center

City

Torrance

State/Province

California

ZIP/Postal Code

90509

Country

United States

Facility Name

Rochester Clinical Research

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35258839

Citation

Kivitz A, Mehra P, Hanson P, Kwong L, Cinar A, Lufkin J, Kelley S. A Randomized, Open-Label, Single-Dose Study to Assess Safety and Systemic Exposure of Triamcinolone Acetonide Extended-Release in Patients With Hip Osteoarthritis. Rheumatol Ther. 2022 Apr;9(2):679-691. doi: 10.1007/s40744-022-00430-3. Epub 2022 Mar 8.

Results Reference

derived

PubMed Identifier

34350546

Citation

Hanson P, Kivitz A, Mehra P, Kwong L, Cinar A, Lufkin J, Kelley SD. Safety and Systemic Exposure of Triamcinolone Acetonide Following Ultrasound-Guided Intra-Articular Injection of Triamcinolone Extended-Release or Standard Triamcinolone Acetonide in Patients with Shoulder Osteoarthritis: An Open-Label, Randomized Study. Drugs R D. 2021 Sep;21(3):285-293. doi: 10.1007/s40268-021-00348-1. Epub 2021 Aug 4.

Results Reference

derived

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Study to Compare Exposure of TA Following Administration of FX006 or TAcs in Patients With OA of the Shoulder or Hip

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