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Clinical Trial NCT07481474 for Knee Osteoarthritis (Knee OA) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Pilot and Feasibility Study of Intra-articular Anti-CD14 for the Treatment of Knee Osteoarthritis Phase 1 30 Randomized Veterans Short-Term High Unmet Need

Not yet recruiting
Clinical Trial NCT07481474 is designed to study Treatment for Knee Osteoarthritis (Knee OA). This Phase 1 interventional study is not yet recruiting. Enrollment is planned to begin on 1 June 2026 until the study accrues 30 participants. Led by VA Office of Research and Development, this study is expected to complete by 1 January 2028. The latest data from ClinicalTrials.gov was last updated on 18 March 2026.
Brief Summary
Knee osteoarthritis (KOA) is a leading cause of chronic pain and disability among Veterans, which contributes significantly to reduced mobility, impaired quality of life, and increased health care utilization. First-line therapies, including non-steroidal anti-inflammatory drugs, physical therapy, and intra-articular corticosteroids, provide modest and short-term relief, while being associated with other side effects...Show More
Detailed Description
In recent years, pain in osteoarthritis has been tied to inflammation in the joint. For example, Philpott et al. found that, among 258 patients with KOA, moderate to severe synovitis on ultrasound was associated with a 2- to 4-fold increase in the risk of constant and intermittent pain. A prior study in 535 patients from the Multicenter Osteoarthritis Study (MOST) cohort found that the presence of synovitis on contra...Show More
Official Title

Pilot and Feasibility Study of Intra-articular Anti-CD14 for the Treatment of Knee Osteoarthritis

Conditions
Knee Osteoarthritis (Knee OA)
Other Study IDs
  • RRDC-003-23S-T1
  • 1915270 (Other Identifier) (Corporal Michael J Crescenz VA Medical Center)
NCT ID Number
NCT07481474
Start Date (Actual)
2026-06-01
Last Update Posted
2026-03-18
Completion Date (Estimated)
2028-01-01
Enrollment (Estimated)
30
Study Type
Interventional
PHASE
Phase 1
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalAtibuclimab 100 mg
Atibuclimab (intra-articular)
Intra-articular injection of Atibuclimab
ExperimentalAtibuclimab 40 mg
Atibuclimab (intra-articular)
Intra-articular injection of Atibuclimab
Placebo ComparatorPlacebo (saline only)
saline placebo
2 mL
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Rates of screening and randomization
The number of randomized participants relative to the number screened. The screening protocol will be considered feasible if 1/2 of screened patients are eligible to be randomized.
2 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Rates of study completion
Rates of completion of study procedures. The design will be considered to be feasible if 90% complete 4-month follow-up from randomization.
2 years
Rates of serious adverse events
The study will quantify emergency room visits, hospitalizations, and life-threatening events and determine relatedness. Rates will be quantified over 4 months of follow-up and evaluated descriptively by group.
4 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
50 Years
Eligible Sexes
All
  • ACR Classification Criteria for Knee Osteoarthritis
  • Pain >=5 on Visual Analogue Scale
  • Kelgren-Lawrence Grade >1
  • Joint Effusion on Exam
  • Able to provide informed consent

  • Serious or hospitalized infection in last 1 year
  • Poorly controlled crystal arthritis in last 6 months
  • Pain Pressure Threshold (PPT) testing <=3
  • History of diagnosed fibromyalgia
  • Receipt of corticosteroid in affected knee within 3 months
  • Receipt of visco-supplementation or other intra-articular therapy (other than corticosteroid) within 6 months
  • Ongoing participation in another interventional study
  • Inability to ambulate without assistive device
  • Pregnancy or Lactation
  • History of knee arthroplasty in either knee
  • Symptomatic heart failure
  • Glomerular filtration rate <45
  • Class III obesity (BMI>40 kg/m2)
  • Recent active malignancy (chemotherapy, radiation, or surgery within 3 months)
  • Poorly controlled diabetes (A1c>8%)
  • Rheumatoid Arthritis
  • Psoriatic Arthritis
VA Office of Research and Development logoVA Office of Research and Development
Study Central Contact
Contact: Joshua F Baker, MD, MSCE, 215-823-5800, [email protected]
Contact: Criswell LM Lavery, MPH, 215-823-4630
1 Study Locations in 1 Countries

Pennsylvania

Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, Pennsylvania, 19104, United States
Criswell LM Lavery, MPH, Contact, 215-823-4630, [email protected]