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Intra Articular Injection of Botulinum Toxin Versus Corticoids in Gonarthrosis (TOXART)

Primary Purpose

Joint Diseases, Knee, Therapeutics

Status

Unknown status

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Botulinum Toxin Type A 100U

Botulinum Toxin Type A 200U

Triamcinolone Hexacetonide Inj Susp 20 MG/ML

About this trial

This is an interventional treatment trial for Joint Diseases focused on measuring knee, Arthrosis, Botulinum toxin, Magnetic Resonance Imaging

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Presenting gonarthrosis of degenerative origin, Kellgren/Lawrence Radiological Stage I to III, with a maturity of more than 18 months
With pain intensity greater than or equal to 50/100 on an VAS
In case of bilateral gonarthrosis, the VAS of the contralateral knee must be less than or equal to 30/100
Presenting a failure of conventional per os treatments (non-steroidal anti-inflammatory drugs, analgesics)
Affiliated with a social security scheme
For women of childbearing age:
- effective contraception for the duration of the study

Exclusion Criteria:

Patient presenting at the time of the inclusion visit: an inflammatory attack, septic or inflammatory arthritis, a generalized infectious episode in progress
Local or regional local skin lesion
Need of an arthroplasty within the next 12 months
Having received corticosteroids or other molecules in intra-articular infiltration in the last 6 months
History of traumatic knee injury (bone injury in the past 24 months), bone, ligament or meniscal surgery in the past 24 months
History of disabling peripheral nerve injury
Severe bleeding disorders, anticoagulant treatment in progress or double antiplatelet aggregation
BMI > 35 kg/m2
Coxarthrosis with projected knee pain
Pregnant or breastfeeding woman
Patient under guardianship and protection of justice
Allergy/contraindication to botulinum toxin type A, corticoids
Usual contraindication to MRI
Allergy to the contrast product

Sites / Locations

Lille Catholic University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Botulinum Toxin Type A 100U

Botulinum Toxin Type A 200U

Triamcinolone Hexacetonide 20 MG/ML

Arm Description

one intra-articular injection in the painful knee 30 days after the inclusion visit

Outcomes

Primary Outcome Measures

Assesment of vascularization by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) according to the % Area Under the Curve (AUC) of perfusion value

Secondary Outcome Measures

Pain analysis by the visual analogue scale (VAS)

Evolution kinetics of daily pain collected during the first 3 months post-injection allowing to deduce the onset and duration of analgesic efficacy in number of days. The pain VAS is a continuous scale comprised of a horizontal line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme: "no pain" (score of 0) and "pain as bad as it could be" (score of 100 [100-mm scale])

Joint amplitude measured by goniometry

To measure range of motion of the knee

Western Ontario McMaster University Osteoarthritis (WOMAC) Index

An arthritic pain scoring system ranging from 0-no pain/disability to 100-most severe pain/disability

Two minutes walk

This test measure the distance walked in two minutes

Frequency of consumption of analgesics

Amount of consumption of analgesics

Full Information

NCT ID

NCT03726788

First Posted

October 29, 2018

Last Updated

May 20, 2019

Sponsor

Lille Catholic University

Collaborators

Allergan

1. Study Identification

Unique Protocol Identification Number

NCT03726788

Brief Title

Intra Articular Injection of Botulinum Toxin Versus Corticoids in Gonarthrosis

Acronym

TOXART

Official Title

Analysis of Antalgic Efficacy of an Intra Articular Injection of Botulinum Toxin Versus Corticoids in Gonarthrosis by Perfusion MRI:a Superiority, Randomized, Controlled, Double Blind Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 2019 (Anticipated)

Primary Completion Date

November 2021 (Anticipated)

Study Completion Date

April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lille Catholic University

Collaborators

Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

We believe we can demonstrate a link between the analgesic action of intra-articular injection of botulinum toxin and synovial inflammation by Dynamic Contrast Enhancement (DCE) perfusion Magnetic Resonance Imaging (MRI).

Detailed Description

Knee osteoarthritis is one of the most common causes of joint pain and functional disability in the general population. Intra-articular infiltrations of corticoids are indicated for painful crisis especially if accompanied of effusion. However, this effect lasts only 2 weeks. Given the lack of effective long-term medical-infiltrative treatment, we believe that botulinum toxin type A could be used by its direct action on mediators of neuro-gene inflammation at the joint level and its indirect medullary action by retrograde migration. To date, 2 published randomized controlled trials and one unpublished Phase Ib clinical trial have shown that botulinum toxin injected intraarticularly improves pain and functionality in gonarthrosis. Dynamic Contrast Enhancement (DCE) Magnetic Resonance Imaging (MRI) demonstrated the correlation between synovial inflammation and pain in gonarthrosis in a cohort of 454 subjects. It has also made it possible, via the monitoring of synovial inflammation, to demonstrate the efficacy of treatments in patients suffering from rheumatoid arthritis in the early phase, juvenile chronic arthritis or osteoarthritis. DCE MRI perfusion therefore appears here as the technique of choice to follow the evolution of synovial inflammation after botulinum toxin injection in patients with symptomatic gonarthrosis.

6. Conditions and Keywords

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

Joint Diseases, Knee, Therapeutics, Magnetic Resonance Imaging

Keywords

knee, Arthrosis, Botulinum toxin, Magnetic Resonance Imaging

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Only pharmacists and radiologists know the patient's randomizing arm.

Allocation

Randomized

Enrollment

105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Botulinum Toxin Type A 100U

Arm Type

Experimental

Arm Description

one intra-articular injection in the painful knee 30 days after the inclusion visit

Arm Title

Botulinum Toxin Type A 200U

Arm Type

Experimental

Arm Description

one intra-articular injection in the painful knee 30 days after the inclusion visit

Arm Title

Triamcinolone Hexacetonide 20 MG/ML

Arm Type

Active Comparator

Arm Description

one intra-articular injection in the painful knee 30 days after the inclusion visit

Intervention Type

Drug

Intervention Name(s)

Botulinum Toxin Type A 100U

Other Intervention Name(s)

Botox 100 UNT Injection

Intervention Description

one intra-articular injection of 100 U of botulinum toxin type A, diluted in 2 ml of 0.9% SSI

Intervention Type

Drug

Intervention Name(s)

Botulinum Toxin Type A 200U

Other Intervention Name(s)

Botox 200 UNT Injection

Intervention Description

one intra-articular injection of 200 U of botulinum toxin type A, diluted in 4 ml of 0.9% SSI

Intervention Type

Drug

Intervention Name(s)

Triamcinolone Hexacetonide Inj Susp 20 MG/ML

Other Intervention Name(s)

HEXATRIONE

Intervention Description

one intra-articular injection of 2 ml Triamcinolone Hexacetonide

Primary Outcome Measure Information:

Title

Assesment of vascularization by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) according to the % Area Under the Curve (AUC) of perfusion value

Time Frame

one month post-injection

Secondary Outcome Measure Information:

Title

Pain analysis by the visual analogue scale (VAS)

Description

Time Frame

during the first 3 months after injection

Title

Joint amplitude measured by goniometry

Description

To measure range of motion of the knee

Time Frame