canakinumab for Arthrosis

Phase-Based Estimates
1
Effectiveness
2
Safety
Novartis Investigative Site, Zhuzhou, China
Arthrosis+2 More
canakinumab - Biological
Eligibility
18+
All Sexes
Eligible conditions
Arthrosis

Study Summary

This study is evaluating whether a drug called canakinumab can help people with knee osteoarthritis.

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Eligible Conditions

  • Arthrosis
  • Osteoarthritis
  • Osteoarthritis, Knee
  • Osteoarthritis of the Knee

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether canakinumab will improve 2 primary outcomes and 12 secondary outcomes in patients with Arthrosis. Measurement will happen over the course of Baseline to Day 85.

Day 15
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in daily living (ADL) subscale over time
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale over time
Change in numeric rating scale (NRS) Pain over time
Baseline to Day 197
Change in cartilage volume in the index region measured by MRI
Day 197
Change in cartilage thickness of the index region measured by MRI
Change in cartilage volume of the index region measured by MRI
Baseline to Day 85
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) Pain subscale
Change in synovitis level measured from Ktrans by Dynamic Contrast Enhanced MRI (DCE-MRI)
Day 1 and 43
LNA043 PK profile in serum (AUC)
LNA043 PK profile in serum (Cmax)
LNA043 PK profile in serum (Tmax)
Day 1
ANGPTL3 synovial fluid concentrations
Day 1
ANGPTL3 serum concentrations
Day 15
Anti-LNA043 antibodies in serum

Trial Safety

Safety Estimate

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

Trial Design

4 Treatment Groups

Placebo
canakinumab
Placebo group

This trial requires 138 total participants across 4 different treatment groups

This trial involves 4 different treatments. Canakinumab is the primary treatment being studied. Participants will be divided into 3 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.

canakinumab
Biological
canakinumab
LNA043Placebo to canakinumab + LNA043
canakinumab + LNA043canakinumab + LNA043
Placebo
Other
Placebo to canakinumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Canakinumab
FDA approved
LNA043
2015
Completed Phase 1
~40

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to day 15, 29, 43, 57, 71, 85, 197 and 365
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to day 15, 29, 43, 57, 71, 85, 197 and 365 for reporting.

Closest Location

Novartis Investigative Site - Sunrise, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You have moderate to severe OA pain (corresponding to NRS Pain ≥5 to ≤9) in the target knee for the majority of days in the last 3 months prior to Screening. show original
High sensitivity C-reactive Protein (hsCRP) ≥2 mg/L. show original
Contrast-enhanced MRI (CE-MRI) diagnosed moderate or severe knee synovitis based on an established synovititis scoring system (moderate score 9-12 or severe score ≥13)
You have KOOS pain subscale <60 for the target knee during Screening. show original
You have radiographic evidence of knee osteoarthritis (OA) in the medial tibiofemoral compartment (TFC) of the target knee. show original

Patient Q&A Section

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

Can arthrosis be cured?

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Complete healing of arthrosis occurred in only 4 of 29 patients. The prognosis of arthrosis varies widely and a specific treatment should be implemented. If, owing to comorbid conditions, a particular treatment cannot be expected, then a wait-and-see policy with close follow-up visits is advisable.

Unverified Answer

What are the signs of arthrosis?

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Arthrosis is a symptom that occurs early in the course of rheumatoid arthritis, usually in conjunction with fatigue, and is more pronounced in the early phase of disease. Arthrosis may be difficult to detect because symptoms are vague and unspecific. It is often treated with analgesics without consulting a rheumatologist. However, arthrosis often causes significant pain, joint stiffness, muscle cramping and stiffness, which can be alleviated by rheumatologists.

Unverified Answer

What causes arthrosis?

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There is no evidence that arthritis and joint pain occur more often in association with family diseases but there appears to be a strong genetic component to the joint pain and to arthritis.

Unverified Answer

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

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Annual rates of arthrosis are high and vary between states. Overall, between 3.5% and 26% of adult American women were affected by arthritis or osteoarthritis by age 70, depending on the time period and definition used. More research to define the incidence and prevalence of arthrosis and its correlation with other health indicators is needed.

Unverified Answer

What is arthrosis?

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The precise definition of arthrosis varies greatly. Thus, different methods of classification may yield different findings. Although the definitions that most arthroscopists and physicians agree with are that of the American Osteopathic Association (AOA), as of early 2020, AOA is the only association for which an official definition is available that has been evaluated by systematic review. Nevertheless, definitions of arthrosis will continue to evolve.

Unverified Answer

What are common treatments for arthrosis?

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Treatment of arthrosis is dependent on the types of injuries and the severity of the condition. This article will go into the common treatments using non operative.\n\nDental caries are among the most common diseases affecting the oral cavity and can greatly increase pain and discomfort in the mouth. Dental caries is characterized by the formation of cavities which become infected and painful. These cavities can form because of the buildup of tartar and plaque on the teeth. In order to remove the dental cavities, one can see a dental professional such as a dental hygienist or dentist or go to a dental clinic.

Unverified Answer

Does canakinumab improve quality of life for those with arthrosis?

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These data do not support canakinumab as an effective alternative to traditional therapies and support the notion that patients with poor health who have little to no pain or function may perceive a lack of improvement.

Unverified Answer

Who should consider clinical trials for arthrosis?

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Patients with symptoms related to knee osteoarthritis should consider clinical trials for treatment options. While no clinical trial has shown that clinical trials are preferable to conventional treatments, patients should consider the risks and benefits of such trials in their evaluation.

Unverified Answer

Has canakinumab proven to be more effective than a placebo?

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In this patient cohort treated with canakinumab 0.2 mg/kg and matched to placebo, canakinumab did not significantly improve clinical outcome when compared to a placebo. This non-inferiority finding does not justify canakinumab over conventional systemic therapy, and the development of canakinumab continued.

Unverified Answer

Does arthrosis run in families?

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Familial arthrosis appears to be a separate hereditary disorder with its own clinical phenotype. In the general population, the incidence in females is three to four times that of males (9.2% vs 2.2%). If arthrosis is inherited, the chance of seeing a first-degree relative who has arthrosis is 50% to 60%; and 40% of them will have bilateral involvement. The risk of arthrosis is estimated to be 8-fold higher in patients with arthropathia gyracea than in those with unilateral arthrosis. The disease probably is more common in females.

Unverified Answer

What is the primary cause of arthrosis?

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Arthrosis is a common clinical problem in patients with chronic inflammatory arthritis. Patients with arthrosis have more radiographic osteophytes, subchondral sclerosis, and joint space narrowing. In the present study cohort, only sex, age, and cartilage depth were related to the severity of arthrosis.

Unverified Answer

What is canakinumab?

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Intraarticular canakinumab was ineffective, but systemic canakinumab demonstrated measurable efficacy in patients with OA. In addition, the adverse effects of systemic canakinumab were mild and manageable.

Unverified Answer
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