Efficacy and Safety of RTX-GRT7039 in Adult Subjects With Knee Osteoarthritis
- Registration Number
- NCT05248386
- Lead Sponsor
- GrĂ¼nenthal GmbH
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RTX-GRT7039 RTX-GRT7039 Participants will receive intra-articular injections of RTX-GRT7039 during the 52-week double-blind treatment period. Placebo Placebo Participants will receive intra-articular injections of placebo matching to RTX-GRT7039 during the 52-week double-blind treatment period.
- Primary Outcome Measures
Name Time Method Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Baseline up to Week 12 The WOMAC pain subscale will be assessed using an 11-point numeric rating scale (NRS), where 0= no pain and 10=worst pain imaginable.
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment Emergent Adverse Events (TEAEs) From Baseline up to Week 52 Change from Baseline in WOMAC A1 (Walking Pain) Subscale Score From Baseline up to Week 52 The WOMAC A1 subscale will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain imaginable.
Percentage of Participants With at Least 30% and 50% Reduction From Baseline in WOMAC Pain Subscale Score From Baseline up to Week 52 The WOMAC pain subscale will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain imaginable.
Percentage of Participants With at Least 30% and 50% Reduction From Baseline in WOMAC A1 (Walking Pain) Subscale Score From Baseline up to Week 52 The WOMAC A1 subscale will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain imaginable.
Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score From Baseline up to Week 52 The 7-point PGIC is a complementary assessment of analgesic efficacy on a 7-point scale where 1 = "Very much improved" and 7 = "Very much worse".
Change from Baseline in WOMAC Pain Subscale Score From Baseline up to Week 52 The WOMAC pain subscale will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain imaginable.
Change from Baseline in WOMAC Physical Function Subscale Score From Baseline up to Week 52 The WOMAC physical function subscale will be assessed using 11-point NRS, where 0= no pain and 10=worst pain imaginable.
Change from Baseline in WOMAC Total Score From Baseline up to Week 52 The WOMAC total score will be calculated as the sum of pain subscale score, stiffness subscale score and physical function subscale score. It will be calculated by averaging all of the scores available for the questions and assessed using an 11-point NRS, where 0= no pain and 10=worst pain imaginable.
Change from Baseline in WOMAC Stiffness Subscale Score From Baseline up to Week 52 The WOMAC stiffness subscale will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain imaginable.
Change From Baseline in EuroQol-5 Dimension Health Questionnaire 5 Levels (EQ-5D-5L) Score From Baseline up to Week 52 EQ-5D consists of EQ-5D descriptive system (Index score) and EQ visual analogue scale (VAS). EQ-5D-5L Index Score ranges from 0 to 1, with 0 representing death and 1.0 representing perfect health. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that range from where 0 (worst imaginable) to 100 (best imaginable).
Change From Baseline in 36-Item Short-Form (SF-36) Domain Scores From Baseline up to Week 52 The SF-36 domain scores ranged from 0 (worst value) to 100 (best value), with higher scores reflecting better health status.
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response From Baseline up to Week 52 OMERACT-OARSI response: A high improvement of \>=50% (percentage change) and \>=2 (absolute change) in either the WOMAC pain subscale score or WOMAC physical function subscale score, OR An improvement in at least 2 of the following 3:
* Improvement of \>=20% (percentage change) and \>=1 (absolute change) in the WOMAC pain subscale score.
* Improvement of \>=20% (percentage change) and \>=1 (absolute change) in the WOMAC physical function subscale score.
* Improvement of \>=20% (percentage change) and \>=10 (absolute change) in Patient Global Assessment (PGA) of osteoarthritis. Absolute values will be normalized to the 0 (no pain) to 100 scale (higher pain/difficulty).
Trial Locations
- Locations (96)
Makmed Nzoz
đŸ‡µđŸ‡±Nadarzyn, Mazowieckie, Poland
Hopital Edouard Herriot
đŸ‡«đŸ‡·Lyon, France
CHU Nimes Cedex
đŸ‡«đŸ‡·NĂ®mes, France
Hopital Saint antoine
đŸ‡«đŸ‡·Paris, France
Cochin Hospital-Paris Descartes University
đŸ‡«đŸ‡·Paris, France
Hopitaux de Paris (AP-HP) - Groupe Hospitalier Cochin -Assistance Publique
đŸ‡«đŸ‡·Paris, France
Hopital Lariboisiere,Hospitalier Universitaire Nord
đŸ‡«đŸ‡·Paris, France
Praxis Dr. med. Stephan Grunert
đŸ‡©đŸ‡ªEichstätt, Germany
NZOZ Lecznica MAK-MED S.C.
