Osteoarthritis, Knee
Conditions
Brief summary
Phase I/IIa study to determine the safety and clinical effects of intra-articular injections of MTX-071 (Lopain) in patients with chronic osteoarthritic knee-joint pain.
Detailed description
Open label, single-dose, dose-escalating phase I/IIa study to determine the safety and clinical effects of intra-articular injections of MTX-071 (Lopain) in patients with chronic osteoarthritic knee-joint pain.
Interventions
DRUGLopain
intra-articular injection
Sponsors
Grünenthal GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Written informed consent * Men or women aged between 40 and 70 years * 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 radiography 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.
Exclusion criteria
* 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 clinically significant cardiac, 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), tuberculosis. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensity and severity of AES/SAEs potentially causally related with the study medication | up to 6 months | overall and per dose level (descriptive statistics) incidence, intensity and severity of AES/SAEs potentially causally related with the study medication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain relief response: overall and dose response | up to 6 months | overall and per dose level percentage of patients overall percentage of patients with pain relief response to single intraarticular administration of Lopain (MTX-071) defined as more than a 20% decrease from baseline in mm on the VAS for pain on motion without increase in pain medication |
| duration of pain relief response: overall and dose response | up to 6 months | overall and per dose level intra-patients maintenance at 7 days, 1, 3 and 6 months of the pain relief response defined as more than a 20% decrease from baseline in mm on the VAS for pain on motion without increase in pain medication |
| Acceptance of / satisfaction with treatment as stated by the patients and physicians. (VAS score) | up to 6 months | per dose level VAS score on acceptance of / satisfaction with treatment as stated by the patients and physicians. |
| Influence of treatment on functionality of the knee joint and patients' general feeling of health and estimation of daily life conditions (VAS scores) | up to 6 months | per dose level VAS scores on functionality of the knee joint and patients' general feeling of health and estimation of daily life conditions |
Countries
Belgium
Outcome results
None listed