Clinical trial NCT05248386: Efficacy and Safety of RTX-GRT7039 in Adult Subjects With Knee Osteoarthritis
Official title: A Randomized, Double-blind, Placebo-controlled, Phase III Trial to Evaluate the Efficacy and Safety of Intra-articular Injections of RTX-GRT7039 in Adult Subjects With Pain Associated With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Knee,
osteoarthritis
pain assessment
Lead sponsor: Grünenthal GmbH
Sponsor class: INDUSTRY
First posted: 2022-02-21
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A double-blind, randomized, placebo-controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of repeated injections of RTX-GRT7039 versus placebo 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 52 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 from any cause other than osteoarthritis, including referred pain, bursitis, or tendonitis.
* The participant has clinical hip osteoarthritis on the side of the index knee.
* The participant has pre-existing osteonecrosis, subchondral insufficiency fracture, atrophic osteoarthritis, severe bone on bone osteoarthritis, knee pain attributable to disease other than osteoarthritis, or the participant has rapidly progressing osteoarthritis (RPOA) Type I or Type II.
* 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 X-ray 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 efficacy or safety assessments, or any other reason which, in the investigator's opinion, 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.

Primary outcomes:
measure: Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
timeFrame: Baseline up to Week 12
Secondary outcomes:
measure: Change from Baseline in WOMAC Pain Subscale Score
timeFrame: From Baseline up to Week 52
measure: Change from Baseline in WOMAC Physical Function Subscale Score
timeFrame: From Baseline up to Week 52
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From Baseline up to Week 52
measure: Change from Baseline in WOMAC Stiffness Subscale Score
timeFrame: From Baseline up to Week 52
measure: Change from Baseline in WOMAC Total Score
timeFrame: From Baseline up to Week 52
measure: Change from Baseline in WOMAC A1 (Walking Pain) Subscale Score
timeFrame: From Baseline up to Week 52
measure: Percentage of Participants With at Least 30% and 50% Reduction From Baseline in WOMAC Pain Subscale Score
timeFrame: From Baseline up to Week 52
measure: Percentage of Participants With at Least 30% and 50% Reduction From Baseline in WOMAC A1 (Walking Pain) Subscale Score
timeFrame: From Baseline up to Week 52
measure: Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
timeFrame: From Baseline up to Week 52
measure: Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score
timeFrame: From Baseline up to Week 52
measure: Change From Baseline in EuroQol-5 Dimension Health Questionnaire 5 Levels (EQ-5D-5L) Score
timeFrame: From Baseline up to Week 52
measure: Change From Baseline in 36-Item Short-Form (SF-36) Domain Scores
timeFrame: From Baseline up to Week 52
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: Cook Street Medical Clinic
state: British Columbia
city: Victoria
country: Canada
facility: Dr. M. B. Jones
state: British Columbia
city: Brampton
country: Canada
facility: Aggarwal and Associates Limited
state: Ontario
city: Mississauga
country: Canada
facility: Malton Medical Research
state: Ontario
city: Sainte-Foy
country: Canada
facility: GRMO (Groupe de Recherche en Rhumatologie et Maladies Osseuses) Inc.
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
city: Victoriaville
country: Canada
facility: Diex Recherche Victoriaville Inc.
state: Quebec
city: Pisek
country: Czechia
facility: Lekarna U Svate Anny
state: Czech Republic
city: Breclav
country: Czechia
facility: Interni A Revmatologicka Ambulance
city: Brno
country: Czechia
facility: Revmatologie s.r.o.
city: Ostrava
country: Czechia
facility: Vesalion s.r.o.
