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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2, 4, 8 and 12
Awards & highlights
Study Summary
This trial is testing a new drug for people with symptomatic knee osteoarthritis to see if it is effective, safe, and tolerable.
Who is the study for?
Adults aged 50-80 with knee osteoarthritis, pain in the target knee for most days over the past 3 months, and certain levels of inflammation as shown by blood tests and MRI. They must weigh at least 50 kg with a BMI of 18-35 kg/m2. Excluded are those with other arthritis types, severe malalignment in their knee, certain blood disorders or infections, or using prohibited medications.Check my eligibility
What is being tested?
The trial is testing DFV890's effectiveness compared to a placebo in reducing symptoms of knee osteoarthritis. Participants will be randomly assigned to receive either DFV890 or a placebo without knowing which one they're getting (double-blinded). The study spans up to 21 weeks including screening, treatment, and follow-up periods.See study design
What are the potential side effects?
While specific side effects for DFV890 aren't listed here, common side effects for treatments like this may include gastrointestinal issues such as nausea or diarrhea; allergic reactions; headaches; dizziness; and potential liver enzyme elevations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 2, 4, 8 and 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 2, 4, 8 and 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in Knee injury and Osteoarthritis Outcome Score (KOOS) pain sub-scale at week 12
Secondary outcome measures
Change from baseline in KOOS sub-scales (other symptoms, function in daily living, function in sport and recreation, knee-related quality of life) at weeks 2, 4, 8 and 12
Change from baseline in serum high sensitivity C-reactive protein level and absolute neutrophil counts at week 2,4,8 and 12
Change from baseline in synovitis activity level measured from Ktrans by DCE-MRI at week 12
+6 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: DFV890Active Control1 Intervention
DFV890
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for knee osteoarthritis primarily aim to reduce inflammation and alleviate pain. Nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit cyclooxygenase enzymes (COX-1 and COX-2), reducing the production of pro-inflammatory prostaglandins, which helps decrease pain and swelling.
Corticosteroids, administered intra-articularly, suppress multiple inflammatory pathways, providing short-term pain relief. Newer investigational treatments, such as anti-nerve growth factor (anti-NGF) antibodies, block NGF to reduce pain signaling, while matrix metalloproteinase inhibitors aim to prevent cartilage degradation by inhibiting enzymes that break down extracellular matrix components.
These mechanisms are crucial for knee OA patients as they target the underlying inflammation and pain, improving joint function and quality of life.
Recommendations of the French Society of Rheumatology on pharmacological treatment of knee osteoarthritis.A systematic review of randomized controlled trials of pharmacological therapy in osteoarthritis of the knee, with an emphasis on trial methodology.
Recommendations of the French Society of Rheumatology on pharmacological treatment of knee osteoarthritis.A systematic review of randomized controlled trials of pharmacological therapy in osteoarthritis of the knee, with an emphasis on trial methodology.
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,868 Previous Clinical Trials
4,199,768 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My knee pain score is 60 or less.My knee pain score is 60 or less.I have had knee pain rated between 5 to 9 for most days in the last 3 months.My knee X-ray shows moderate to severe arthritis.I have had moderate to severe knee pain most days in the last 3 months.I have had knee pain most days in the last 3 months, rated between 5 to 9.I do not have active infections like HIV or chronic hepatitis B or C.I have not taken any prohibited medications recently.I have an autoimmune or joint disease, or an infection in my knee.I am between 50 and 80 years old.My knee MRI shows active inflammation in the joint.My knee is severely misaligned by more than 7.5 degrees.I weigh at least 50 kg and my BMI is between 18 and 35.My knee MRI shows I have moderate to severe inflammation.I weigh at least 50 kg and my BMI is between 18 and 35.My knee X-ray shows moderate to severe arthritis.I am between 50 and 80 years old.I'm sorry, but "Key" is not a screening criterion. It's unclear what you are referring to. Please provide more context or information.My knee X-ray shows moderate to severe arthritis.
Research Study Groups:
This trial has the following groups:- Group 1: DFV890
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Knee Osteoarthritis Patient Testimony for trial: Trial Name: NCT04886258 — Phase 2
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