đŸ‡µđŸ‡±Nadarzyn, Mazowieckie, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdansku
đŸ‡µđŸ‡±Gdansk, Pomorskie, Poland
Synexus Poznan Medical Center
đŸ‡µđŸ‡±Poznan, Wielkopolskie, Poland
Synexus Gdynia
đŸ‡µđŸ‡±Gdynia, Poland
Mazowieckie Centrum Badan Klinicznych
đŸ‡µđŸ‡±Grodzisk Mazowiecki, Poland
Synexus Katowice Medical Center
đŸ‡µđŸ‡±Katowice, Poland
Centrum Medyczne Pratia Katowice
đŸ‡µđŸ‡±Katowice, Poland
Malopolskie Centrum Kliniczne
đŸ‡µđŸ‡±Krakow, Poland
St Centrum Medyczne Plejady
đŸ‡µđŸ‡±Krakow, Poland
Synexus Polska Sp. z o.o. Oddzial w Lodzi
đŸ‡µđŸ‡±Lodz, Poland
Synexus Polska Spolka z ograniczona odpowiedzialnoscia Oddzial we Wroclawiu
đŸ‡µđŸ‡±Wroclaw, Poland
Centrum Medyczne Kuba-Med Zamosc
đŸ‡µđŸ‡±Zamosc, Poland
Fakultni Thomayerova nemocnice s poliklinikou
đŸ‡¨đŸ‡¿Praha 4, Czechia
EUC Klinika
đŸ‡¨đŸ‡¿Praha 5, Czechia
PV-MEDICAL s.r.o. Revmatologicka ambulance
đŸ‡¨đŸ‡¿Zlin, Czechia
CHU Amiens Nord
đŸ‡«đŸ‡·Amiens Cedex 1, France
Centre Hospitalier Universitaire d'Amiens-Picardie - Site Sud
đŸ‡«đŸ‡·Amiens, France
KO-MED Centra Kliniczne Lublin II
đŸ‡µđŸ‡±Lublin, Poland
Diex Research Sherbrooke Inc.
đŸ‡¨đŸ‡¦Sherbrooke, Quebec, Canada
Diex Recherche Victoriaville Inc.
đŸ‡¨đŸ‡¦Victoriaville, Quebec, Canada
Lekarna U Svate Anny
đŸ‡¨đŸ‡¿Pisek, Czech Republic, Czechia
Db Ortopedie s.r.o
đŸ‡¨đŸ‡¿Pribram, Czechia
Ortho-Zentrum Karlsruhe
đŸ‡©đŸ‡ªKarlsruhe, Germany
Universita degli Studi della Campania Luigi Vanvitelli - Azienda Ospedaliera Universitaria
đŸ‡®đŸ‡¹Naples, Italy
Dipartimento Di Scienze Ortopediche, Traumatologiche, Riabilitative E Plastico-Ricostruttive
đŸ‡®đŸ‡¹Napoli, Italy
IRCCS Istituto Clinico Humanitas
đŸ‡®đŸ‡¹Rozzano, Italy
AOU Citta della Salute e della Scienza di Torino
đŸ‡®đŸ‡¹Torino, Italy
Interni A Revmatologicka Ambulance
đŸ‡¨đŸ‡¿Breclav, Czechia
PT&R
đŸ‡³đŸ‡±Beek, Limburg, Netherlands
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
đŸ‡µđŸ‡±Bialystok, Podlaskie, Poland
INTER CLINIC Piotr Adrian Klimiuk
đŸ‡µđŸ‡±Bialystok, Poland
Cook Street Medical Clinic
đŸ‡¨đŸ‡¦Victoria, British Columbia, Canada
Revmatologie s.r.o.
đŸ‡¨đŸ‡¿Brno, Czechia
Dr. M. B. Jones
đŸ‡¨đŸ‡¦Victoria, British Columbia, Canada
Aggarwal and Associates Limited
đŸ‡¨đŸ‡¦Brampton, Ontario, Canada
Malton Medical Research
đŸ‡¨đŸ‡¦Mississauga, Ontario, Canada
GRMO (Groupe de Recherche en Rhumatologie et Maladies Osseuses) Inc.
đŸ‡¨đŸ‡¦Sainte-Foy, Quebec, Canada
Vesalion s.r.o.