city: Ostrava
country: Czechia
facility: Revmatologicka Ambulance
city: Pisek
country: Czechia
facility: Ortopedicko-traumatologicka ambulance
city: Prague 4
country: Czechia
facility: Revmatologicka ambulance
city: Praha 3
country: Czechia
facility: CCBR Czech Prague, s.r.o
city: Praha 3
country: Czechia
facility: CCR Prague, s.r.o
city: Praha 4
country: Czechia
facility: Revmatologicka ambulance
city: Praha 4
country: Czechia
facility: Thomayerova Nemocnice (TN)
city: Praha 4
country: Czechia
facility: Fakultni Thomayerova nemocnice s poliklinikou
city: Praha 5
country: Czechia
facility: EUC Klinika
city: Pribram
country: Czechia
facility: Db Ortopedie s.r.o
city: Zlin
country: Czechia
facility: PV-MEDICAL s.r.o. Revmatologicka ambulance
city: Amiens Cedex 1
country: France
facility: CHU Amiens Nord
city: Amiens
country: France
facility: Centre Hospitalier Universitaire d'Amiens-Picardie - Site Sud
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Nîmes
country: France
facility: CHU Nimes Cedex
city: Paris
country: France
facility: Hopital Saint antoine
city: Paris
country: France
facility: Cochin Hospital-Paris Descartes University
city: Paris
country: France
facility: Hopitaux de Paris (AP-HP) - Groupe Hospitalier Cochin -Assistance Publique
city: Paris
country: France
facility: Hopital Lariboisiere,Hospitalier Universitaire Nord
city: Eichstätt
country: Germany
facility: Praxis Dr. med. Stephan Grunert
city: Essen
country: Germany
facility: Medizentrum Essen Borbeck
city: Hamburg
country: Germany
facility: HRF Hamburger Rheuma Forschungszentrum
city: Karlsruhe
country: Germany
facility: Ortho-Zentrum Karlsruhe
city: Leipzig
country: Germany
facility: Velocity Clinical Research Leipzig GmbH
city: Leipzig
country: Germany
facility: AmBeNet, Practice Dr. Dr. med. Hans-Detlev Stahl
city: Muenchen
country: Germany
facility: Centrum fuer Diagnostik und Gesundheit (CDG)
city: Reinfeld
country: Germany
facility: Praxis-Reinfeld-Mitte
city: Firenze
country: Italy
facility: AOU-Careggi
city: Firenze
country: Italy
facility: AOU-Careggi
city: Naples
country: Italy
facility: Universita degli Studi della Campania Luigi Vanvitelli - Azienda Ospedaliera Universitaria
city: Napoli
country: Italy
facility: Dipartimento Di Scienze Ortopediche, Traumatologiche, Riabilitative E Plastico-Ricostruttive
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas
city: Torino
country: Italy
facility: AOU Citta della Salute e della Scienza di Torino
city: Funabashi-shi
country: Japan
facility: Funabashi Municipal Medical Center
state: Chiba
city: Kamagaya
country: Japan
facility: Kamagaya General Hospital
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Hamanomachi Hospital
state: Fukuoka-ken
city: Fukuoka-shi
country: Japan
facility: Souseikai Fukuoka Mirai Hospital
state: Fukuoka-Ken
city: Mihara-shi
country: Japan
facility: Kosei General Hospital
state: Hiroshima-ken
city: Mihara
country: Japan
facility: Kosei General Hospital
state: Hiroshima-ken
city: Hiroshima-shi
country: Japan
facility: Seiwa-kai medical corporation Hiroshima clinic
state: Hiroshima
city: Hakodate
country: Japan
facility: Hakodate Central General Hospital
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Sapporo Maruyama Orthopedic Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: KKR Sapporo Medical Center
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo kotoni Orthopedies
state: Hokkaido
city: Takamatsu-shi
country: Japan
facility: Kinashi Obayashi Hospital
state: Kagawa
city: Yokohama-city
country: Japan
facility: Japan Organization of Occupational Health and Safety Yokohama Rosai Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohoma Rosai Hospital
state: Kanagawa
city: Nagano
country: Japan
facility: Social Medical Care Corporation Hosei-kai Marunouchi Hospital
