Open-label Trial to Check the Safety and Tolerability of RTX-GRT7039 Injections for Pain Associated With Osteoarthritis of the Knee
- Registration Number
- NCT05377489
- Lead Sponsor
- Grünenthal GmbH
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 930
- 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 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RTX-GRT7039 RTX-GRT7039 Participants will receive injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with highest pain intensity), or each of both knees up to Week 52.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment Emergent Adverse Events (TEAEs) From Baseline up to Week 78
- Secondary Outcome Measures
Name Time Method Change from Baseline in WOMAC A1 (Walking Pain) Score From Baseline up to Week 12 The WOMAC A1 score will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain.
Percentage of Participants With at Least 30%, 50% and 70% Reduction From Baseline in WOMAC Pain Subscale Score From Baseline up to Week 12 The WOMAC pain subscale will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain.
Percentage of Participants With at Least 30%, 50% and 70% Reduction From Baseline in WOMAC A1 (Walking Pain) Score From Baseline up to Week 12 The WOMAC A1 score will be assessed using an 11-point NRS, where 0= no pain and 10=worst pain.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Representing Structural Changes as Assessed by Imaging Methods From Baseline up to Week 78 Change from Baseline in WOMAC Pain Subscale Score From Baseline up to Week 12 The WOMAC pain subscale will be assessed using an 11-point numerical rating scale (NRS), where 0= no pain and 10=worst pain.
Change from Baseline in WOMAC Stiffness Subscale Score From Baseline up to Week 12 The WOMAC stiffness subscale will be assessed using an 11-point NRS, where 0= no stiffness and 10= extreme stiffness.
Change from Baseline in WOMAC Total Score From Baseline up to Week 12 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=best outcome and 10=worst outcome.
Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score From Baseline up to Week 12 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 Physical Function Subscale Score From Baseline up to Week 12 The WOMAC physical function subscale will be assessed using 11-point NRS, where 0= no difficulty and 10=extreme difficulty.
Change From Baseline in EuroQol-5 Dimension Health Questionnaire 5 Levels (EQ-5D-5L) Score From Baseline up to Week 12 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 representing perfect health. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that range from 0 (worst imaginable) to 100 (best imaginable).
Change From Baseline in Patient-Specific Functional Scale (PSFS) From Baseline up to Week 12 The PSFS scale will be assessed using an 11-point NRS, where 0= Unable to perform activity and 10=Able to perform activity at the same level as before your osteoarthritis of the knee started.
Change From Baseline in 36-Item Short-Form (SF-36) Domain Scores From Baseline up to Week 12 The 8 SF-36 domain scores range from 0 (worst value) to 100 (best value), with higher scores reflecting better health status.
Trial Locations
- Locations (91)
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Gulfcoast Research Institute
🇺🇸Sarasota, Florida, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
North Georgia Clinical Research
🇺🇸Woodstock, Georgia, United States
Injury Care Research
🇺🇸Boise, Idaho, United States
Chicago Clinical Research Institute Inc.
🇺🇸Chicago, Illinois, United States
OrthoIndy, Inc.
🇺🇸Greenwood, Indiana, United States
University Of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Neuroscience Research Center, LLC
🇺🇸Overland Park, Kansas, United States
Clinical Pharmacology Study Group
🇺🇸Worcester, Massachusetts, United States
Oakland Medical Research Center
🇺🇸Troy, Michigan, United States
Excel Clinical Research
🇺🇸Las Vegas, Nevada, United States
Las Vegas Clinical Trials, LLC
🇺🇸North Las Vegas, Nevada, United States
Drug Trials America
🇺🇸Hartsdale, New York, United States
M3-Emerging Medical Research, LLC
🇺🇸Raleigh, North Carolina, United States
University Orthopedics Center
🇺🇸State College, Pennsylvania, United States
Coastal Carolina Research Center
🇺🇸North Charleston, South Carolina, United States
Accellacare-Knoxville
🇺🇸Knoxville, Tennessee, United States
Tekton Research, Inc.
🇺🇸San Antonio, Texas, United States
Wasatch Clinical Research
🇺🇸Salt Lake City, Utah, United States
UMHAT Eurohospital Plovdiv OOD
🇧🇬Plovdiv, Bulgaria
Medical Centre Artmed
🇧🇬Plovdiv, Bulgaria
MHAT Kaspela EOOD
🇧🇬Plovdiv, Bulgaria
UMHAT Pulmed
🇧🇬Plovdiv, Bulgaria
University Multiprofile Hospital For Active Treatment Pulmed OOD
🇧🇬Plovdiv, Bulgaria
Medical Centre N. I. Pirogov EOOD
🇧🇬Sofia, Bulgaria
MHAT St Iv. Rilski
🇧🇬Sofia, Bulgaria
UMBAL Sveti Ivan Rilski EAD
🇧🇬Sofia, Bulgaria
Synexus Medical Center Sofia
🇧🇬Sofia, Bulgaria
Multi-Profile District Hospital for Active Treatment Dr. Stefan Cherkezov
🇧🇬Weliko Tarnowo, Bulgaria
Fukuoka University Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Medical Corporation Kouhoukai Takagi Hospital
🇯🇵Okawa-shi, Fukuoka, Japan
Hakodate Central General Hospital
🇯🇵Hakodate, Hokkaido, Japan
Saiseikai Kanagawaken Hospital
🇯🇵Yokohama-shi, Kanagawa, Japan
Otakibashi Orthopedic Clinic
🇯🇵Shinjuku-ku, Tokyo, Japan
Saitama Medical Center
🇯🇵Saitama, Japan
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
🇵🇱Wroclaw, Dolnoslaskie, Poland
Centrum Medyczne 4M Plus
🇵🇱Krakow, Malopolska, Poland
ETG Warszawa
🇵🇱Warszawa, Poland
ClinicMed Badurski I Wspolnicy Spolka Jawna
🇵🇱Bialystok, Poland
ClinicMed Daniluk, Nowak Spolka komandytowa
🇵🇱Bialystok, Poland
Zaklad Opieki Zdrowotnej w Boleslawcu
🇵🇱Boleslawiec, Poland
Centrum Kliniczno
🇵🇱Elblag, Poland
NZOZ Medi Spatz
🇵🇱Gliwice, Poland
PZU Zdrowie S.A. Oddzia¿ Centrum Medyczne Artimed w Kielcach
🇵🇱Kielce, Poland
Centrum Medyczne Semper fortis
🇵🇱Krakow, Poland
Centermed Krakow Sp. z o.o.
