Comparison of a single RTX-GRT7039 and placebo intra-articular injection for pain associated with osteoarthritis of the knee.

Phase 1

• Conditions: Moderate to severe pain associated with osteoarthritis of the knee; MedDRA version: 21.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2021-005020-38-DK
• Lead Sponsor: Grünenthal GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-21
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• = 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

Exclusion Criteria

• 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, severe bone on bone 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Demonstrate the analgesic efficacy of intra-articular RTX-GRT7039 compared with placebo.;Secondary Objective: • Demonstrate the analgesic efficacy of intra-articular RTX-GRT7039 compared with placebo.<br>• Demonstrate the efficacy of intra-articular RTX-GRT7039 on function compared with placebo.<br>• To assess the safety and tolerability of intra-articular RTX-GRT7039.<br><br>;Primary end point(s): 1) Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score in the index knee.;Timepoint(s) of evaluation of this end point: 1) From baseline (assessment at Visit 2) to Visit 5.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Change in WOMAC pain subscale score in the index knee based on the 11-point numeric rating scale (NRS).<br>2) Change in WOMAC physical function subscale score.<br>3) Incidence of treatment-emergent adverse events (TEAEs). Incidence of TEAEs representing structural changes of the knee joint as visualized by the imaging methods assessed by the investigator as clinically relevant (thus constituting an adverse event [AE]) and as at least possibly related to the IMP (and not attributable to the natural progression of the disease in an individual subject).;Timepoint(s) of evaluation of this end point: 1) From baseline (assessment at Visit 2) to Visit 6.<br>2) From baseline (assessment at Visit 2) to Visit 5 to Visit 6.<br>3) From baseline (assessment at Visit 2) to Visit 8 (end of trial).