Trial Outcomes & Findings for A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients (NCT NCT03037489)
NCT ID: NCT03037489
Last Updated: 2019-03-18
Results Overview
1. Number of Participants with Treatment Emergent Adverse Events (TEAEs) 2. Number of Participants with Serious Adverse Events (SAEs) 3. Number of Participants with TEAEs related to treatment 4. Number of Participants with mild TEAEs 5. Number of Participants with moderate TEAEs 6. Number of Participants with severe TEAEs 7. Number of Participants with TEAEs leading to early discontinuation
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Group A: 0-56 weeks; Group B: 0-30 weeks
Results posted on
2019-03-18
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
4
|
|
Overall Study
COMPLETED
|
39
|
4
|
|
Overall Study
NOT COMPLETED
|
7
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients
Baseline characteristics by cohort
| Measure |
Group A
n=46 Participants
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.
|
Group B
n=4 Participants
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.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 7.52 • n=5 Participants
|
65.5 years
STANDARD_DEVIATION 5.51 • n=7 Participants
|
61.8 years
STANDARD_DEVIATION 7.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Moldova
|
21 participants
n=5 Participants
|
3 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Georgia
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
9 participants
n=5 Participants
|
0 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
13 participants
n=5 Participants
|
1 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Group A: 0-56 weeks; Group B: 0-30 weeks1. Number of Participants with Treatment Emergent Adverse Events (TEAEs) 2. Number of Participants with Serious Adverse Events (SAEs) 3. Number of Participants with TEAEs related to treatment 4. Number of Participants with mild TEAEs 5. Number of Participants with moderate TEAEs 6. Number of Participants with severe TEAEs 7. Number of Participants with TEAEs leading to early discontinuation
Outcome measures
| Measure |
Group A
n=46 Participants
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.
|
Group B
n=4 Participants
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.
|
|---|---|---|
|
Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients
TEAEs
|
21 Participants
|
2 Participants
|
|
Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients
SAEs
|
2 Participants
|
0 Participants
|
|
Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients
Related TEAEs
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients
Mild TEAEs
|
6 Participants
|
1 Participants
|
|
Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients
Moderate TEAEs
|
14 Participants
|
1 Participants
|
|
Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients
Severe TEAEs
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients
TEAEs leading to early discontinuation
|
4 Participants
|
0 Participants
|
Adverse Events
Group A
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A
n=46 participants at risk
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.
|
Group B
n=4 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
2.2%
1/46 • Number of events 1 • 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.
|
0.00%
0/4 • 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.
|
|
Cardiac disorders
Atrial fibrillation
|
2.2%
1/46 • Number of events 1 • 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.
|
0.00%
0/4 • 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.
|
|
Cardiac disorders
Cardiac failure
|
2.2%
1/46 • Number of events 1 • 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.
|
0.00%
0/4 • 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.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
2.2%
1/46 • Number of events 1 • 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.
|
0.00%
0/4 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
2.2%
1/46 • Number of events 1 • 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.
|
0.00%
0/4 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
2.2%
1/46 • Number of events 1 • 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.
|
0.00%
0/4 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
2.2%
1/46 • Number of events 1 • 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.
|
0.00%
0/4 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.2%
1/46 • Number of events 1 • 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.
|
0.00%
0/4 • 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.
|
|
Gastrointestinal disorders
Duodenitis
|
2.2%
1/46 • Number of events 1 • 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.
|
0.00%
0/4 • 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.
|
|
Gastrointestinal disorders
Gastritis
|
2.2%
1/46 • Number of events 1 • 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.
|
0.00%
0/4 • 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.
|
Other adverse events
| Measure |
Group A
n=46 participants at risk
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.
|
Group B
n=4 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Headache
|
2.2%
1/46 • Number of events 1 • 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.
|
25.0%
1/4 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Chronic gastritis
|
4.3%
2/46 • Number of events 2 • 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.
|
0.00%
0/4 • 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.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
4.3%
2/46 • Number of events 2 • 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.
|
0.00%
0/4 • 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.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
4.3%
2/46 • Number of events 2 • 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.
|
0.00%
0/4 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
8.7%
4/46 • Number of events 4 • 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.
|
25.0%
1/4 • Number of events 1 • 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.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
2/46 • Number of events 2 • 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.
|
0.00%
0/4 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place