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Trial record 35 of 75 for:    "Collagen Disease" | "Triamcinolone"

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

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ClinicalTrials.gov Identifier: NCT03726788
Recruitment Status : Not yet recruiting
First Posted : October 31, 2018
Last Update Posted : May 21, 2019
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Lille Catholic University

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).

Condition or disease Intervention/treatment Phase
Joint Diseases Knee Therapeutics Magnetic Resonance Imaging Drug: Botulinum Toxin Type A 100U Drug: Botulinum Toxin Type A 200U Drug: Triamcinolone Hexacetonide Inj Susp 20 MG/ML Phase 2

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To date, 2 published randomized controlled trials and one unpublished Phase Ib clinical trial have shown that botulinum toxin injected intraarticularly improves pain and functionality in gonarthrosis.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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Only pharmacists and radiologists know the patient's randomizing arm.
Primary Purpose: Treatment
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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox MRI Scans

Arm Intervention/treatment
Experimental: Botulinum Toxin Type A 100U
one intra-articular injection in the painful knee 30 days after the inclusion visit
Drug: Botulinum Toxin Type A 100U
one intra-articular injection of 100 U of botulinum toxin type A, diluted in 2 ml of 0.9% SSI
Other Name: Botox 100 UNT Injection

Experimental: Botulinum Toxin Type A 200U
one intra-articular injection in the painful knee 30 days after the inclusion visit
Drug: Botulinum Toxin Type A 200U
one intra-articular injection of 200 U of botulinum toxin type A, diluted in 4 ml of 0.9% SSI
Other Name: Botox 200 UNT Injection

Active Comparator: Triamcinolone Hexacetonide 20 MG/ML
one intra-articular injection in the painful knee 30 days after the inclusion visit
Drug: Triamcinolone Hexacetonide Inj Susp 20 MG/ML
one intra-articular injection of 2 ml Triamcinolone Hexacetonide
Other Name: HEXATRIONE




Primary Outcome Measures :
  1. 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 Measures :
  1. Pain analysis by the visual analogue scale (VAS) [ Time Frame: during the first 3 months after injection ]
    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])

  2. Joint amplitude measured by goniometry [ Time Frame: at 1, 3, 6 month post-injection ]
    To measure range of motion of the knee

  3. Western Ontario McMaster University Osteoarthritis (WOMAC) Index [ Time Frame: at 1, 3, 6 month post-injection ]
    An arthritic pain scoring system ranging from 0-no pain/disability to 100-most severe pain/disability

  4. Two minutes walk [ Time Frame: at 1, 3, 6 month post-injection ]
    This test measure the distance walked in two minutes

  5. Frequency of consumption of analgesics [ Time Frame: at 1, 3, 6 month post-injection ]
  6. Amount of consumption of analgesics [ Time Frame: at 1, 3, 6 month post-injection ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726788


Contacts
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Contact: Amélie Lansiaux, MD PhD 03 20 22 52 69 ext +33 lansiaux.amelie@ghicl.net
Contact: Anne-Sophie Blain 03 20 22 57 32 ext +33 Blain.Anne-Sophie@ghicl.net

Locations
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France
Lille Catholic University
Lille, France, 59000
Sponsors and Collaborators
Lille Catholic University
Allergan
Investigators
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Principal Investigator: Hichem Khenioui, MD GHICL

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Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT03726788     History of Changes
Other Study ID Numbers: RC-P0037
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lille Catholic University:
knee
Arthrosis
Botulinum toxin
Magnetic Resonance Imaging

Additional relevant MeSH terms:
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Rheumatic Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Joint Diseases
Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis
Arthritis
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Neuromuscular Agents
Peripheral Nervous System Agents