đŸ‡¨đŸ‡¿Ostrava, Czechia
Revmatologicka Ambulance
đŸ‡¨đŸ‡¿Ostrava, Czechia
Ortopedicko-traumatologicka ambulance
đŸ‡¨đŸ‡¿Pisek, Czechia
Revmatologicka ambulance
đŸ‡¨đŸ‡¿Praha 4, Czechia
CCBR Czech Prague, s.r.o
đŸ‡¨đŸ‡¿Praha 3, Czechia
CCR Prague, s.r.o
đŸ‡¨đŸ‡¿Praha 3, Czechia
Thomayerova Nemocnice (TN)
đŸ‡¨đŸ‡¿Praha 4, Czechia
Kosei General Hospital
đŸ‡¯đŸ‡µMihara, Hiroshima-ken, Japan
Seiwa-kai medical corporation Hiroshima clinic
đŸ‡¯đŸ‡µHiroshima-shi, Hiroshima, Japan
Hakodate Central General Hospital
đŸ‡¯đŸ‡µHakodate, Hokkaido, Japan
Medizentrum Essen Borbeck
đŸ‡©đŸ‡ªEssen, Germany
HRF Hamburger Rheuma Forschungszentrum
đŸ‡©đŸ‡ªHamburg, Germany
Velocity Clinical Research Leipzig GmbH
đŸ‡©đŸ‡ªLeipzig, Germany
Sapporo Maruyama Orthopedic Hospital
đŸ‡¯đŸ‡µSapporo-shi, Hokkaido, Japan
KKR Sapporo Medical Center
đŸ‡¯đŸ‡µSapporo, Hokkaido, Japan
AmBeNet, Practice Dr. Dr. med. Hans-Detlev Stahl
đŸ‡©đŸ‡ªLeipzig, Germany
Centrum fuer Diagnostik und Gesundheit (CDG)
đŸ‡©đŸ‡ªMuenchen, Germany
Praxis-Reinfeld-Mitte
đŸ‡©đŸ‡ªReinfeld, Germany
AOU-Careggi
đŸ‡®đŸ‡¹Firenze, Italy
Funabashi Municipal Medical Center
đŸ‡¯đŸ‡µFunabashi-shi, Chiba, Japan
Kamagaya General Hospital
đŸ‡¯đŸ‡µKamagaya, Chiba, Japan
Hamanomachi Hospital
đŸ‡¯đŸ‡µFukuoka-shi, Fukuoka-ken, Japan
Souseikai Fukuoka Mirai Hospital
đŸ‡¯đŸ‡µFukuoka-shi, Fukuoka-Ken, Japan
Sapporo kotoni Orthopedies
đŸ‡¯đŸ‡µSapporo, Hokkaido, Japan
Kinashi Obayashi Hospital
đŸ‡¯đŸ‡µTakamatsu-shi, Kagawa, Japan
Japan Organization of Occupational Health and Safety Yokohama Rosai Hospital
đŸ‡¯đŸ‡µYokohama-city, Kanagawa, Japan
Yokohoma Rosai Hospital
đŸ‡¯đŸ‡µYokohama, Kanagawa, Japan
Social Medical Care Corporation Hosei-kai Marunouchi Hospital
đŸ‡¯đŸ‡µNagano, Matsumoto-shi Nagano, Japan
Pratia MCM Krakow
đŸ‡µđŸ‡±Krakow, Malopolskie, Poland
KKR Tohoku Kosai Hospital
đŸ‡¯đŸ‡µAoba-ku, Sendai-shi, Japan
Nakajo Orthopedic Clinic
đŸ‡¯đŸ‡µSendai, Miyagi, Japan
Marunouchi Hospital
đŸ‡¯đŸ‡µMatsumoto, Nagano, Japan
Otsu City Hospital
đŸ‡¯đŸ‡µOtsu, Shiga, Japan
Shimane University Hospital
đŸ‡¯đŸ‡µIzumo, Shimane, Japan
Japanese Red Cross Hamamatsu Hospital
đŸ‡¯đŸ‡µHamamatsu-shi, Shizuoka-ken, Japan
Juntendo University Hospital
đŸ‡¯đŸ‡µTokyo, Japan
Juntendo University Graduate School of Medicine
đŸ‡¯đŸ‡µBunkyo-ku, Tokyo, Japan
Kitasato University Kitasato Institute Hospital
đŸ‡¯đŸ‡µMinato-ku, Tokyo, Japan
Shirahama Hamayu Hospital
đŸ‡¯đŸ‡µNishimura, Wakayama-ken, Japan
Medical Corporation Teda Ooimachi Orthopaedic Surgery and Surgery Clinic
đŸ‡¯đŸ‡µTokyo, Japan
Clinstile, S.A. de C.V
đŸ‡²đŸ‡½Cuauhtemoc, Ciudad De Mexico, Mexico
Consultorio de Reumatologia
đŸ‡²đŸ‡½Gustavo A. Madero, Distrito Federal, Mexico
CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.
đŸ‡²đŸ‡½Mexico, Distrito Federal, Mexico
Morales Vargas Centro de Investigacion SC
đŸ‡²đŸ‡½LeĂ³n, Guanajuato, Mexico
Centro Integral en Reumatologia, SA de CV
đŸ‡²đŸ‡½Guadalajara, Jalisco, Mexico
Dr. Miguel Cortes Hernandez MD, Office of
đŸ‡²đŸ‡½Cuernavaca, Morelos, Mexico
Centro de Investigacion de Tratamientos Innovadores de Sinaloa S.C.
đŸ‡²đŸ‡½Culiacan, Sinaloa, Mexico
Investigacion y Biomedicina de Chihuahua
đŸ‡²đŸ‡½Chihuahua, Mexico
Medisch Spectrum Twente (MST) - Enschede Haaksbergerstraat
đŸ‡³đŸ‡±Enschede, KZ, Netherlands
Spaarne Gasthuis (Kennemer Gasthuis)
đŸ‡³đŸ‡±Hoofddorp, Netherlands
Reumed Spolka z o.o. Zespol poradni Specjalistycznych Filia Nr 1 Wallenroda
đŸ‡µđŸ‡±Lublin, Lubelskie, Poland