Clinical trial NCT02705625: A Study to Evaluate the Efficacy, Safety and Tolerability of MIV-711 in Osteoarthritis Patients
Official title: A Randomised, Double-blind Placebo-controlled Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of MIV-711 in Knee Joint Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Lead sponsor: Medivir
Sponsor class: INDUSTRY
First posted: 2016-03-10
Enrollment: 244
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Numeric Rating Scale (NRS) Average Target Knee Pain Score at Week 26
timeFrame: baseline and 26 weeks
Secondary outcomes:
measure: Magnetic Resonance Imaging (MRI) Bone Area of the Target Knee at Week 26
timeFrame: baseline and 26 weeks
measure: Magnetic Resonance Imaging (MRI) of Cartilage Thickness (Femur) at Week 26
timeFrame: baseline and 26 weeks
measure: Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain Score
timeFrame: baseline and 26 weeks
measure: Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Difficulty Score
timeFrame: baseline and 26 weeks
measure: Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score
timeFrame: baseline and 26 weeks
measure: Serum C-terminal Telopeptide of Collagen Type I (CTX-I) at Week 26
timeFrame: baseline and 26 weeks
measure: Creatinine Corrected Urine C-terminal Telopeptide of Collagen Type II (CTX-II) at Week 26
timeFrame: baseline and 26 weeks
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: MC Comac Medical
city: Tbilisi
country: Georgia
facility: LCC ARENSIA Exploratory Medicine
city: Berlin
country: Germany
facility: PAREXEL Berlin Early Phase Clinical Unit
city: Chisinau
country: Moldova, Republic of
facility: LCC ARENSIA Exploratory Medicine
city: Bucharest
country: Romania
facility: SC ARENSIA Exploratory Medicine SRL
city: Leeds
country: United Kingdom
facility: University of Leeds, Leeds Institute of Rheumatic and Musculoskeletal Medicine
Study officials:
affiliation: Leeds Institute of Rheumatic and Musculoskeletal Medicine
name: Philip Conaghan, Professor
role: PRINCIPAL_INVESTIGATOR
References: