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This is a multicentre, open-label, one-arm Phase II extension study to evaluate the safety and tolerability of MIV-711 in patients with knee joint osteoarthritis (OA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIV-711 | Experimental | MIV-711 for a total of 26 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIV-711 | Drug | MIV-711 administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients |
| Group A: 0-56 weeks; Group B: 0-30 weeks |
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Inclusion Criteria:
- Previously enrolled in the MIV-711-201 study including completion of Visit 8 either by
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Conaghan, Professor | Leeds Institute of Rheumatic and Musculoskeletal Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MC Comac Medical | Sofia | Bulgaria | ||||
| LCC ARENSIA Exploratory Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | Study Group A was recruited from patients treated with 200 mg MIV-711 once daily in Study MIV-711-201 (NCT02705625) and whose symptoms did not clinically significantly deteriorate as defined by an increase in the Numeric Rating Scale (NRS) of ≤2 compared to baseline. Patients in Study Group A continued the same dosing with 200 mg MIV-711 once daily for 26 additional weeks. |
| FG001 | Group B | Study Group B was recruited from patients receiving placebo in Study MIV-711-201 (NCT02705625) having experienced a clinical worsening as defined by an increase in NRS of ≥2 versus baseline. Patients in Study Group B were treated with 200 mg MIV-711 once daily for the next 26 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Study Group A was recruited from patients treated with 200 mg MIV-711 once daily in Study MIV-711-201 and whose symptoms did not clinically significantly deteriorate as defined by an increase in the NRS of ≤2 compared to baseline. Patients in Study Group A continued the same dosing with 200 mg MIV-711 once daily for 26 additional weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients |
| Posted | Count of Participants | Participants | Group A: 0-56 weeks; Group B: 0-30 weeks |
|
Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment), up to 56 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A | Study Group A was recruited from patients treated with 200 mg MIV-711 once daily in Study MIV-711-201 and whose symptoms did not clinically significantly deteriorate as defined by an increase in the NRS of ≤2 compared to baseline. Patients in Study Group A continued the same dosing with 200 mg MIV-711 once daily for 26 additional weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Basse, Cheif Medical Officer | Medivir AB | +46 8 546 831 00 | linda.basse@medivir.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 1, 2016 | Sep 4, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 16, 2018 | Sep 10, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C000632247 | MIV-711 |
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| Tbilisi |
| Georgia |
| PAREXEL Berlin Early Phase Clinical Unit | Berlin | Germany |
| LCC ARENSIA Exploratory Medicine | Chisinau | Moldova |
| BG001 |
| Group B |
Study Group B was recruited from patients receiving placebo in Study MIV-711-201 having experienced a clinical worsening as defined by an increase in NRS of ≥2 versus baseline. Patients in Study Group B were treated with 200 mg MIV-711 once daily for the next 26 weeks. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Group B | Study Group B was recruited from patients receiving placebo in Study MIV-711-201 having experienced a clinical worsening as defined by an increase in NRS of ≥2 versus baseline. Patients in Study Group B were treated with 200 mg MIV-711 once daily for the next 26 weeks. |
|
|
| 0 |
| 46 |
| 2 |
| 46 |
| 13 |
| 46 |
| EG001 | Group B | Study Group B was recruited from patients receiving placebo in Study MIV-711-201 having experienced a clinical worsening as defined by an increase in NRS of ≥2 versus baseline. Patients in Study Group B were treated with 200 mg MIV-711 once daily for the next 26 weeks. | 0 | 4 | 0 | 4 | 2 | 4 |
| Atrial fibrillation | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
|
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
|
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Duodenitis | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Chronic gastritis | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
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| D012216 |
| Rheumatic Diseases |