Exploring the wearing-off effects of anti-CD20 therapies in Multiple Sclerosis
The Wearing-off Effect of Anti-CD20 Therapies in Patients With Multiple Sclerosis
This study is trying to see how the effects of anti-CD20 therapies, like ocrelizumab and ofatumumab, change over time for people with Multiple Sclerosis and how it impacts their daily lives.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 21 Years to 85 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Locations | 1 site (East Hanover, New Jersey) |
| Trial ID | NCT06121349 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the wearing-off effects associated with anti-CD20 therapies, specifically ocrelizumab (OCR) and ofatumumab (OMB), in patients with Multiple Sclerosis (MS). Participants will be surveyed at four different time points during their treatment cycles to assess various MS symptoms, including fatigue, mobility, pain, depression, and cognition. The study will also evaluate the impact of worsening MS symptoms on patients' health-related quality of life and work productivity using validated scales. The goal is to better understand the prevalence and nature of these wearing-off effects in MS patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older with a self-reported diagnosis of relapsing or secondary progressive Multiple Sclerosis who have been on OCR or OMB for the specified duration.
Not a fit: Patients currently participating in other clinical trials involving MS drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into managing wearing-off effects in MS patients, potentially improving their quality of life.
How similar studies have performed: While the specific focus on wearing-off effects in this context may be novel, there have been other studies examining the efficacy of anti-CD20 therapies in MS, indicating a growing interest in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: OCR sample: * Self-reported diagnosis of RMS, SPMS or CIS * ≥21 years old at the time of initial contact * Under treatment with OCR at the time of initial contact * Have been on OCR for ≥ 1 year at the time of initial contact (i.e., prevalent users) * Able to answer the questionnaires in English OMB sample * Self-reported diagnosis of RMS, SPMS or CIS * ≥21 years old at the time of initial contact * Under treatment with OMB at the time of initial contact * Have been on OMB for ≥6 months at the time of initial contact (i.e., prevalent users) * Able to answer the questionnaires in English Exclusion Criteria: OCR sample: * Currently participating in a clinical trial involving MS drugs * Last Ocrevus infusion was less than 3 months back OMB sample: Currently participating in a clinical trial involving MS drugs
Where this trial is running
East Hanover, New Jersey
- Novartis Investigational site — East Hanover, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.