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DFV890 for Knee Osteoarthritis

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
KOOS pain sub-scale score must be <= 60 in index knee at screening and baseline
Radiographic disease: K&L grade 2 or 3 knee osteoarthritis in the target knee confirmed by X-ray at screening
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My knee pain score is 60 or less.
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My knee X-ray shows moderate to severe arthritis.
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I am between 50 and 80 years old.
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I weigh at least 50 kg and my BMI is between 18 and 35.
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My knee MRI shows active inflammation in the joint.

Timeline

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

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 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: DFV890Active Control1 Intervention
DFV890
Group II: PlaceboPlacebo Group1 Intervention
Placebo

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,852 Previous Clinical Trials
4,197,637 Total Patients Enrolled

Media Library

DFV890 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04886258 — Phase 2
Knee Osteoarthritis Research Study Groups: DFV890, Placebo
Knee Osteoarthritis Clinical Trial 2023: DFV890 Highlights & Side Effects. Trial Name: NCT04886258 — Phase 2
DFV890 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04886258 — Phase 2
Knee Osteoarthritis Patient Testimony for trial: Trial Name: NCT04886258 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I become part of this medical research?

"This clinical trial is accepting candidates between the ages of 50 and 80, who are suffering from osteoarthritis in their knee. Around 108 individuals will be selected for participation."

Answered by AI

To what extent has recruitment expanded for this trial?

"Affirmative, clinicaltrials.gov confirms that recruitment is ongoing for this trial which was first listed on September 20th 2021. The latest update to the listing occurred November 21st 2022 and the team needs to enlist 108 patients from 8 different medical facilities."

Answered by AI

Is this experiment accepting new participants at the moment?

"Affirmative, clinicaltrials.gov corroborates that this research trial is actively seeking patients. Originally posted on September 20th 2021, it was recently updated on November 21st 2022 and requires 108 participants from 8 distinct sites."

Answered by AI

Has DFV890 received clearance by the Food and Drug Administration?

"While there is preliminary data suggesting the safety of DFV890, efficacy has yet to be tested. Consequently, our team at Power rated it a 2 on a scale from 1-3."

Answered by AI

What is the number of healthcare institutions conducting this experiment?

"At present, this medical trial is being conducted in 8 different sites. These locations span from Plantation to Miami Lakes and Chicago with many other places in between. If you are looking to participate, it is best to choose the nearest centre so as not to burden yourself with excessive travel."

Answered by AI

Is this trial available for those over the age of 40?

"This experiment is only open to individuals between 50 and 80 years of age. There are 38 trials catering to youths below 18, while 656 studies cater to the elderly population above 65."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Georgia
Texas
What site did they apply to?
Novartis Investigative Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+

Why did patients apply to this trial?

I have severe knee arthritis and do not want surgery. Knee pain and synovisc seems to be less effective than it had been. I want to continue running and doing triathlons.
PatientReceived no prior treatments
I have arthritis and extensive pain due to no remaining meniscus in my right knee. I have had hyaluronic gel injections for temporary relief but they are wearing off. I do not want a knee replacement yet, and I have two children under the age of 6 that I would like to remain active with.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Novartis Investigative Site: < 48 hours
Average response time
  • < 2 Days
~28 spots leftby Mar 2025