CNTX-6970 for Arthrosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of California- Davis, Sacramento, CA
Arthrosis+2 More
CNTX-6970 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug can reduce pain in people with osteoarthritis of the knee.

See full description

Eligible Conditions

  • Arthrosis
  • Osteoarthritis of the Knee

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether CNTX-6970 will improve 2 primary outcomes and 12 secondary outcomes in patients with Arthrosis. Measurement will happen over the course of 1 Week.

1 Week
MCP-1/CCR-2
Synovial fluid levels of cytokines and chemokines
24 Weeks
Actigraphy
Bedside Quantitative Sensory Testing (QST)
Ecological Momentary Assessment (EMA)
Hospital Anxiety and Depression Scale (HADS)
Numeric Rating Scale (NRS)
PROMIS Sleep Disturbance Scale - 6A
Patient Global Impression of Change (PGIC)
Serum levels of cytokines and chemokines
Staircase-evoked pain assessment
Treatment emergent adverse events (TEAEs)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-C)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

4 Treatment Groups

Active comparator
1 of 4
300mg BID
1 of 4
100mg BID
1 of 4
Placebo
1 of 4
Active Control
Experimental Treatment
Non-Treatment Group

This trial requires 150 total participants across 4 different treatment groups

This trial involves 4 different treatments. CNTX-6970 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.

300mg BID
Drug
The higher dose (i.e., 300mg BID) demonstrated good tolerability and safety, as well as over 90% inhibition of the binding of monocyte chemoattractant protein-1 to its CCR-2 receptor. Moreover, this dose produced nearly 90% binding inhibition at the CCR-5 receptor as well.
100mg BID
Drug
The lower dose proposed in this Phase 2 trial (100mg BID), which provides 1/3 of the exposure to CNTX-6970 relative to the higher dose, will generate informative data on the dose-related effects of the compound.
Placebo
Drug
Placebo
Active comparator
Drug
The active comparator in the trial is Celecoxib 100mg BID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Celecoxib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24 weeks for reporting.

Closest Location

University of California- Davis - Sacramento, CA

Eligibility Criteria

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.

Mark “yes” if the following statements are true for you:
I can understand the nature of the study and the protocol requirements, and I am willing to comply with the study drug administration requirements and discontinue any prohibited concomitant medications. show original
Both knees were radiographed using a posterior-anterior, fixed-flexion view during the Screening visit show original
There was no significant difference in improvement between those who received adequate and inadequate responses to treatment show original
The subject has moderate to severe pain in the Index knee, which is associated with OA and has been stable for a minimum of 6 months prior to Screening, in the opinion of the investigator. show original
The index knee has been assessed and found to meet the American College of Rheumatology (ACR) diagnostic criteria for osteoarthritis. show original
managements Unacceptable adverse events can occur during management. show original
People in the age group of 45 to 80 years old. show original
willing to use a mobile phone during the study period show original
Agrees to have any information obtained from the study used for research purposes show original
The subject can communicate with the site personnel, complete subject-reported outcome measures, and be rated on assessment scales. show original

Patient Q&A Section

How many people get osteoarthritis, knee a year in the United States?

"Results from a recent paper illustrates the extent to which data are readily available about arthritis, and offers specific insight into the demographics, management and management outcome of this disease in the US." - Anonymous Online Contributor

Unverified Answer

What causes osteoarthritis, knee?

"Factors that are associated with the development of [osteoarthritis](https://www.withpower.com/clinical-trials/osteoarthritis), knee, in the elderly are gender, age and ethnicity as well as preexisting arthritis or other joint problems. While some predisposing factors can be identified, the precise causes of osteoarthritis are not yet fully understood, but are thought to result from several possible pathways." - Anonymous Online Contributor

Unverified Answer

Can osteoarthritis, knee be cured?

"Patients suffering from knee osteoarthritis of both knee joints may benefit from treatment by a multifaceted and complex treatment strategy with conservative treatment strategies, especially by physiotherapy, non-steroidal anti-inflammatory drugs, and analgesics. Patients with high-intensity pain may benefit from an injection therapy (especially a mixture of glucocorticoids with local anaesthetic)." - Anonymous Online Contributor

Unverified Answer

What are common treatments for osteoarthritis, knee?

"One of the most important and well-researched aspects for the treatment of knee OA is physiotherapy. In order to increase the effects of these therapies, the number of physiotherapists present in the clinic is essential. It is also important for clinical assessments to be done and repeated at least once per week during the treatment. Treatment approaches like intra-articular injections, local hyperbaric oxygen therapy, or ultrasound are other potential approaches in knee OA. Surgery is another potential treatment option for knee OA. However, it is only implemented as the last resort." - Anonymous Online Contributor

Unverified Answer

What is osteoarthritis, knee?

"According to the American Academy of Osteopathic Family Physicians, the diagnosis of osteoarthritis, knee, is a condition that causes pain and stiffness, swelling, weakness, and possibly discolouration to one or more joint(s). These symptoms can cause significant functional impairment and are more common in older individuals." - Anonymous Online Contributor

Unverified Answer

What are the signs of osteoarthritis, knee?

"Many people with [knee [osteoarthritis](https://www.withpower.com/clinical-trials/osteoarthritis)](https://www.withpower.com/clinical-trials/knee-osteoarthritis) do not have symptoms and may not report symptoms to a healthcare provider until the joint becomes very painful and/or they experience limitations in their ability to walk or do other activities of daily living. As a result, diagnosis of knee osteoarthritis is often delayed, and treatment options for knee arthritis may be delayed (if treatment is received at all). The primary physical symptom of knee arthritis that correlates with worse functional outcomes (i.e., decreased quality of life) is knee pain (also known as osteoarthritis-related pain or joint stiffness). These symptoms are also associated with pain on the lesser extremities, although functional limitation is not as strong." - Anonymous Online Contributor

Unverified Answer

How does cntx-6970 work?

"In OA, the chondrocyte-expressed CCNT7 gene was expressed. Knockdown of endogenous CCNT7 expression in OA chondrocytes reduced in vitro proliferation rates and accelerated chondrocyte phenotype maturation. Results from a recent clinical trial suggest the potential role of CCNT7 in the pathogenesis of OA and the potential for CCNT7 inhibition as a therapeutic strategy for the OA process." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving cntx-6970?

"In a recent study, findings provides evidence of the clinical efficacy of p4565 in this patient population. Given the significant and sustained anti-oxidant and anti-cytotoxic properties, p4565 has the potential for future clinical application in managing ROS-mediated tissue damage, a common feature of many arthritis-related disorders." - Anonymous Online Contributor

Unverified Answer

Does cntx-6970 improve quality of life for those with osteoarthritis, knee?

"Findings from a recent study do not indicate Cntx-6970 is advantageous compared to placebo in the treatment of OA, although it still results in improvements in some domains of knee pain, function, and patient satisfaction. Further research on this medication to further understand the contribution it may make to improving outcomes in OA patients is warranted." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of osteoarthritis, knee?

"[When a patient has osteoarthritis, more than one factor generally is involved]: [1] pain and/or stiffness, which often is multifactorial; [2] joint space narrowing, which is the primary symptom observed; [3] alteration of the joint biomechanics; [4] deterioration of the articular cartilage; and [5] changes in surrounding cartilage and osteophyte formation. (http://www.hicc.edu/pdf/Osteoarthritis.pdf." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of cntx-6970?

"Common side effects (greater than 1% incidence) include pain, erythema, skin redness, and hypertrichosis. The most commonly reported side effect of celecoxib in patients with osteoarthritis of the knee was upper respiratory tract irritation (5%). This is similar to other NSAIDs (e.g., diclofenac). Side effects are most commonly mild, but often appear sooner among women than in men or among users of extended-release products than with immediate-release products. Women and smokers are at increased risk for more severe or frequent side effects." - Anonymous Online Contributor

Unverified Answer

How serious can osteoarthritis, knee be?

"There is ample evidence that OA is a common problem and that it leads to low scores on the self-administered health survey, EQ-5D and VAS scales. Thus a direct comparison of the effect of interventions for [osteoarthritis](https://www.withpower.com/clinical-trials/osteoarthritis) on the above measures of health is very straightforward. However the results have to be interpreted in the light of the wide variations that exist in the extent to which different clinical trials and populations with different levels of disease severity included in the comparisons." - 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.
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