Clinical trial NCT05377489: Open-label Trial to Check the Safety and Tolerability of RTX-GRT7039 Injections for Pain Associated With Osteoarthritis of the Knee
Official title: A Single-arm, Open-label, Phase III Trial to Evaluate the Safety and Tolerability of Intra-articular Injections of RTX-GRT7039 in Subjects With Moderate to Severe Pain Associated With Osteoarthritis of the Knee.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Knee
Osteoarthritis
Pain assessment
Lead sponsor: Grünenthal GmbH
Sponsor class: INDUSTRY
First posted: 2022-05-17
Enrollment: 930
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label, single-arm clinical trial to confirm the safety of monoarticular injections or bi-lateral intra-articular injections of RTX-GRT7039 in patients who have pain associated with osteoarthritis of the knee despite standard of care.

Detailed description: This trial comprises a total observation period of up to 78 weeks.

Eligibility criteria: Inclusion Criteria:

* The participant has given written informed consent to participate.
* The participant is 18 years of age or older at the Screening Visit.
* The participant has a diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria and functional capacity class of I to III.
* There is a documented history indicating that participant has insufficient pain relief with previous Standard of Care.

Exclusion Criteria:

* The participant has past joint replacement surgery of the index knee.
* The participant has a history of significant trauma or surgery (e.g., open or arthroscopic) to the index knee within 12 months of Screening.
* The participant has periarticular pain at the index knee from any cause other than osteoarthritis, including referred pain, bursitis, tendonitis.
* The participant has clinical hip osteoarthritis on the side of the index knee.
* The participant has a history of osteonecrosis, subchondral insufficiency fracture, atrophic osteoarthritis, rapidly progressing osteoarthritis (RPOA) Type I or Type II,pathologic fracture, primary or metastatic tumor, or joint infection in the index knee.
* The participant has significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the target knee (varus \>10°, valgus \>10°) by radiograph as assessed by independent Central Readers at Screening Visit.
* The participant has other conditions that could affect trial endpoint assessments of the index knee.
* The participant has current clinically significant disease(s) or condition(s) that may affect safety assessments, or any other reason which may preclude the participant's participation for the full duration of the trial.
* The participant has a history of hypersensitivity to resiniferatoxin (RTX) or any similar component (capsaicin, chili peppers).
* The participant is currently participating or was participating in another investigational drug trial within 3 months prior to the Screening Visit.
* The participant is an employee of the investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial site or is a family member of the employees or the investigator.

