Assessment of Safety and Efficacy of ARTHRUM 2.5% for Tre... | NCT06228274

Studies
Assessment of Safety and Efficacy of ARTHRUM 2.5% for Treatment of Painful Osteoarthritis of the Knee

NCT06228274

Sponsor

LCA Pharmaceutical

Status

Completed

Last Update Posted

Jan 29, 2024Actual

Enrollment

218Actual

Phase

Not provided

Conditions

Knee Osteoarthritis

Interventions

ARTHRUM 2.5%

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Sep 2015Actual

Completion Date

Mar 2017Actual

First Submitted Date

Jul 19, 2016

First Submission Date that Met QC Criteria

Jan 18, 2024

First Posted Date

Jan 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2024

Last Update Posted Date

Jan 29, 2024Actual

Name	Class
BIOSTATEM	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

ARTHRUM 2.5% MONO-INJECTION as symptomatic treatment by joint injection extends the conservative therapeutic arsenal in Knee osteoarthritis.

The reduction of functional limits and disabilities induced by knee osteoarthritis as well as improvement of quality of life of patients is a public health need registered amongst the priorities established by the French law of 9 August 2004 relative to Public Health policy. However, the response to this need is not limited to treatment with health products.

This prospective, open, multi-centre trial of the real-life efficacy of ARTHRUM 2.5% aims to demonstrate the efficacy of a single joint injection of this treatment on pain, during 6 months, in the symptomatic treatment of patients suffering from Knee osteoarthritis

Detailed Description

Parameters used to determine treatment outcomes include: Western Ontario McMaster Universities Osteoarthritis Index (WOMAC Index), Evaluation of Quality of Life and Handicap and Assessment of therapeutic efficacy

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

218Actual

Label	Type	Description	Intervention Names
ARTHRUM 2.5% single injection			Device: ARTHRUM 2.5%

Name	Type	Description	Arm Group Labels	Other Names
ARTHRUM 2.5%	Device	ARTHRUM 2.5%	ARTHRUM 2.5% single injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy of ARTHRUM 2.5% single joint injection on pain assessed by Likert scale on five levels		6 months

Secondary Outcomes

Measure	Description	Time Frame
Safety of ARTHRUM 2.5% under actual conditions of prescription and use: frequency, nature and severity of reported side effects assessed by Likert scale on four levels		6 months
Reduction of consumption of Analgesics and NSAIDs after ARTHRUM 2.5% intra-articular injection assessed by Likert scale on four levels.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men or women aged over 40
Suffering from unilateral knee osteoarthritis confirmed radiologically less than six months ago and stage I, II or III according to KELGREEN (knee in extension) and with minimal pain on walking (WOMAC A1) of two points on the LIKERT scale and functional discomfort for at least three months
Patient able to understand the trial procedure and give his/her consent to take part, in writing
Patient geographically stable during the trial
Patient affiliated to the French social security regime or benefiting from such a French regime.

Exclusion Criteria:

Inflammatory arthritis
Progressive infectious condition of the knee being studied
Previous treatment with viscosupplementation for at least one year
Injection of corticoids into the knee studied for less than three months
Known hypersensitivity to hyaluronic acid or substances with similar activity
Anticoagulant treatment in progress
Insulin-dependent / type I diabetes
Pregnant or breast-feeding women
Patient under guardianship or tutorship or under judicial protection
Patient currently taking part in another clinical research study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Men or women aged over 40
Suffering from knee osteoarthritis

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
DOMINIQUE BARON, MD	Centre de reeducation et de readaptation fonctionnelles en milieu marin de Trestel	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases