Cladribine Tablets: Collaborative Study to Evaluate Impact On Central Nervous System Biomarkers in Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 1 April 2024
• Main ID: NCT03963375
• Date of registration: 23/05/2019
• Prospective Registration: Yes
• Primary sponsor: Washington University School of Medicine
• Public title: Cladribine Tablets: Collaborative Study to Evaluate Impact On Central Nervous System Biomarkers in Multiple Sclerosis CLOCK-MS
• Scientific title: Cladribine Tablets: Collaborative Study to Evaluate the Impact On Central Nervous System Biomarkers in Multiple Sclerosis
• Date of first enrolment: October 28, 2019
• Target sample size: 47
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03963375
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Gregory Wu
• Affiliation: Washington University School of Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Have a relapsing form of multiple sclerosis (RMS; to include RRMS or active secondary
progressive MS)

2. Are willing and able to receive at least 2 lumbar punctures

3. Have an EDSS of 0 to = 5.5 during the screening period

4. Had at least 1 relapse or 1 gadolinium-enhancing or 1 new or enlarged T2 lesion in the
last 12 months

5. Have absolute lymphocyte count (ALC) within normal range of the local laboratory or
assessed as normal by the investigator within the 3 week screening period and meet all
other eligibility criteria for cladribine tablet treatment

6. Capable of giving signed informed consent

Exclusion Criteria:

1. Have any contraindication for lumbar puncture

2. Have current malignancy

3. Are infected with human immunodeficiency virus (HIV)

4. Have active chronic infections (e.g. hepatitis or tuberculosis)

5. Have signs or symptoms suggestive of progressive multifocal leukoencephalopathy (PML)
in MRI

6. Have history of hypersensitivity to cladribine or any of the excipients listed in the
cladribine tablets US Prescribing Information

7. Allergy or hypersensitivity to gadolinium and/or any other contraindication to perform
a MRI

8. Have any other comorbid conditions that preclude participation

9. Have been previously treated with cladribine

10. Have previously been treated with ocrelizumab, alemtuzumab, rituximab, or daclizumab

11. Have received treatment with natalizumab during the last 6 months

12. Are currently receiving immunosuppressive or myelosuppressive therapy, e.g.,
methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic treatment
with systemic corticosteroids

13. Have received treatment with immunosuppressive or myelosuppressive therapy during the
last 6 months

14. Have received chronic treatment with systemic corticosteroids during the last 4 weeks

15. Have moderate or severe hepatic impairment (Child-Pugh score >6)

16. Have moderate or severe renal impairment (creatinine clearance <60 mL per minute)

17. Are pregnant or unwilling or unable to use effective contraception during cladribine
tablets dosing and for 6 months after the last dose in each treatment course

18. Are intending to breastfeed on a cladribine tablet treatment day and/or during the 10
days after the last cladribine tablet dose.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Relapsing-Remitting

Multiple Sclerosis

Intervention(s)

Drug: Cladribine

Primary Outcome(s)

Changes in the CSF levels of lymphocyte subtypes and markers of neuronal injury during treatment with cladribine tablets in patients with RMS [Time Frame: 5 weeks, 10 weeks, 1 year, or 2 years]

Secondary ID(s)

MS700568_0049-201906092

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

EMD Serono