Your session is about to expire
← Back to Search
Immunomodulator
Mavenclad® for Multiple Sclerosis
Phase 4
Waitlist Available
Research Sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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 year 3 to 4 after the initial dose of mavenclad® tablets in parent study
Awards & highlights
Study Summary
This trial is evaluating the long-term effectiveness of Mavenclad in participants with relapsing multiple sclerosis who were previously in another trial.
Who is the study for?
This trial is for people who have highly-active relapsing multiple sclerosis (RMS) and were part of the earlier MAGNIFY MS study. They must have MRI data from that study, an EDSS score, a record of relapses, and have taken at least one dose of Mavenclad® during the initial trial.Check my eligibility
What is being tested?
The focus is on understanding how effective and safe Mavenclad® tablets are over a long period for treating RMS. Participants are those who previously joined the MAGNIFY MS trial and will continue to be observed for disease activity and any safety issues.See study design
What are the potential side effects?
While not specified here, common side effects of Mavenclad® may include low white blood cell counts which can increase infection risk, liver problems, allergic reactions, or potential harm to unborn babies if used during pregnancy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 3 to 4 after the initial dose of mavenclad® tablets in parent study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 3 to 4 after the initial dose of mavenclad® tablets in parent study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants with No Evidence of Disease Activity (Three Parameter [NEDA-3]) During Year 3 to 4
Secondary outcome measures
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Percentage of Participants Remaining Three Parameter No Evidence of Disease Activity (NEDA-3) During Year 3 or 4 among those with NEDA-3 During Year 1 or 2
Percentage of Participants with No Evidence of Disease Activity (Three Parameter [NEDA-3]) After the Onset of Action of Mavenclad® Treatment During the Parent Study until the End of Year 3 and 4
+15 moreSide effects data
From 2022 Phase 4 trial • 270 Patients • NCT0336403632%
Headache
21%
Nasopharyngitis
12%
Urinary tract infection
11%
Fatigue
11%
Back pain
11%
Nausea
10%
Upper respiratory tract infection
10%
Lymphopenia
10%
Diarrhoea
8%
Pain in extrimity
8%
Alopecia
7%
Dizziness
7%
Arthralgia
7%
Oral herpes
6%
Paraesthesia
6%
Anxiety
6%
Insomnia
6%
Muscle Spasm
5%
Neck Pain
1%
Cerebrovascular accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
Experimental: Mavenclad®
Trial Design
1Treatment groups
Experimental Treatment
Group I: Mavenclad®Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cladribine
FDA approved
Find a Location
Who is running the clinical trial?
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyLead Sponsor
51 Previous Clinical Trials
6,642 Total Patients Enrolled
7 Trials studying Multiple Sclerosis
3,344 Patients Enrolled for Multiple Sclerosis
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
288 Previous Clinical Trials
68,756 Total Patients Enrolled
42 Trials studying Multiple Sclerosis
24,840 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- We need to have MRI data from your Month 18 or Month 24 visit in the previous study.You have a certain level of disability and experienced a relapse in the 24th month of the previous study.People who took at least one dose of cladribine tablets during the MAGNIFY MS trial.
Research Study Groups:
This trial has the following groups:- Group 1: Mavenclad®
Awards:
This trial has 5 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
To what extent does Mavenclad® present a hazard for patients?
"Due to it being a Phase 4 trial, Mavenclad® has been granted an overall safety rating of 3."
Answered by AI
Are there any additional investigations concerning the efficacy of Mavenclad®?
"At present, 34 clinical trials have been launched to study Mavenclad® with 7 of them having reached Phase 3. Houston is one major centre running these tests but there are 359 other locations that offer the same opportunity."
Answered by AI
Are there openings for participants in this scientific experiment?
"Per the details on clinicaltrials.gov, this research initiative is not currently searching for participants, having initially been posted March 10th 2021 and last updated November 23rd 2022. Nevertheless there exist 583 other trials actively recruiting subjects at present."
Answered by AI
What medicinal purposes is Mavenclad® indicated for?
"Mavenclad® can provide relief to those suffering from ctage1 protein, human hairy cell leukemia, and multiple sclerosis."
Answered by AI
What is the current enrollment capacity of this research project?
"At the moment, this research project is not enrolling patients. This medical trial was initially posted on March 10th 2021 and has been recently revised November 23rd 2022. For those seeking alternative trials, there are 549 studies for multiple sclerosis and 34 for Mavenclad® actively enrolling participants."
Answered by AI
Are there any North American hospitals conducting this research project?
"Presently, there are 4 sites offering this trial - Montreal, Edmonton, London and other nearby locations. To reduce the amount of travel required to participate in this study, it is best to identify a centre near you."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Sahlgrenska Universitetssjukhus
Queen Elizabeth Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger