NCT03933215Completed
A Study of Suboptimally Controlled Participants Previously Taking Injectable DMDs for RMS (CLICK-MS)
Cladribine Tablets: Observational Evaluation of Effectiveness and PROs in Suboptimally Controlled Patients Previously Taking Injectable DMDs for RMS (CLICK-MS)
Source: ClinicalTrials.gov · Last updated 29 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 100 (actual)
- First submitted
- 29 Apr 2019
- Start date
- 21 May 2019
- Primary completion date
- 30 Mar 2024
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.
- Diseases
- Multiple sclerosis
- NCT number
- NCT03933215
What you commit to
- Study type: Observational
- Participants enrolled: 100
- From 21 May 2019 to the primary completion date, 30 Mar 2024
- 18 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have been previously treated with cladribine in any dosing form
- Transitioning from previous injectable DMD solely for administrative reasons such as relocation
Other illness
- Have comorbid conditions that preclude participation
- Have any clinical condition or medical history noted as contraindication on USPI
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Blacksburg Neurology, PC Coordinator of this site? Confirm its status | Christiansburg | United States | Unknown status |
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| HCA Research Institute Coordinator of this site? Confirm its status | Englewood | United States | Unknown status |
| Advanced Neurosciences Research Coordinator of this site? Confirm its status | Fort Collins | United States | Unknown status |
| Fort Wayne Neurological Center Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| Guilford Neurologic Associates Coordinator of this site? Confirm its status | Greensboro | United States | Unknown status |
| MS Center of Evergreen Coordinator of this site? Confirm its status | Kirkland | United States | Unknown status |
| University of Arkansas for Medical Sciences Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Minneapolis Clinic of Neurology - Neurology Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| College Park Family Care Center Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
| Memorial Healthcare Coordinator of this site? Confirm its status | Owosso | United States | Unknown status |
| VCU Medical Center - Pediatric Neurology Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Neurological Associates Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Neurology Center of San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Prairie Education & Research Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Sentara Ambulatory Care Center Coordinator of this site? Confirm its status | Virginia Beach | United States | Unknown status |
| The Elliot Lewis Center for Multiple Sclerosis Care, LLC Coordinator of this site? Confirm its status | Wellesley | United States | Unknown status |
| UMASS - Neurology Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.