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Regenerative Medicine
RHH646 for Knee Osteoarthritis
Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment until study completion (approximately 14 months)
Awards & highlights
Study Summary
This trial will assess a treatment to help regenerate cartilage in the knee to ease symptoms of osteoarthritis. It will last up to 62 weeks.
Who is the study for?
This trial is for adults aged 35-75 with knee osteoarthritis, meeting specific criteria like weight over 50 kg, BMI ≤35 kg/m2, and certain levels of joint space width. They must have regular knee pain relieved by analgesics. Excluded are pregnant women not using contraception, those with recent or planned surgeries on the target knee, severe malalignment in the knee, other major knee pathologies or conditions affecting MRI procedures.Check my eligibility
What is being tested?
The study tests RHH646's ability to regenerate cartilage in the knee against a placebo in participants with osteoarthritis. The treatment lasts up to one year and aims to assess both safety and effectiveness.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones for treatments like RHH646 could include injection site reactions, gastrointestinal issues (like nausea), headaches, dizziness or allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of treatment until study completion (approximately 14 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment until study completion (approximately 14 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in cartilage volume in the index region of the target knee by magnetic resonance imaging at Week 52
Number of participants with Adverse Events
Secondary outcome measures
RHH646 plasma concentrations
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RHH646Experimental Treatment1 Intervention
RHH646
Group II: PlaceboPlacebo Group1 Intervention
RHH646 placebo
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,271 Total Patients Enrolled
12 Trials studying Osteoarthritis
2,606 Patients Enrolled for Osteoarthritis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had or will have a knee scope within 6 months around my screening.My knee is severely misaligned by more than 7.5°.I weigh at least 50 kg and my BMI is 35 or less.I have other knee problems diagnosed by a doctor or through imaging.I have a known autoimmune or connective tissue disease affecting my knee.My knee joint is unstable or the ligaments are not properly fixed.I have severe hip arthritis affecting my leg function or needing treatment.I have had knee pain at least 3 days a week for the last 3 months, relieved by painkillers.I have been diagnosed with knee arthritis according to ACR criteria.I am using reliable birth control methods.I have severe osteoarthritis in at least one knee.I've had major surgery on my target knee or plan to have surgery on either knee during the study.I am between 35 and 75 years old.My knee arthritis is moderate to severe, confirmed by an X-ray.My knee pain is mainly due to the inner part of my knee wearing down more than the outer part.I have been diagnosed with knee arthritis according to ACR standards.My knee joint space width falls within the required range for my gender.I have had knee pain at least 3 days a week for the last 3 months that gets better with pain medication.
Research Study Groups:
This trial has the following groups:- Group 1: RHH646
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any age restrictions that disqualify individuals from participating in this trial?
"As stipulated in the study's enrollment criteria, participants must be between 35 and 75 years of age."
Answered by AI
Has the Food and Drug Administration accepted RHH646 for medical use?
"Our team appraised RHH646's safety with a 2, given that there is evidence of its safe usage in the Phase 2 trial, but no clinical data to suggest efficacy."
Answered by AI
Are there any vacancies for individuals within this clinical trial?
"Indeed, the clinical trial is recruiting at present. The initial posting was on May 31st 2023 and it has been revised most recently on June 8th 2023."
Answered by AI
How many individuals are registered to participate in this clinical experiment?
"Affirmative, the study is actively searching for participants. According to information found on clinicaltrials.gov, this medical trial was first posted on May 31st 2023 and has since been modified as recently as June 8th 2023. It seeks 78 individuals from a single location."
Answered by AI
Who would be an appropriate candidate for this clinical experiment?
"Patients that have been diagnosed with osteoarthritis and are between 35 and 75 years old can be considered for enrolment. Altogether, the trial seeks to recruit 78 individuals."
Answered by AI
Who else is applying?
What site did they apply to?
Novartis Investigative Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
I tried everything !!!
and I cant stop the pain !!!! My body is riddled with arthritis. My current medications are not working, only cortisone and hydraulic acid shots are somewhat helpful.
PatientReceived no prior treatments
I've tried several medicines, but there is really no cure for arthritis. I came across this study and would like to know more about it. Very interested.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Is this a paid trial? If so what is the rate of pay? How long does the study going to be? Also is the study drug a pill or injection?
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Novartis Investigative Site: < 48 hours
Average response time
- < 2 Days
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