Chronic osteoarthritic knee-joint pain MedDRA version: 20.0 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859 MedDRA version: 20.0 Level: LLT Classification code 10003244 Term: Arthritic pains System Organ Class: 100000004859 MedDRA version: 20.0 Level: LLT Classification code 10064238 Term: Gonalgia System Organ Class: 100000004859
Conditions
Sponsors
Mestex
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part I: - Written informed consent - Otherwise healthy 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 arthritic joint pain in the knee to be studied during the last 2 days, with or without pain medication. - Previously documented imaging (e.g. radiography or MRI) 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 one month after the injection of MTX-071. - Subject is highly likely to comply with the protocol and complete the study. Part II - Written informed consent (only before the second injection). - Patient has received at least one dose of MTX-071 within 3 to 12 months prior to the planned second administration. - Patient has received at least a second dose of MTX-071 within 3 to 12 months prior to the planned third administration. - Patient did not experience any treatment related SAE. - At least 40 mm on motion on the 100 mm-VAS (Visual Analog Scale) for average arthritic joint pain in the knee to be studied during the last 2 days. - 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 one month 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 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: Part I: - Knee surgery 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 7 days or trauma to the knee not yet healed. - History of any cardiovascular, renal, and/or other relevant disease or malignancy. - History of severe allergic or anaphylactic reactions. - Pregnancy. - Major bleeding disorder. - Clinically significant deviation from the normal laboratory values. - Clinically significant abnormal ECG - History of clinically relevant drug/chemical/ substance/alcohol abuse within the past 2 years prior to screening. - 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. - Vaccination within 60 days prior to study medication administration. - Systemic 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. Part II: - Knee surgery since the first administration until last study visit. - Any injection into the knee to be studied within the preceding 30 days or trauma to the knee not yet healed. - Pregnancy. - Clinically significant abnormal ECG. - Symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within the past 2 weeks prior to study medication administration. - Patients who had a corticosteroid injection in the knee to be studied between first dose of MTX-071 and the next planned dose of MTX-071. - Vaccination within 14 days prior to study medication administration. - Systemic immunosuppressant within the last 6 months prior to the planned administration - Other experimental agent between MTX-071 study medication administrations. - 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: Part I: The primary objective is the safety and tolerability of intra-articular injection of MTX-071 in incrementing doses based on the incidence, nature and severity of AES/SAEs potentially causally related with the study medication. Part II: The primary objective is the safety and tolerability of a second and a third intra-articular injection of MTX-071 on the incidence, nature and severity of AES/SAEs potentially causally related with the study medication. Documentation of safety data will last for at least 90 (±10) days up to a maximum of 180 (±10) days after injection of MTX-071. ;Secondary Objective: Part I: • Pain-relieving effect and its duration • Assessment of a dose-response relationship • Response to treatment defined as more than a 20% decrease from baseline in mm on the VAS for pain on motion without increase in pain medication, as average of either the last two days or the last seven days • Influence of treatment on functionality of the knee joint and patients' general feeling of health and estimation of daily life conditions (WOMAC, SF-12 Health Status Survey) • Use of pain medication • Acceptance of/satisfaction with treatment as stated by the patients and treating physicians Part II: • Pain-relieving effect and its duration • Response to treatment defined as more than a 20% decrease from baseline in mm on the VAS for pain on motion without increase in pain medication, as average of either the last two days or the last seven days. • Use of pain medication • Acceptance of/satisfaction with treatment as stated by the patients and treating physicians. ;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: Part I: 7 days, 30 days, 90 days and 180 days after injection. Part II: 7 days, 30 days, 90 days and 180 days after injection and 60, 120 and 150 days after injection (telephone call with patient) | — |
Countries
Belgium
Contacts
Public ContactKristof Lesneuck
SGS Belgium NV - Life Science Services
Outcome results
None listed