The non-index knee is not eligible for treatment in the trial, if any of the knee-related exclusion criteria applies to the non-index knee.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From Baseline up to Week 78
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Representing Structural Changes as Assessed by Imaging Methods
timeFrame: From Baseline up to Week 78
measure: Change from Baseline in WOMAC Pain Subscale Score
timeFrame: From Baseline up to Week 12
measure: Change from Baseline in WOMAC Physical Function Subscale Score
timeFrame: From Baseline up to Week 12
measure: Change from Baseline in WOMAC Stiffness Subscale Score
timeFrame: From Baseline up to Week 12
measure: Change from Baseline in WOMAC A1 (Walking Pain) Score
timeFrame: From Baseline up to Week 12
measure: Change from Baseline in WOMAC Total Score
timeFrame: From Baseline up to Week 12
measure: Percentage of Participants With at Least 30%, 50% and 70% Reduction From Baseline in WOMAC Pain Subscale Score
timeFrame: From Baseline up to Week 12
measure: Percentage of Participants With at Least 30%, 50% and 70% Reduction From Baseline in WOMAC A1 (Walking Pain) Score
timeFrame: From Baseline up to Week 12
measure: Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score
timeFrame: From Baseline up to Week 12
measure: Change From Baseline in Patient-Specific Functional Scale (PSFS)
timeFrame: From Baseline up to Week 12
measure: Change From Baseline in EuroQol-5 Dimension Health Questionnaire 5 Levels (EQ-5D-5L) Score
timeFrame: From Baseline up to Week 12
measure: Change From Baseline in 36-Item Short-Form (SF-36) Domain Scores
timeFrame: From Baseline up to Week 12
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Arizona Arthritis and Rheumatology Associates (AARA) P.C
state: Arizona
city: Phoenix
country: United States
facility: Elite Clinical Studies, LLC
state: Arizona
city: Anaheim
country: United States
facility: Orange County Research Institute
state: California
city: San Diego
country: United States
facility: Acclaim Clinical Research, Inc.
state: California
city: Thousand Oaks
country: United States
facility: Westlake Medical Research
state: California
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Sarasota
country: United States
facility: Gulfcoast Research Institute
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Boise
country: United States
facility: Injury Care Research
state: Idaho
city: Chicago
country: United States
facility: Chicago Clinical Research Institute Inc.
state: Illinois
city: Greenwood
country: United States
facility: OrthoIndy, Inc.
state: Indiana
city: Kansas City
country: United States
facility: University Of Kansas Medical Center
state: Kansas
city: Overland Park
country: United States
facility: Neuroscience Research Center, LLC
state: Kansas
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Troy
country: United States
facility: Oakland Medical Research Center
state: Michigan
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: North Las Vegas
country: United States
facility: Las Vegas Clinical Trials, LLC
state: Nevada
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: Durham
country: United States
facility: M3-Emerging Medical Research, LLC
state: North Carolina
city: Raleigh
country: United States
facility: M3-Emerging Medical Research, LLC
state: North Carolina
city: State College
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Knoxville
country: United States
facility: Accellacare-Knoxville
state: Tennessee
city: San Antonio
country: United States
facility: Tekton Research, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: Plovdiv
country: Bulgaria
facility: UMHAT Eurohospital Plovdiv OOD
city: Plovdiv
country: Bulgaria
facility: Medical Centre Artmed
city: Plovdiv
country: Bulgaria
facility: MHAT Kaspela EOOD
city: Plovdiv
country: Bulgaria
facility: UMHAT Pulmed
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital For Active Treatment Pulmed OOD
city: Sofia
country: Bulgaria
facility: Medical Centre N. I. Pirogov EOOD
city: Sofia
country: Bulgaria
facility: MHAT St Iv. Rilski
city: Sofia
country: Bulgaria
facility: UMBAL Sveti Ivan Rilski EAD
city: Sofia
country: Bulgaria
facility: Synexus Medical Center Sofia
city: Weliko Tarnowo
country: Bulgaria
facility: Multi-Profile District Hospital for Active Treatment Dr. Stefan Cherkezov
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital
state: Fukuoka
city: Okawa-shi
country: Japan
facility: Medical Corporation Kouhoukai Takagi Hospital
state: Fukuoka
city: Hakodate
country: Japan
facility: Hakodate Central General Hospital
state: Hokkaido
city: Yokohama-shi
