chronic osteoarthritic knee-joint pain MedDRA version: 20.0 Level: PT Classification code 10031161 Term: Osteoarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Mestex
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent • Otherwise healthy (or with stable medical conditions) men or women with knee osteoarthritis aged between 45 and 75 years (extremes included). • At least 40 mm on motion and at least 10 mm at rest on the 100 mm-VAS (Visual Analog Scale) for average osteoarthritic joint pain in the knee to be studied during the last 2 days, with or without pain medication. • Previous assessment (e.g. radiography, MRI or arthroscopy) showing a Kellgren Lawrence Grade 2 – 4 severity. • Female patients of childbearing potential or female partners of childbearing potential of male patients must agree to use a reliable contraceptive method for at least three months after the injection of MTX-071. • Subject is highly likely to comply with the protocol and complete the study. 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 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: • Previous exposure to the study drug of the target knee. • Any contra-indication as per summary of product characteristic for the premedication used for the concerning patient • Surgery of the target knee within 6 months before study start or planned for any time during the next 6 months. • Any injection into the knee to be studied within the preceding month or trauma to the knee not yet healed. • History of uncontrolled cardiovascular, renal, and/or other disease or malignancy. • History of severe allergic or anaphylactic reactions. • Pregnancy or wanting to become pregnant during the study. • Major bleeding disorder encompassing, but not limited to coagulopathy and any current antithrombotic and anticoagulant. Low dose acetylsalicylic acid for cardiovascular prevention can be allowed in consultation with the medical monitor. • Clinically significant (upon the discretion of the investigator) deviation from the normal laboratory values. • Clinically significant (at the discretion of the investigator) abnormal ECG. • History of drug/chemical/ substance/alcohol abuse within the past 2 years prior to screening. • Significant (upon the discretion of the investigator) symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within the past 2 weeks prior to study medication administration. • Patients positive for human immunodeficiency virus (HIV) antibody, hepatitis C antibody, or for hepatitis B virus surface antigen (HBsAg). • Patients who had a corticosteroid injection in the knee to be studied within 3 months prior to baseline or are planned to get a corticosteroid injection within 4 weeks following the injection of MTX-071. • Systemic (except inhaled) immunosuppressant agent within 6 months prior to study medication administration. • Experimental agent within 30 days or ten half-lives, whichever is longer, prior to study medication administration. • Any other condition, which in the opinion of the investigator, precludes the subject’s participation in the trial. • Patients who are dependent on the sponsor or investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to document the safety and tolerability of intra-articular injections of low doses of MTX-071 based on the incidence, nature and severity of AES /SAEs potentially causally related with the study medication.;Secondary Objective: • to document the pain-relieving effect (based on VAS) and its duration, • to investigate the pain-relieving effect (based on WOMAC score) and its duration. ;Primary end point(s): Occurence of adverse events.;Timepoint(s) of evaluation of this end point: Continuous assessment up to 6 months after injection. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and efficacy endpoints.;Timepoint(s) of evaluation of this end point: during the trial | — |
Countries
Belgium
Contacts
Public ContactKristof Lesneuck
SGS Belgium NV - Life Science Services
Outcome results
None listed