Intra-articular Lopain (MTX-071) Phase I/IIa Study in Chronic Osteoarthritic Knee Joint Pain
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: open label, single arm Open label, single arm, dose escalating |
Drug: Lopain
intra-articular injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Written informed consent
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Written informed consent
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Men or women aged between 40 and 70 years
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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.
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Previously documented radiography showing a Kellgren Lawrence Grade 2 - 4 severity.
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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.
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Subject is highly likely to comply with the protocol and complete the study.
Exclusion Criteria:
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Knee surgery within 6 months before study start or planned for any time during the next 6 months.
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Any injection into the knee to be studied within the preceding 7 days or trauma to the knee not yet healed.
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History of any clinically significant cardiac, renal, and/or other relevant disease or malignancy.
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History of severe allergic or anaphylactic reactions.
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Pregnancy.
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Major bleeding disorder.
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Clinically significant deviation from the normal laboratory values.
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Clinically significant abnormal ECG
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History of clinically relevant drug/chemical/ substance/alcohol abuse within the past 2 years prior to screening.
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Symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within the past 2 weeks prior to study medication administration.
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Patients positive for human immunodeficiency virus (HIV) antibody, hepatitis C antibody, or for hepatitis B virus surface antigen (HBsAg), tuberculosis.
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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.
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Vaccination within 60 days prior to study medication administration.
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Systemic immunosuppressant agent within 6 months prior to study medication administration
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Experimental agent within 30 days or ten half-lives, whichever is longer, prior to study medication administration.
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Any other condition, which in the opinion of the investigator, precludes the subject's participation in the trial.
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Patients who are dependent on the sponsor or investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SGS Antwerpen | Antwerpen | Belgium |
Sponsors and Collaborators
- Grünenthal GmbH
Investigators
- Principal Investigator: Steven Ramael, SGS Antwerpen, Belgium
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MTX-071-P01