A Study of Suboptimally Controlled Participants Previously Taking Injectable DMDs for RMS (CLICK-MS)

NCT03933215 | Completed Results

• 1 other identifier: MS700568_0078
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 18

Brief Summary

To evaluate the effectiveness, patient-reported outcomes (PROs) and safety of cladribine tablets in participants with relapsing forms of multiple sclerosis (RMS) including relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (aSPMS),who transition to cladribine tablets after suboptimal response to any injectable disease-modifying drugs (DMDs) approved in the United States (US) for RMS in a real-world setting.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Cladribine Tablets; Observational; Mavenclad

Outcome Measures

Primary Outcomes (1)

• Annualized Relapse Rate (ARR)

  The qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than \[\>\] 24 hours, no fever, infection, injury, adverse events (AEs), and preceded by a stable or improving neurological state for more than or equal to \[\>=\] 30 days).

  Baseline (Month 0) up to 24 Months

Secondary Outcomes (23)

• Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24

  Baseline (Month 0), Month 6, 12 and 24

• Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score at Month 6, 12 and 24

  Baseline (Month 0), Month 6, 12 and 24

• Change From Baseline in Modified Fatigue Impact Scale - 5-item Version (MFIS-5) Total Score at Month 6, 12 and 24

  Baseline (Month 0), Month 6, 12 and 24

• Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24

  Baseline (Month 0), Month 6, 12 and 24

• Change From Baseline in Percent Work Time Missed Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24

  Baseline (Month 0), Month 6, 12 and 24

Study Arms (1)

Cladribine

Drug: Cladribine

Interventions

Cladribine DRUG

Participants received cladribine tablets as per investigator discretion and as per United States approved label: 3.5 milligram/kilogram (mg/kg) body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.

Cladribine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with Multiple Sclerosis and experienced suboptimal response (lack of effectiveness, intolerability, poor adherence) to prior treatment with an injectable DMD.

You may qualify if:

• Male or female participants greater than or equal to (\>=)18 years
• Signed informed consent
• Have diagnosis of RMS including RRMS and aSPMS and satisfy the approved indication for cladribine tablets as per United States Prescribing Information (USPI)
• Have time since diagnosis of RMS of at least 12 months
• Had received their last previous injectable disease-modifying drug (DMD) for at least 3 months
• Have decided to initiate treatment with cladribine tablets during routine clinical care
• Meet criteria as per the approved USPI
• Have access to a valid e-mail address
• In the opinion of the Investigator, experienced suboptimal response (lack of effectiveness, intolerability, poor adherence) to injectable DMD treatment

You may not qualify if:

• Have been previously treated with cladribine in any dosing form
• Transitioning from previous injectable DMD solely for administrative reasons such as relocation
• Have comorbid conditions that preclude participation
• Have any clinical condition or medical history noted as contraindication on USPI
• Are currently participating in an interventional clinical trial
• Pregnant or breastfeeding women, women who plan to become pregnant or men whose partner plans to become pregnant during the cladribine treatment period

Sponsors & Collaborators

• EMD Serono Research & Development Institute, Inc.: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (18)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

HCA Research Institute

Englewood, Colorado, 80113, United States

Location

Advanced Neurosciences Research

Fort Collins, Colorado, 80528, United States

Location

Prairie Education & Research

Springfield, Illinois, 62702, United States

Location

Fort Wayne Neurological Center

Fort Wayne, Indiana, 46804, United States

Location

College Park Family Care Center

Overland Park, Kansas, 66212, United States

Location

The Elliot Lewis Center for Multiple Sclerosis Care, LLC

Wellesley, Massachusetts, 02481, United States

Location

UMASS - Neurology

Worcester, Massachusetts, 01655, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Memorial Healthcare

Owosso, Michigan, 48867, United States

Location

Minneapolis Clinic of Neurology - Neurology

Minneapolis, Minnesota, 55422, United States

Location

Guilford Neurologic Associates

Greensboro, North Carolina, 27405, United States

Location

Neurology Center of San Antonio

San Antonio, Texas, 78258, United States

Location

Blacksburg Neurology, PC

Christiansburg, Virginia, 24073, United States

Location

Neurological Associates

Richmond, Virginia, 23229, United States

Location

VCU Medical Center - Pediatric Neurology

Richmond, Virginia, 23298-0211, United States

Location

Sentara Ambulatory Care Center

Virginia Beach, Virginia, 23456, United States

Location

MS Center of Evergreen

Kirkland, Washington, 98034, United States

Location

Related Publications (1)

• Miravalle AA, Katz J, Robertson D, Hayward B, Harlow DE, Lebson LA, Sloane JA, Bass AD, Fox EJ. CLICK-MS and MASTER-2 Phase IV trial design: cladribine tablets in suboptimally controlled relapsing multiple sclerosis. Neurodegener Dis Manag. 2021 Apr;11(2):99-111. doi: 10.2217/nmt-2020-0059. Epub 2021 Feb 1.

  PMID: 33517769 BACKGROUND

Related Links

• Trial Awareness and Transparency website
• US Medical Information website, Medical Resources

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Cladribine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Limitations and Caveats

There are methods to adjustment for missing-not-at-random, but these methods are varied and inconsistent, especially with high missingness. Knowing we have low counts for many outcomes, we reported the data that we have, accepting that there will be patients with missing data who are missing assessments due to sickness or other non-random reasons.

Results Point of Contact

• Title: Communication Center
• Organization: Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany

service@emdgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  EMD Serono Inc., the biopharmaceutical division of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 1, 2019
• Study Start: May 21, 2019
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: April 29, 2025
• Results First Posted: April 29, 2025

Record last verified: 2025-04

Locations

US (18)