Open-label trial to check the safety and tolerability of RTX-GRT7039injections 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: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2021-005046-15-PL
• Lead Sponsor: Grünenthal GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-24
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 930

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 372
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 558

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 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 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. Presence of these medical conditions has to be evaluated based on medical history and X-ray assessed by Central Readers, performed during Screening.
• 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: To assess the safety and tolerability of intra-articular RTX-GRT7039.;Secondary Objective: • To assess the safety of intra-articular RTX-GRT7039 with regard to structural changes.<br>• Investigate the analgesic effectiveness of intra-articular RTX-GRT7039 - index knee and non-index knee (if applicable).<br>• Evaluate the quality of life after treatment with RTX-GRT7039.;Primary end point(s): 1) Incidence of treatment-emergent adverse events (TEAEs). Incidence of TEAEs leading to discontinuation.;Timepoint(s) of evaluation of this end point: 1) From baseline (assessment at Visit 2) to Visit 8 or 9 (end of trial).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Incidence of TEAEs representing structural changes of the knee joint as visualized by the imaging methods (X-ray and/or magnetic resonance imaging [MRI].<br>2) Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function and pain subscale score for the index and the non-index (where applicable) knee. <br>3) Change in QoL as assessed by questionnaires EQ-5D-5L and SF-36<br>;Timepoint(s) of evaluation of this end point: 1) From baseline (assessment at Visit 2) to Visit 8 or 9 (end of trial).<br>2) From baseline (assessment at Visit 2) to Visit 5.<br>3) From baseline (assessment at Visit 2) to Visit 5.