Efficacy and Safety of RTX-GRT7039 in Adult Subjects With Knee Osteoarthritis
- Registration Number
- NCT05248386
- Lead Sponsor
- Grünenthal 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
- 469
- 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 Least Squares Mean (Standard Error) [LS-mean (SE)] Change From Baseline in WOMAC Pain Subscale Score at Week 12 Baseline up to Week 12 Difference in mean change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score at Week 12 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine).
- Secondary Outcome Measures
Name Time Method LS-mean (SE) Change From Baseline in WOMAC Pain Subscale Score at Week 52 From Baseline up to Week 52 Difference in mean change from baseline in WOMAC pain subscale score at Week 52 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine).
LS-mean (SE) Change From Baseline in WOMAC Pain Subscale Score at Week 26 From Baseline up to Week 26 Difference in mean change from baseline in WOMAC pain subscale score at Week 26 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine).
LS-mean (SE) Change From Baseline in WOMAC Physical Function Subscale Score at Week 52 From Baseline up to Week 52 Difference in mean change from baseline in WOMAC physical function subscale score at Week 26 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine).
LS-mean (SE) Change From Baseline in WOMAC Physical Function Subscale Score at Week 12 From Baseline up to Week 12 Difference in mean change from baseline in WOMAC physical function subscale score at Week 12 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine).
LS-mean (SE) Change From Baseline in WOMAC Physical Function Subscale Score at Week 26 From Baseline up to Week 26 Difference in mean change from baseline in WOMAC physical function subscale score at Week 26 in the index knee using an 11-point (0-10) numeric rating scale (NRS) between RTX-GRT7039 and placebo. The WOMAC pain subscale consists of 5 questions using an 11-point numeric rating scale (NRS, from 0 = no pain to 10 = pain as bad as you can imagine).
Trial Locations
- Locations (96)
Db Ortopedie s.r.o
🇨🇿Pribram, Czechia
Ortho-Zentrum Karlsruhe
🇩🇪Karlsruhe, Germany
Universita degli Studi della Campania Luigi Vanvitelli - Azienda Ospedaliera Universitaria
🇮🇹Naples, Italy
Dipartimento Di Scienze Ortopediche, Traumatologiche, Riabilitative E Plastico-Ricostruttive
🇮🇹Napoli, Italy
IRCCS Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
AOU Citta della Salute e della Scienza di Torino
🇮🇹Torino, Italy
PT&R
🇳🇱Beek, Limburg, Netherlands
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
🇵🇱Bialystok, Podlaskie, Poland
INTER CLINIC Piotr Adrian Klimiuk
🇵🇱Bialystok, Poland
Cook Street Medical Clinic
🇨🇦Victoria, British Columbia, Canada
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