state: Matsumoto-shi Nagano
city: Sendai-shi
country: Japan
facility: KKR Tohoku Kosai Hospital
state: Miyagi
city: Sendai
country: Japan
facility: Nakajo Orthopedic Clinic
state: Miyagi
city: Matsumoto
country: Japan
facility: Marunouchi Hospital
state: Nagano
city: Aoba-ku
country: Japan
facility: KKR Tohoku Kosai Hospital
state: Sendai-shi
city: Otsu
country: Japan
facility: Otsu City Hospital
state: Shiga
city: Izumo
country: Japan
facility: Shimane University Hospital
state: Shimane
city: Izumo
country: Japan
facility: Shimane University Hospital
state: Shimane
city: Hamamatsu-shi
country: Japan
facility: Japanese Red Cross Hamamatsu Hospital
state: Shizuoka-ken
city: Bunkyo-Ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Juntendo University Graduate School of Medicine
state: Tokyo
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
state: Tokyo
city: Nishimura
country: Japan
facility: Shirahama Hamayu Hospital
state: Wakayama-ken
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Tokyo
country: Japan
facility: Medical Corporation Teda Ooimachi Orthopaedic Surgery and Surgery Clinic
city: Cuauhtemoc
country: Mexico
facility: Clinstile, S.A. de C.V
state: Ciudad De Mexico
city: Gustavo A. Madero
country: Mexico
facility: Consultorio de Reumatologia
state: Distrito Federal
city: Mexico
country: Mexico
facility: CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.
state: Distrito Federal
city: León
country: Mexico
facility: Morales Vargas Centro de Investigacion SC
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Centro Integral en Reumatologia, SA de CV
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Dr. Miguel Cortes Hernandez MD, Office of
state: Morelos
city: Culiacan
country: Mexico
facility: Centro de Investigacion de Tratamientos Innovadores de Sinaloa S.C.
state: Sinaloa
city: Chihuahua
country: Mexico
facility: Investigacion y Biomedicina de Chihuahua
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente (MST) - Enschede Haaksbergerstraat
state: KZ
city: Beek
country: Netherlands
facility: PT&R
state: Limburg
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis (Kennemer Gasthuis)
city: Lublin
country: Poland
facility: Reumed Spolka z o.o. Zespol poradni Specjalistycznych Filia Nr 1 Wallenroda
state: Lubelskie
city: Zamosc
country: Poland
facility: KO-MED Centra Kliniczne Lublin II
state: Lubelskie
city: Krakow
country: Poland
facility: Pratia MCM Krakow
state: Malopolskie
city: Nadarzyn
country: Poland
facility: Makmed Nzoz
state: Mazowieckie
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica MAK-MED S.C.
state: Mazowieckie
city: Bialystok
country: Poland
facility: Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
state: Podlaskie
city: Gdansk
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdansku
state: Pomorskie
city: Poznan
country: Poland
facility: Synexus Poznan Medical Center
state: Wielkopolskie
city: Bialystok
country: Poland
facility: INTER CLINIC Piotr Adrian Klimiuk
city: Gdynia
country: Poland
facility: Synexus Gdynia
city: Grodzisk Mazowiecki
country: Poland
facility: Mazowieckie Centrum Badan Klinicznych
city: Katowice
country: Poland
facility: Synexus Katowice Medical Center
city: Katowice
country: Poland
facility: Centrum Medyczne Pratia Katowice
city: Krakow
country: Poland
facility: Malopolskie Centrum Kliniczne
city: Krakow
country: Poland
facility: St Centrum Medyczne Plejady
city: Lodz
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Lodzi
city: Lublin
country: Poland
facility: KO-MED Centra Kliniczne Lublin II
city: Wroclaw
country: Poland
facility: Synexus Polska Spolka z ograniczona odpowiedzialnoscia Oddzial we Wroclawiu
city: Zamosc
country: Poland
facility: Centrum Medyczne Kuba-Med Zamosc
Study officials:
References: