A randomized, double-blind, placebo-controlled, Phase III trial to evaluate the efficacy and safety of a single intra-articular injection of RTX-GRT7039 in adult subjects with pain associated with osteoarthritis of the knee.

Grünenthal GmbH0 个研究点目标入组 450 人开始时间: 2022年4月28日最近更新: 2022年8月8日

研究概览

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•= 18 years of age at the screening visit.
•Body Mass Index (BMI) = 40.0 kg/m2.
•Diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria and functional capacity class of I-III.
•Moderate to severe osteoarthritis at baseline.
•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 180
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 270

•The subject had an intra-articular injection of either corticosteroid or intra-articular visco-supplementation (i.e., hyaluronic acid) into the index knee within 3 months.
•The subject had an injection of platelet-rich plasma into the index knee within 6 months.
•The subject applied topical capsaicin on the index knee within 3 months.
•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.

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