Osteoarthritis, KneePhase 2NCT02705625
A Study to Evaluate the Efficacy, Safety and Tolerability of MIV-711 in Osteoarthritis Patients
A Phase 2 study testing MIV-711 in people with Osteoarthritis, Knee, run by Medivir at 6 sites in 6 countries.
Trial summary
This is a multicentre, randomised, placebo-controlled, double-blind, three-arm parallel, Phase IIa study to evaluate the efficacy, safety and tolerability of MIV-711 in patients with knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- MIV-711
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 244 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 28 Jan 2016to 23 May 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current average knee pain, defined as pain in either knee, within 1 week before visit 1, for which the patient gives a severity score of ≥4, <10 on a 0-10 NRS (Numeric Rating Scale).
- Inclusive of 40-80 years old.
- Diagnosis of primary knee osteoarthritis
Who cannot join
- The presence of any inflammatory arthritis
- Any generalized pain condition that may interfere with the evaluation of the target knee pain (e.g., fibromyalgia) as judged by the investigator.
- Any clinically severe or significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair ability to give informed consent or take part in or complete this clinical study.
- Known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
United Kingdom1 site
University of Leeds, Leeds Institute of Rheumatic and Musculoskeletal Medicine
Leeds
About this study
Official title: A Randomised, Double-blind Placebo-controlled Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of MIV-711 in Knee Joint Osteoarthritis
This is a multicentre, randomised, placebo-controlled, double-blind, three-arm parallel, Phase IIa study to evaluate the efficacy, safety and tolerability of MIV-711 in patients with knee osteoarthritis (OA).
- Conditions
- Osteoarthritis, Knee
- Being tested
- MIV-711, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIV-711Drug
MIV-711 administered orally once daily
PlaceboDrug
Placebo manufactured to mimic MIV-711 capsule.
| Study group | Role | What they receive |
|---|---|---|
| MIV-711:1 | Experimental | MIV-711 for a total of 26 w Receives: Drug: MIV-711 |
| MIV-711:2 | Experimental | MIV-711 for a total of 26 w Receives: Drug: MIV-711 |
| Placebo | Placebo comparator | Placebo for a total of 26 w Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS) Average Target Knee Pain Score at Week 26
Change from Visit 2 (Baseline) to Visit 8 (Week 26) in NRS average target knee pain score.
NRS (Numeric rating scale) ranges from 0 indicating -"no pain", to 10 indicating - "pain as bad as it could be".
Measured: baseline and 26 weeks
Secondary outcomes (7)
Magnetic Resonance Imaging (MRI) Bone Area of the Target Knee at Week 26
Change from Visit 2 (Baseline) to Visit 8 (Week 26) in MRI (Magnetic Resonance Imaging;) bone area of the target knee in mm^2.
Measured: baseline and 26 weeks
Magnetic Resonance Imaging (MRI) of Cartilage Thickness (Femur) at Week 26
Change from Visit 2 (baseline) to Visit 8 (week 26) in MRI cartilage thickness in the Central Medial Femur Region of the target knee in mm.
Measured: baseline and 26 weeks
Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain Score
Change from Visit 2 (Baseline) to Visit 8 (Week 26) in normalised WOMAC pain score. The WOMAC responses are scored using an 11-point NRS where 0=none and 10=extreme. There are 5 questions in the WOMAC pain scale which is summed up for the total WOMAC score, leading to a range of 0 to 50. The total WOMAC pain score has been standardised to a scale with a range from 0 to 100 (where 100 is extreme pain):
- Normalised WOMAC pain score = Total WOMAC pain score multiplicated with 2.
Measured: baseline and 26 weeks
Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Difficulty Score
Change from Visit 2 (Baseline) to Visit 8 (Week 26) in normalised WOMAC difficulty score. The WOMAC responses are scored using an 11-point NRS where 0=none and 10=extreme. There are 17 questions in the WOMAC difficulty scale which is summed up for the total WOMAC difficulty score, leading to a range of 0 to 170. The total WOMAC difficulty score has been standardised to a scale with a range from 0 to 100 (where 100 is extreme pain):
- Normalised WOMAC difficulty score = Total WOMAC difficulty score divided with 1.7
Measured: baseline and 26 weeks
Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score
Change from Visit 2 (Baseline) to Visit 8 (Week 26) in normalised WOMAC stiffness score. The WOMAC responses are scored using an 11-point NRS where 0=none and 10=extreme. There are 2 questions in the WOMAC stiffness scale which is summed up for the total WOMAC stiffness score, leading to a range of 0 to 20. The total WOMAC stiffness score has been standardised to a scale with a range from 0 to 100 (where 100 is extreme pain):
- Normalised WOMAC stiffness score = Total WOMAC stiffness score multiplicated with 5
Measured: baseline and 26 weeks
Serum C-terminal Telopeptide of Collagen Type I (CTX-I) at Week 26
Change from Visit 2 (baseline) to Visit 8 (week 26) in serum CTX-I, a biomarker for bone resorption.
