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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 below
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I have been on natalizumab (300 mg daily) for at least 12 months.
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I will use a condom for six months after my last dose, or my partner will use contraception.
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I weigh at least 40 kilograms.
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I am between 18 and 60 years old.
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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:
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I am positive for HIV or hepatitis B/C.
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I have been diagnosed with or suspected to have PML.
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I have been treated with cladribine before.
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I have been diagnosed with Clinically Isolated Syndrome.
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My MS is not getting worse.
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I am immunocompromised or currently on therapy that weakens my immune system.
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I have had tuberculosis or currently have it.
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I have been treated with drugs that lower my blood cell counts.
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I cannot receive gadolinium due to a kidney condition.
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I have or had cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

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 • NCT00641537
24%
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
~4410

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,081 Previous Clinical Trials
1,056,293 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

Cladribine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04178005 — Phase 4
Multiple Sclerosis Research Study Groups: Cladribine
Multiple Sclerosis Clinical Trial 2023: Cladribine Highlights & Side Effects. Trial Name: NCT04178005 — Phase 4
Cladribine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04178005 — Phase 4
~7 spots leftby Nov 2025
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