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Anti-metabolites
Cladribine After Natalizumab for Multiple Sclerosis
Phase 4
Waitlist Available
Led By Olaf Stuve, MD, PhD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Minimum of 12 months of continuous natalizumab therapy (300 mg/d)
Male subjects must be willing to use a condom during dosing and for six months after the last dose, or their female partner must use another form of contraception
Must not have
Positive for HIV, or positive hepatitis C antibody test or hepatitis B surface antigen test and/or core antibody test for IgG and/or IgM
Diagnosis of PML or any suspicion of PML
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial will assess the safety and efficacy of the drug cladribine after treatment with natalizumab in patients with RRMS and active SPMS.
Who is the study for?
This trial is for adults aged 18-60 with relapsing forms of Multiple Sclerosis, including RRMS and active SPMS, who have been on natalizumab therapy for at least a year. Participants must weigh over 40 kg, not be pregnant or breastfeeding, use contraception effectively, and have no recent MS relapses. Exclusions include HIV or hepatitis infection, TB history, immunocompromised status, certain prior treatments like myelosuppressives or live vaccines recently.
What is being tested?
The study tests the safety and effects of cladribine tablets in patients previously treated with natalizumab. It aims to understand how cladribine impacts the disease's progression and immune response in those with Multiple Sclerosis after switching from another treatment.
What are the potential side effects?
Potential side effects of cladribine may include lowered blood cell counts leading to increased infection risk; allergic reactions; possible kidney issues that prevent using contrast agents like gadolinium for MRI scans; hypersensitivity reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on natalizumab (300 mg daily) for at least 12 months.
Select...
I will use a condom for six months after my last dose, or my partner will use contraception.
Select...
I weigh at least 40 kilograms.
Select...
I am between 18 and 60 years old.
Select...
I can walk without aid or rest for at least 200 meters.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am positive for HIV or hepatitis B/C.
Select...
I have been diagnosed with or suspected to have PML.
Select...
I have been treated with cladribine before.
Select...
I have been diagnosed with Clinically Isolated Syndrome.
Select...
My MS is not getting worse.
Select...
I am immunocompromised or currently on therapy that weakens my immune system.
Select...
I have had tuberculosis or currently have it.
Select...
I have been treated with drugs that lower my blood cell counts.
Select...
I cannot receive gadolinium due to a kidney condition.
Select...
I have or had cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Absolute and percent change of T cells, B cells, DC subset and NfL levels in blood.
Secondary study objectives
Annualized Relapse Rate (ARR)
Other study objectives
Magnetic Resonance imaging (MRI) outcomes
The Expanded Disability Status Scale : Neurological disability outcome
Side effects data
From 2011 Phase 3 trial • 867 Patients • NCT0064153724%
Back pain
20%
Neutropenia
12%
Lymphopenia
12%
Influenza like illness
12%
Fatigue
12%
Influenza
12%
Hyperthermia
6%
Depression
6%
Carpal tunnel syndrome
6%
Viral upper respiratory tract infection
6%
Uterine leiomyoma
6%
Upper respiratory tract infection
6%
Pain in extremity
6%
Headache
6%
Arthralgia
6%
Anxiety
6%
Hypertension
6%
Anaemia of pregnancy
6%
Eye irritation
6%
Eye pruritus
6%
Gastrooesophageal reflux disease
6%
Hypersensitivity
6%
Respiratory tract infection viral
6%
Viral infection
6%
Herpes zoster
6%
Sinusitis
6%
Infected insect bite
6%
Skin bacterial infection
6%
Contusion
6%
Joint sprain
6%
Liver function test abnormal
6%
Weight decreased
6%
Dizziness
6%
Joint swelling
6%
Pharyngolaryngeal pain
6%
Cough
6%
Restless legs syndrome
6%
Pregnancy
6%
Depressed mood
6%
Abortion threatened
6%
Iron deficiency anaemia
6%
Erythema infectiosum
6%
Tooth disorder
6%
Faecal incontinence
6%
Injection site abscess
6%
White blood cell count decreased
6%
Sensation of heaviness
6%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cladribine 3.5 mg/kg/No Treatment
Cladribine 5.25 mg/kg/No Treatment
Cladribine Low/Placebo (LLPP)
Cladribine High Dose/Placebo (HLPP)
Cladribine Low/Low Dose (LLLL)
Cladribine High/Low Dose (HLLL)
Placebo/Cladribine Low Dose (PPLL)
Placebo/No Treatment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CladribineExperimental Treatment1 Intervention
All study participants will receive treatment with cladribine 10 mg tablets at the recommended cumulative dose of 3.5 mg/kg, divided into 2 yearly treatment courses (1.75 mg/kg per treatment course). This regimen corresponds to the recommended dosage as per the USPI.
Each treatment course is divided into 2 treatment cycles:
* Administration of first treatment course (year 1 treatment):
* First cycle: Starts on Day 1 of the study
* Second cycle: Administered 23 to 27 days after the last dose of first cycle.
* Administration of second treatment course (year 2 treatment):
* First cycle: Administered at least 43 weeks after the last dose of year 1 treatment
* Second cycle: Administered 23 to 27 days after the last dose of first cycle of year 2 treatment.
The cycle dosage will be administered as 1 or 2 cladribine 10 mg tablets daily over 4 or 5 consecutive days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cladribine
2014
Completed Phase 4
~4650
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,089 Previous Clinical Trials
1,059,643 Total Patients Enrolled
15 Trials studying Multiple Sclerosis
51,654 Patients Enrolled for Multiple Sclerosis
EMD SeronoIndustry Sponsor
145 Previous Clinical Trials
27,739 Total Patients Enrolled
36 Trials studying Multiple Sclerosis
11,245 Patients Enrolled for Multiple Sclerosis
Olaf Stuve, MD, PhDPrincipal Investigator - UT Southwestern Medical Center
University of Texas Southwestern Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am positive for HIV or hepatitis B/C.I have been diagnosed with or suspected to have PML.I have been treated with cladribine before.I have been diagnosed with Clinically Isolated Syndrome.I am not pregnant or breastfeeding.My MS is not getting worse.You are allergic to cladribine.I have been diagnosed with a relapsing form of MS.My doctor thinks Natalizumab didn't work for me.Your blood platelet or white blood cell counts are too low.I have not taken steroids by mouth or injection in the last 28 days.I have been on natalizumab (300 mg daily) for at least 12 months.I understand and can follow the study's requirements.I am using effective birth control and will continue for 6 months after my last dose.I have not received a live vaccine in the last 6 weeks and do not plan to during the trial.I am immunocompromised or currently on therapy that weakens my immune system.You are allergic to gadolinium or have any reason that prevents you from getting an MRI.I haven't had any relapses in the last 28 days.I have not had cytokine, IVIG, or plasmapheresis treatments in the last 3 months.I have had tuberculosis or currently have it.Your lymphocyte count is not in the normal range according to the local hospital's lab tests.I have been treated with drugs that lower my blood cell counts.I will use a condom for six months after my last dose, or my partner will use contraception.I weigh at least 40 kilograms.I cannot receive gadolinium due to a kidney condition.I have or had cancer.I am between 18 and 60 years old.I can walk without aid or rest for at least 200 meters.
Research Study Groups:
This trial has the following groups:- Group 1: Cladribine
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.