DFV890 for Knee Osteoarthritis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Novartis Investigative Site, Dallas, TXKnee OsteoarthritisDFV890 - Drug
Eligibility
50 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug for people with symptomatic knee osteoarthritis to see if it is effective, safe, and tolerable.

Eligible Conditions
  • Knee Osteoarthritis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Week 2, 4, 8 and 12

Baseline to Week 12
Change from baseline in Knee injury and Osteoarthritis Outcome Score (KOOS) pain sub-scale at week 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
Week 2
Change in KOOS pain subscale and NRS for pain from baseline to weeks 2, 4, 8 and 12
Week 19
Number of adverse events and serious adverse events
Week 12
Pharmacokinetics of DFV890: AUC last
Pharmacokinetics of DFV890: AUC0-12h
Pharmacokinetics of DFV890: Cmax
Pharmacokinetics of DFV890: Ctrough
Week 2
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

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

Trial Design

2 Treatment Groups

DFV890
1 of 2
Placebo
1 of 2

Active Control

Non-Treatment Group

108 Total Participants · 2 Treatment Groups

Primary Treatment: DFV890 · Has Placebo Group · Phase 2

DFV890
Drug
ActiveComparator Group · 1 Intervention: DFV890 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 2, 4, 8 and 12

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,735 Previous Clinical Trials
3,543,952 Total Patients Enrolled

Eligibility Criteria

Age 50 - 80 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have experienced knee pain rated between 5 and 9 on a pain scale for most days over the past 3 months.

Who else is applying?

What state do they live in?
Georgia50.0%
Texas50.0%
What site did they apply to?
Novartis Investigative Site100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria33.3%
Met criteria66.7%
Why did patients apply to this trial?
  • "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."
How many prior treatments have patients received?
150.0%
3+50.0%

How responsive is this trial?

Most responsive sites:
  1. Novartis Investigative Site: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email100.0%

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.