What side effects are associated with this type of intervention?

Common treatments for knee osteoarthritis, such as NSAIDs (e.g., naproxen, ibuprofen, celecoxib), can cause gastrointestinal issues like ulcers and bleeding, cardiovascular risks, and kidney problems. Glucocorticoids, used for their anti-inflammatory effects, may lead to side effects such as weight gain, osteoporosis, and increased blood sugar levels. Other treatments like duloxetine can cause nausea, dry mouth, and fatigue. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for knee osteoarthritis, primarily focusing on pain relief and anti-inflammatory effects. Nonsteroidal anti-inflammatory drugs (NSAIDs) such as naproxen, ibuprofen, and celecoxib are commonly used and have been shown to provide symptomatic relief. Duloxetine, an antidepressant, has also been approved for chronic osteoarthritis pain management. Investigational treatments like bisphosphonates (e.g., zoledronic acid) and gene therapy (e.g., TissueGene-C) have shown promise in clinical trials but are not yet widely approved. These treatments aim to reduce pain and inflammation, similar to the investigational drug DFV890.

What other types of research exist?

Promising, novel alternatives to DFV890 for knee osteoarthritis treatment include AZD3582, ONO-4474, sprifermin, and diclofenac etalhyaluronate (DF-HA). These treatments have shown efficacy, safety, and tolerability in clinical studies.

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DFV890 for Knee Osteoarthritis

Verified Trial

Phase 2

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are you between the ages of 50 and 80?

Do you have mild to moderate knee pain due to osteoarthritis?

Must not have

Have you had a partial or total knee replacement?

Have you had any other knee surgery on either knee within the past 6 months?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 2, 4, 8 and 12

Summary

This trial is testing a new medication called DFV890 to see if it can help people with painful knee osteoarthritis. The study will check if the medication can reduce knee pain and improve how well the knee works. Participants will be monitored for safety and how well they tolerate the medication.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2, 4, 8 and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in Knee injury and Osteoarthritis Outcome Score (KOOS) pain sub-scale at week 12

Secondary study objectives

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 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: DFV890Active Control1 Intervention

DFV890

Group II: PlaceboPlacebo Group1 Intervention

Placebo

0 / 6Eligibility criteria met

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.