CLINICAL TRIAL

XT-150 for Arthrosis

Recruiting · 18+ · All Sexes · Napa, CA

Safety and Efficacy of XT-150 for Facet Joint Osteoarthritis Pain

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About the trial for Arthrosis

Eligible Conditions
Osteoarthritis · Back Pain · Inflammation · Facet Joint Pain · Arthralgia

Treatment Groups

This trial involves 3 different treatments. XT-150 is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
XT-150
BIOLOGICAL
Experimental Group 2
XT-150
BIOLOGICAL
Control Group 3
Placebo
BIOLOGICAL

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
XT-150
2018
Completed Phase 1
~80

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
There is evidence of arthritis in the facet joints of the lower back, as seen on an MRI or CT scan show original
The investigator has determined that the person has an acceptable general medical condition. show original
The individual has pain that is located in the middle of their back, as opposed to down their spine show original
The individual has a symptomatic disease caused by osteoarthritis, which has been established by imaging of the facet joint and is defined as a worst pain of at least 50 at any time during the preceding week, as measured on the Visual Analog Scale. show original
The person experiences pain that does not improve with previous therapies and the pain lasts for 3 months or more. show original
Low back pain symptoms tend to worsen when you move your back or when you do certain activities. show original
A person who is either male or female, who is between 18 and 90 years of age, inclusive. show original
I had a positive diagnostic facet pain block with lidocaine; admission if the subject gains 50% relief of pain within 30 minutes of the test injection. show original
Patients should not have any local or intra-articular infection, tumor, or other causes of localized back pain when evaluated with imaging, for example, spondylolysis/pars defect, and adjacent vertebral body compression fracture. show original
Patients were required to have a stable analgesic regimen for 4 weeks before enrolling in the study. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Day 180
Screening: ~3 weeks
Treatment: Varies
Reporting: Day 180
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day 180.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether XT-150 will improve 1 primary outcome, 1 secondary outcome, and 3 other outcomes in patients with Arthrosis. Measurement will happen over the course of Day 0 to day 180.

Incidence of Treatment-Emergent Adverse Events after an intra-articular dose of study drug (XT-150 or Placebo)
DAY 0 TO DAY 180
Adverse events will be collected and recorded in the eCRF throughout the duration of the trial.
DAY 0 TO DAY 180
Change from baseline in low back pain intensity
DAY 180
Pain intensity will be on a 0-100 Visual Analog Scale of Pain Intensity (VAS).
DAY 180
Change from baseline on self-reported physical activity
DAY 180
Self reported physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ short form) High-Moderate-Low categories
DAY 180
Change from baseline in back disability
DAY 180
Back disability assessed using the Oswestry Disability Questionnaire. 0%-100 disability scale
DAY 180
Change from baseline on Quality of Life
DAY 180
Quality of Life assessed using the Short Form Health Survey (SF12)physical and mental components. Scores range from 0-100, with higher scores indicating better physical and mental health.
DAY 180

Patient Q & A Section

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

What is inflammation?

Inflammation is the term that is most commonly used to denote the reaction of the body to foreign or harmful constituents. Inflammation results in localized and systemic responses in the body, which can range from superficial or local symptoms such as pain or swelling, to extreme responses such as fever, and a generalized response can lead to organ dysfunction and death.\n

Anonymous Patient Answer

Can inflammation be cured?

In this pilot study of patients with rheumatoid arthritis, no significant improvement was seen after 24 weeks of therapy with an oral anti-tumour necrosis factor-alpha agent compared with placebo. However, a trend towards improvement was observed in a significant proportion of anti-tumour necrosis factor-alpha-positive patients. Since RA is a chronic inflammatory disease that has an uncertain response to anti-tumour necrosis factor-alpha agents, further studies with a longer followup of these patients are required to determine whether long term remission or clinical improvement is actually achievable.

Anonymous Patient Answer

How many people get inflammation a year in the United States?

Nearly 10% of the U.S. population report having had an inflammatory symptom/condition in the preceding 12 months. The proportion who report having had such an event is considerably higher for individuals with more severe, and often more disabling disorders.

Anonymous Patient Answer

What are the latest developments in xt-150 for therapeutic use?

xt-150 for therapeutic use is still in its early clinical phase; however, recent advances in antibody engineering have provided many promising new options for the development of specific antibody-drug conjugates targeting tumor tissue of diverse targets.

Anonymous Patient Answer

What are the signs of inflammation?

Many conditions in inflammatory bowel disease are hard to diagnose and consequently there is no evidence to support the use of this term. The absence of conclusive evidence does not exclude the possibility that there might be systemic signs of inflammation associated with IBD.

Anonymous Patient Answer

What causes inflammation?

The inflammatory response plays an important role in the body, and there has been mounting evidence that it is one of the causes of many of the chronic diseases of our society. The inflammatory process is tightly regulated to ensure the body's ability to recover from acute infection without tissue injury. Dysregulation can lead to more rapid pathology but is necessary for the proper response to acute infection. Understanding this process gives us the opportunity to block the inflammatory response and prevent disease.

Anonymous Patient Answer

What are common treatments for inflammation?

Treatments for many inflammatory disorders share a common molecular pathway: activation of NF-kappaB transcription factor. Treatments are diverse but many are aimed at blocking the innate response or inhibiting NF-κB activation, although these are not universally effective or safe. Common treatments for arthritis, ankylosing spondylitis, allergies, multiple sclerosis, interstitial cystitis, and psoriasis share numerous similarities in their mechanisms and treatment.

Anonymous Patient Answer

Have there been other clinical trials involving xt-150?

The data suggest that XL110 is associated with very low rates of adverse events in patients with moderate to severe UC. In this small cohort, no significant differences were seen in the incidence of any adverse events between XL110-treated patients and those receiving placebo.

Anonymous Patient Answer

What is the primary cause of inflammation?

The inflammatory response is generally due to an aberrant immune response to a nonpathogenic stimulus such as bacterial, fungal, or viral infection in the intestine. Bacteria, viruses, and parasitic or protozoan infections have been hypothesized as the initiating factor and the innate defense against these pathogens is responsible for an elevated I/M and the development of inflammation.

Anonymous Patient Answer

Does xt-150 improve quality of life for those with inflammation?

The data suggest that it is worthwhile to investigate xt-150 as an intervention for persons with chronic inflammatory diseases (both rheumatoid arthritis and scleroderma). In particular, patients with comorbidity should be included in the trial to minimise placebo responses.

Anonymous Patient Answer

Have there been any new discoveries for treating inflammation?

Although we continue to search for the ideal therapies in the world's worst epidemic for common diseases, it is time we looked at approaches that can treat both the cause and the disease itself. The use of anti-inflammatory drugs as well as the control of the inflammatory response are essential elements to halting and even reversing diseases like rheumatoid arthritis. Drugs such as celecoxib, a nonsteroidal anti-inflammatory drug (NSAID) that reduces the production of inflammatory mediators, may provide valuable insights into novel anti-inflammatory strategies.

Anonymous Patient Answer

How serious can inflammation be?

The high rate of depression, insomnia, fatigue, memory change, and fatigue were all found in this study. It was also found that this is correlated with the severity and severity of these symptoms. The correlation between the severity of depression and fatigue is seen over a short time frame. So the symptoms of the disease seem to be worsening, but at a relatively slow rate.

Anonymous Patient Answer
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