country: Japan
facility: Saiseikai Kanagawaken Hospital
state: Kanagawa
city: Shinjuku-ku
country: Japan
facility: Otakibashi Orthopedic Clinic
state: Tokyo
city: Saitama
country: Japan
facility: Saitama Medical Center
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
state: Dolnoslaskie
city: Krakow
country: Poland
facility: Centrum Medyczne 4M Plus
state: Malopolska
city: Warsaw
country: Poland
facility: ETG Warszawa
state: Mazowieckie
city: Bialystok
country: Poland
facility: ClinicMed Badurski I Wspolnicy Spolka Jawna
city: Bialystok
country: Poland
facility: ClinicMed Daniluk, Nowak Spolka komandytowa
city: Boleslawiec
country: Poland
facility: Zaklad Opieki Zdrowotnej w Boleslawcu
city: Elblag
country: Poland
facility: Centrum Kliniczno
city: Gliwice
country: Poland
facility: NZOZ Medi Spatz
city: Kielce
country: Poland
facility: PZU Zdrowie S.A. Oddzia¿ Centrum Medyczne Artimed w Kielcach
city: Krakow
country: Poland
facility: Centrum Medyczne Semper fortis
city: Krakow
country: Poland
facility: Centermed Krakow Sp. z o.o.
city: Krakow
country: Poland
facility: Nzoz Centermed Krakow, Szpital I Przychodnia
city: Olsztyn
country: Poland
facility: ETYKA Osrodek Badan Klinicznych
city: Poznań
country: Poland
facility: Medyczne Centrum Hetmanska Indywidualna Specjalistyczna Praktyka Lekarska Dr Hab Piotr Leszczynski
city: Poznań
country: Poland
facility: Medyczne Centrum Hetmanska
city: Sochaczew
country: Poland
facility: RCMed Oddzial Sochaczew
city: Sochaczew
country: Poland
facility: RCMed Piotr Opadczuk
city: Swidnik
country: Poland
facility: Lubelskie Centrum Diagnostyczne
city: Warszawa
country: Poland
facility: ETG Warszawa
city: Warszawa
country: Poland
facility: Europejskie Centrum leczenia Chorob Cywilizacyjnych
city: Warszawa
country: Poland
facility: ETG Warszawa
city: Kielce
country: Poland
facility: Wojewodzki Szpital Zespolony W Kielcach
state: Świętokrzyskie
city: Caracal
country: Romania
facility: Spitalul Judetean Caracal
state: Olt
city: Timişoara
country: Romania
facility: SC Medicali's SRL
state: Timis
city: Râmnicu Vâlcea
country: Romania
facility: SC Medaudio-Optica SRL
state: Valcea
city: Brasov
country: Romania
facility: Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL
city: Bucharest
country: Romania
facility: Spital Clinic Dr I Cantacuzino
city: Bucharest
country: Romania
facility: SC Policlinica CCBR SRL
city: Bucharest
country: Romania
facility: Sf. Maria Hospital
city: Bucuresti
country: Romania
facility: SC Centrul Medical Sana SRL
city: Bucuresti
country: Romania
facility: Spitalul Clinic Sf. Maria
city: Parow
country: South Africa
facility: Tread Research
state: Cape Town
city: Parow
country: South Africa
facility: Tygerberg hospital
state: Cape Town
city: Bloemfontein
country: South Africa
facility: Josha Research
state: Free State
city: Welkom
country: South Africa
facility: Welkom Clinical Trial Centre
state: Free State
city: Benoni
country: South Africa
facility: Worthwhile Clinical Trials
state: Gauteng
city: Halfway House
country: South Africa
facility: Midrand Medical Centre
state: Gauteng
city: Johannesburg
country: South Africa
facility: Lakeview Hospital
state: Gauteng
city: Pretoria
country: South Africa
facility: Global Clinical Trials
state: Gauteng
city: Pretoria
country: South Africa
facility: University of Pretoria
state: Gauteng
city: Roodepoort
country: South Africa
facility: Roodepoort Medicross Clinical Research Centre
state: Gauteng
city: Sandton
country: South Africa
facility: Sandton Medical Research (Newtown CRC)
state: Gauteng
city: Kempton Park
country: South Africa
facility: Clinresco Centres (Pty) Ltd.
state: Johannesburg
city: Durban
country: South Africa
facility: Dr Zubar Fazal Ahmed Vawda MD
state: Kwa Zulu Natal
city: Durban
country: South Africa
facility: Synapta Clinical Research Center
state: Kwa-Zulu Natal
city: Durban
country: South Africa
facility: Precise Clinical Solutions
state: Kwa-Zulu Natal
city: Umkomaas
country: South Africa
facility: Aliwal Shoal Medical Centre
state: Kwa-Zulu Natal
city: Kraaifontein
country: South Africa
facility: Medicross Langeberg Medical & Dental Centre
state: Western Cape
city: Kraaifontein
country: South Africa
facility: Medicross Langeberg Medical & Dental Centre
state: Western Cape
city: Cape Town
country: South Africa
facility: Arthritis Clinical Research Centre
city: Shipley
country: United Kingdom
facility: Accellacare Yorkshire
state: Yorkshire
city: Coventry
country: United Kingdom
facility: Accellacare Warwickshire
city: Leeds
country: United Kingdom
facility: Chapel Allerton Hospital - Leeds Teaching Hospitals NHS Trust
Study officials:
References: