Osteoarthritis, Knee Clinical Trial
— FORWARDOfficial title:
A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Trial to Investigate the Efficacy and Safety of Different Intra Articular (i.a.) Dosages of Sprifermin in Subjects With Primary Osteoarthritis of the Knee
Verified date | June 2020 |
Source | EMD Serono |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial of Sprifermin administered intra-articularly in participants with primary osteoarthritis of the knee and Kellgren-Lawrence Grade 2 or 3. The trial was intended to investigate the efficacy and safety of different intra articular dosages of Sprifermin in these individuals.
Status | Completed |
Enrollment | 549 |
Est. completion date | May 7, 2019 |
Est. primary completion date | May 5, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Age from 40 to 85 years; of either sex - Primary femorotibial osteoarthritis according to American College of Rheumatology (ACR) clinical and radiographic criteria , and meeting protocol-specified X-ray criteria in the target knee at screening - Pain score in the target knee and/or the need for regular symptomatic treatment of knee pain with paracetamol (acetaminophen), systemic non-steroidal anti-inflammatory drugs (NSAIDs) including cyclooxygenase (COX)-2 selective inhibitors (coxibs), or tramadol on most days in the previous month (that is, more than half of the days in the previous month) - A history of pain due to Osteoarthritis in the target knee for at least 6 months - A protocol-specified pain score for the target knee in response to Question 1 of the WOMAC pain index ("how much pain have you had [in the target knee, over the past 48 hours] when walking on a flat surface?") after washout of at least 5 half-lives of analgesic medication(s): acetaminophen, topical or oral NSAIDS, coxibs, opioids, and/or tramadol - Women of childbearing potential must use a form of contraception with a failure rate of less than 1 percent per year throughout the trial Exclusion Criteria: - Malalignment of greater than 5 degrees in the femorotibial axis of the target knee - Clinical signs of inflammation (redness) in the target knee - Intra-articular administration of corticosteroids or hyaluronic acid into either knee within 6 months before Screening - Planned knee surgery (affecting either the target or the contralateral knee) within the next two years - Concomitant conditions or treatments deemed to be incompatible with trial participation - Any contraindication to MRI according to MRI guidelines, including the inability to undergo a knee MRI exam because of inability to fit in the scanner or knee coil - Pregnancy or breastfeeding - Participation in another clinical trial within the 30 days (or 5 half-lives of the investigated compound, whichever is longer) before screening - Legal incapacity or limited legal capacity |
Country | Name | City | State |
---|---|---|---|
Argentina | Research site | Buenos Aires | |
Czechia | Research site | Brno | |
Czechia | Research site | Pardubice | |
Czechia | Research site | Prague | |
Denmark | Research site | Aalborg | |
Denmark | Research site | Ballerup | |
Denmark | Research site | Vejle | |
Estonia | Research site | Tallinn | |
Hong Kong | Research Site | Hong Kong | |
Poland | Research site | Lodz | |
Romania | Research site | Bucharest | |
United States | Research site | Baltimore | Maryland |
United States | Research site | Lakewood | Colorado |
Lead Sponsor | Collaborator |
---|---|
EMD Serono Research & Development Institute, Inc. | Nordic Bioscience A/S |
United States, Argentina, Czechia, Denmark, Estonia, Hong Kong, Poland, Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Cartilage Thickness in the Total Femorotibial Joint as Evaluated by Quantitative Magnetic Resonance Imaging (qMRI) at Year 2 | The change in cartilage thickness at 2 years was calculated based on quantitative magnetic resonance imaging (qMRI). | Baseline, Year 2 (Week 104) | |
Secondary | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | WOMAC pain subscale consists of 5 questions (Likert Scale) relating to pain. Sum of items of pain subscale ranges from 0-11. Higher scores=worse pain. Stiffness subscale consists of 2 questions relating articular function. Sum of items of stiffness subscale ranges from 0-8. Higher scores=worse function. Physical function subscale consists of 17 question relating to physical activities. Sum of items of physical function subscale ranges from 0-68. Higher scores= worse functional limitations. Each sub-scale is directly transformed into a 0-100 scale, where higher score indicates worse condition. WOMAC total score(24questions) is sum of total subscales which was directly transformed into score range from 0-100. Higher scores=worse condition. Negative value in change is indicative of improvement. | Baseline, Week 52, Week 78 and Week 104 | |
Secondary | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | The 20-meter walk test is an objective test of physical function which consists of measuring the time needed for the participant to walk 20 meters at a normal pace. A stopwatch was used for time measurement. | Baseline, Week 12, 26, 38, 52, 64, 78, 90 and 104 | |
Secondary | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | The Patient Global Assessment is based on participant's answer to the question "Considering all the ways your osteoarthritis of the knee has affected you during the last 48 Hours, select the number that best describes the impact of your knee osteoarthritis on your daily life", and can take on values between 0-10 (0=None, 10=Extreme), for summaries the values are rescaled to 0-100 by multiplication with 10. Higher scores indicated worsening of condition. A negative value in change in Patient's Global Assessment is indicative of an improvement. | Baseline, Week 12, 26, 38, 52, 64, 78, 90 and 104 | |
Secondary | Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 | Change in joint space narrowing was visualized with the "fixed flexion" knee radiograph. Determination of joint space narrowing by X-ray is considered to be a semi-quantitative method for assessment of progression of knee Osteoarthritis (OA). X-rays of both the target knee and the contralateral knee were performed. X-rays were read centrally. X-ray images were used to measure mJSW in the medial femorotibial and lateral femorotibial compartments and to determine the participant's baseline Kellgren-Lawrence grades (KLG). | Baseline, Week 52 and 104 | |
Secondary | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | The change in cartilage thickness was calculated based on quantitative magnetic resonance imaging (qMRI). | Medial and Lateral: Baseline, Week 26, 52, 78 and 104; Total: Baseline, Week 26, 52 and 78 | |
Secondary | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | The change in cartilage volume in the medial and lateral compartments as well as in the total femorotibial joint at Week 26, 52, 78 and 104 was calculated based on qMRI. | Baseline, Week 26, 52, 78 and 104 | |
Secondary | Synovial Fluid Levels of Sprifermin/FGF-18 | Levels of sprifermin/FGF-18 in synovial fluid were measured to provide a first estimate of the residence time of sprifermin in the synovial fluid. | Pre-dose at Week 0, 2 hours post-dose at Week 1 and 2 of Cycle 1, 2, 3 and 4 (each cycle is of 28 days) | |
Secondary | Serum Levels of Sprifermin/FGF-18 | Pre-dose at Week 0, 2 hours post-dose at Week 1 and 2 of Cycle 1, 2, 3 and 4 (each cycle is of 28 days) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03895489 -
Effectiveness of the Journey Total Knee Arthroplasty Versus Two Standard of Care Total Knee Arthroplasty Prostheses
|
N/A | |
Completed |
NCT03660943 -
A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain
|
Phase 3 | |
Completed |
NCT04531969 -
Comparison of Outpatient and Inpatient Spa Therapy
|
N/A | |
Completed |
NCT02848027 -
Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment
|
Phase 3 | |
Completed |
NCT05160246 -
The Instant Effect of Kinesiology Taping in Patients With Knee OA
|
N/A | |
Recruiting |
NCT06080763 -
Biomechanics and Clinical Outcomes in Responders and Non-Responders
|
||
Completed |
NCT03643588 -
The Comparison of HYAJOINT Plus and Hyalgan Hyaluronan Supplement for Knee Osteoarthritis Pain
|
N/A | |
Active, not recruiting |
NCT05100225 -
Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis
|
Phase 2 | |
Active, not recruiting |
NCT04061733 -
New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis
|
N/A | |
Completed |
NCT04051489 -
A Novel Smartphone Application for "Smart" Knee Osteoarthritis Trials
|
||
Recruiting |
NCT05546541 -
Epidemiology and Nutrition
|
||
Recruiting |
NCT05447767 -
Prediction AlgoriThm for regeneraTive Medicine Approach in knEe OA: New Decision-making Process Based on Patient pRofiliNg
|
Phase 2 | |
Not yet recruiting |
NCT04448106 -
Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis
|
Phase 2 | |
Not yet recruiting |
NCT03225911 -
Effect of a Lateral Wedge Insole and Simple Knee Sleeve in Individuals With Knee Osteoarthritis
|
N/A | |
Completed |
NCT05070871 -
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
|
N/A | |
Completed |
NCT05703087 -
Positive Cueing in Knee Arthroplasty.
|
N/A | |
Not yet recruiting |
NCT06042426 -
Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population
|
Phase 4 | |
Not yet recruiting |
NCT02854176 -
Somatosensory Stimulation in Knee Osteoarthritis
|
Phase 2 | |
Not yet recruiting |
NCT02826850 -
Saphenous Nerve Radiofrequency for Knee Osteoarthritis Trial
|
Phase 3 | |
Completed |
NCT02881775 -
Immediate Effects of rTMS on Excitability of the Quadriceps With Knee Osteoarthritis
|
N/A |