Back to resultsIntra-articular Lopain (MTX-071) Phase I/IIa Study in Chronic Osteoarthritic Knee Joint Pain
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Lopain
Sponsored by
About this trial
This is an interventional supportive care trial for Osteoarthritis, Knee
Eligibility Criteria
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.
Sites / Locations
- SGS Antwerpen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
open label, single arm
Arm Description
Open label, single arm, dose escalating
Outcomes
Primary Outcome Measures
Intensity and severity of AES/SAEs potentially causally related with the study medication
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
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
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)
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)
per dose level VAS scores on functionality of the knee joint and patients' general feeling of health and estimation of daily life conditions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02566564
Brief Title
Intra-articular Lopain (MTX-071) Phase I/IIa Study in Chronic Osteoarthritic Knee Joint Pain
Official Title
An Open Label, Single Dose, Dose-escalating Phase I/IIa Study to Determine the Safety and Clinical Effects of Intra-articular Injections of Lopain (MTX-071) in Patients With Chronic Osteoarthritic Knee Joint Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grünenthal GmbH
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
open label, single arm
Arm Type
Experimental
Arm Description
Open label, single arm, dose escalating
Intervention Type
Drug
Intervention Name(s)
Lopain
Other Intervention Name(s)
MTX-071
Intervention Description
intra-articular injection
Primary Outcome Measure Information:
Title
Intensity and severity of AES/SAEs potentially causally related with the study medication
Description
overall and per dose level (descriptive statistics) incidence, intensity and severity of AES/SAEs potentially causally related with the study medication
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
pain relief response: overall and dose response
Description
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
Time Frame
up to 6 months
Title
duration of pain relief response: overall and dose response
Description
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
Time Frame
up to 6 months
Title
Acceptance of / satisfaction with treatment as stated by the patients and physicians. (VAS score)
Description
per dose level VAS score on acceptance of / satisfaction with treatment as stated by the patients and physicians.
Time Frame
up to 6 months
Title
Influence of treatment on functionality of the knee joint and patients' general feeling of health and estimation of daily life conditions (VAS scores)
Description
per dose level VAS scores on functionality of the knee joint and patients' general feeling of health and estimation of daily life conditions
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Ramael
Organizational Affiliation
SGS Antwerpen, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
SGS Antwerpen
City
Antwerpen
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Intra-articular Lopain (MTX-071) Phase I/IIa Study in Chronic Osteoarthritic Knee Joint Pain
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