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.

Grunenthal GmbH0 sites30 target enrollmentJuly 18, 2023

Overview

No summary available.

Registry

jrct.mhlw.go.jp

Start Date

July 18, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Assignment

Sex

All

Sponsor

•>=18 years of age at the screening visit.
•Body Mass Index (BMI)=< 40.0 kg/m
•Diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria and functional capacity class of I-III.
•Moderate to severepain due to osteoarthritis of the knee.
•Documented history indicating that subject has insufficient pain relief with optimal standard of care (SoC).
•The investigator does not consider that any additional benefit can reasonably be expected from further adjustments to the patient's pain treatment.

•The subject had an intra-articular injection of either corticosteroid or intra-articular visco-supplementation (i.e., hyaluronic acid) into the index knee within one month.
•The subject had an injection of platelet-rich plasma into the index knee within one month.
•The subject applied topical capsaicin on the index knee within 3months.
•Pre-existing rapidly progressing osteoarthritis (RPOA) Type I or Type II, osteonecrosis, subchondral insufficiency fracture, atrophic osteoarthritis, or the subject has knee pain attributable to disease other than osteoarthritis.
•Other conditions that could confound discrimination of pain assessment in the index knee.
•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 subject's participation in the full duration of the trial.
•History of severe allergic or anaphylactic reactions.
•History of significant trauma or surgery, or surgery planned during the trial period, related to the knee.

Incidence of treatment-emergent adverse events(TETAEs)

Time Frame: From baseline (assessment at Visit 2) to Visit 8 or 9 (end of trial)

Incidence of TETAEs

Incidence of TETAEs leading to discontinuation

Time Frame: From baseline (assessment at Visit 2) to Visit 8 or 9 (end of trial)

Incidence of TETAEs leading to discontinuation

Incidence of TEAEs representing structural changes of the knee joint(From baseline (assessment at Visit 2) to Visit 8 or 9 (end of trial))
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function and pain subscale score(From baseline (assessment at Visit 2) to Visit 5)
Change in QoL as assessed by questionnaires EQ-5D-5L and SF-36(From baseline (assessment at Visit 2) to Visit 5)