Measured: baseline and 26 weeks
Creatinine Corrected Urine C-terminal Telopeptide of Collagen Type II (CTX-II) at Week 26
Change from Visit 2 (baseline) to Visit 8 (week 26) in creatinine corrected urine CTX-II, a biomarker for cartilage degradation.
Measured: baseline and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study start28 Jan 2016
- Primary completion23 May 2017
- Study completion23 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medivir
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Conaghan, Professor, Principal investigator, Leeds Institute of Rheumatic and Musculoskeletal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705625
- Sponsor's protocol ID
- MIV-711-201
- Status last verified
- Mar 2019
- First submitted
- 7 Mar 2016
- Last updated
- 17 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind Placebo-controlled Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of MIV-711 in Knee Joint Osteoarthritis
- ClinicalTrials.gov ID
- NCT02705625
- Acronym / sponsor ID
- MIV-711-201
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- MedivirIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2016 (actual)
- Primary completion
- 23 May 2017 (actual)
- Study completion
- 23 May 2017 (actual)
- First posted
- 10 Mar 2016 (estimated)
- Results
- Posted 17 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicentre, randomised, placebo-controlled, double-blind, three-arm parallel, Phase IIa study to evaluate the efficacy, safety and tolerability of MIV-711 in patients with knee osteoarthritis (OA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MIV-711:1 | Experimental | Drug: MIV-711MIV-711 for a total of 26 w |
| MIV-711:2 | Experimental | Drug: MIV-711MIV-711 for a total of 26 w |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for a total of 26 w |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Current average knee pain, defined as pain in either knee, within 1 week before visit 1, for which the patient gives a severity score of ≥4, <10 on a 0-10 NRS (Numeric Rating Scale).
- Inclusive of 40-80 years old.
- Diagnosis of primary knee osteoarthritis
Key exclusion criteria (4 listed)
- The presence of any inflammatory arthritis
- Any generalized pain condition that may interfere with the evaluation of the target knee pain (e.g., fibromyalgia) as judged by the investigator.
- Any clinically severe or significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair ability to give informed consent or take part in or complete this clinical study.
- Known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIV-711MIV-711 administered orally once daily | Drug | MIV-711:1, MIV-711:2 |
| PlaceboPlacebo manufactured to mimic MIV-711 capsule. | Drug | Placebo |
Primary outcome
Numeric Rating Scale (NRS) Average Target Knee Pain Score at Week 26
Time frame: baseline and 26 weeks
Change from Visit 2 (Baseline) to Visit 8 (Week 26) in NRS average target knee pain score. NRS (Numeric rating scale) ranges from 0 indicating -"no pain", to 10 indicating - "pain as bad as it could be".
7 secondary outcomes
Magnetic Resonance Imaging (MRI) Bone Area of the Target Knee at Week 26
Time frame: baseline and 26 weeks
Magnetic Resonance Imaging (MRI) of Cartilage Thickness (Femur) at Week 26
Time frame: baseline and 26 weeks
Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain Score
Time frame: baseline and 26 weeks
Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Difficulty Score
Time frame: baseline and 26 weeks
Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score
Time frame: baseline and 26 weeks
Serum C-terminal Telopeptide of Collagen Type I (CTX-I) at Week 26
Time frame: baseline and 26 weeks
Creatinine Corrected Urine C-terminal Telopeptide of Collagen Type II (CTX-II) at Week 26
Time frame: baseline and 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Conaghan, Professor principal investigator
Leeds Institute of Rheumatic and Musculoskeletal Medicine
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MIV-711 in people with Osteoarthritis, Knee, run by Medivir at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Bulgaria, Georgia, Germany, Moldova, Romania and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (NRS) Average Target Knee Pain Score at Week 26 (time frame: baseline and 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2019; AzTrials last refreshed its copy on 31 Oct 2026.