🇵🇱Krakow, Poland
Nzoz Centermed Krakow, Szpital I Przychodnia
🇵🇱Krakow, Poland
ETYKA Osrodek Badan Klinicznych
🇵🇱Olsztyn, Poland
Medyczne Centrum Hetmanska Indywidualna Specjalistyczna Praktyka Lekarska Dr Hab Piotr Leszczynski
🇵🇱Poznań, Poland
Medyczne Centrum Hetmanska
🇵🇱Poznań, Poland
RCMed Oddzial Sochaczew
🇵🇱Sochaczew, Poland
RCMed Piotr Opadczuk
🇵🇱Sochaczew, Poland
Lubelskie Centrum Diagnostyczne
🇵🇱Swidnik, Poland
Europejskie Centrum leczenia Chorob Cywilizacyjnych
🇵🇱Warszawa, Poland
Wojewodzki Szpital Zespolony W Kielcach
🇵🇱Kielce, Świętokrzyskie, Poland
Spitalul Judetean Caracal
🇷🇴Caracal, Olt, Romania
SC Medicali's SRL
🇷🇴Timişoara, Timis, Romania
SC Medaudio-Optica SRL
🇷🇴Râmnicu Vâlcea, Valcea, Romania
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL
🇷🇴Brasov, Romania
Spital Clinic Dr I Cantacuzino
🇷🇴Bucharest, Romania
SC Policlinica CCBR SRL
🇷🇴Bucharest, Romania
Sf. Maria Hospital
🇷🇴Bucharest, Romania
SC Centrul Medical Sana SRL
🇷🇴Bucuresti, Romania
Spitalul Clinic Sf. Maria
🇷🇴Bucuresti, Romania
Tread Research
🇿🇦Parow, Cape Town, South Africa
Tygerberg hospital
🇿🇦Parow, Cape Town, South Africa
Josha Research
🇿🇦Bloemfontein, Free State, South Africa
Welkom Clinical Trial Centre
🇿🇦Welkom, Free State, South Africa
Worthwhile Clinical Trials
🇿🇦Benoni, Gauteng, South Africa
Midrand Medical Centre
🇿🇦Halfway House, Gauteng, South Africa
Lakeview Hospital
🇿🇦Johannesburg, Gauteng, South Africa
Global Clinical Trials
🇿🇦Pretoria, Gauteng, South Africa
University of Pretoria
🇿🇦Pretoria, Gauteng, South Africa
Roodepoort Medicross Clinical Research Centre
🇿🇦Roodepoort, Gauteng, South Africa
Sandton Medical Research (Newtown CRC)
🇿🇦Sandton, Gauteng, South Africa
Clinresco Centres (Pty) Ltd.
🇿🇦Kempton Park, Johannesburg, South Africa
Dr Zubar Fazal Ahmed Vawda MD
🇿🇦Durban, Kwa Zulu Natal, South Africa
Synapta Clinical Research Center
🇿🇦Durban, Kwa-Zulu Natal, South Africa
Precise Clinical Solutions
🇿🇦Durban, Kwa-Zulu Natal, South Africa
Aliwal Shoal Medical Centre
🇿🇦Umkomaas, Kwa-Zulu Natal, South Africa
Medicross Langeberg Medical & Dental Centre
🇿🇦Kraaifontein, Western Cape, South Africa
Arthritis Clinical Research Centre
🇿🇦Cape Town, South Africa
Accellacare Yorkshire
🇬🇧Shipley, Yorkshire, United Kingdom
Accellacare Warwickshire
🇬🇧Coventry, United Kingdom
Chapel Allerton Hospital - Leeds Teaching Hospitals NHS Trust
🇬🇧Leeds, United Kingdom
Arizona Arthritis and Rheumatology Associates (AARA) P.C
🇺🇸Glendale, Arizona, United States
Elite Clinical Studies, LLC
🇺🇸Phoenix, Arizona, United States
Orange County Research Institute
🇺🇸Anaheim, California, United States
Acclaim Clinical Research, Inc.
🇺🇸San Diego, California, United States
Westlake Medical Research
🇺🇸Thousand Oaks, California, United States