Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05528666
Other study ID # COMB157G3001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 9, 2021
Est. completion date September 17, 2021

Study information

Verified date November 2022
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study was a retrospective, non-interventional, cross-sectional, multi-cohort study of patients clinically diagnosed with RMS (RRMS and SPMS). Patients were classified according to the immediate previous treatment in two groups, those who were prescribed with high efficacy treatments (HETs) and those who were prescribed with non-high efficacy treatments (non-HETs). HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod; and non-HETs include molecules classified as with moderate or modest efficacy such as: interferons, glatiramer acetate, dimethyl fumarate and teriflunomide.


Description:

The study cohort consisted of RMS patients identified in the Adelphi Real World MS DSP, which was current up until the Q2/2021. The study was using waves VI-IX of the Adelphi DSP dataset. Study period: Q1 2017 - Q1 & Q2 2021 (waves VI-IX of Adelphi DSP dataset). Identification period: Q1 2017 - Q1 & Q2 2021 (waves VI-IX of Adelphi DSP dataset). Index date: defined as the dates when the surveys were carried out (Q1 2017 - Q1 & Q2 2021).


Recruitment information / eligibility

Status Completed
Enrollment 4361
Est. completion date September 17, 2021
Est. primary completion date September 17, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Patients included in the database with a diagnosis of RRMS and SPMS. - Patients with current treatment at the index date. - Patients with previous treatment at the index date. - Patients to whom the physician decided to switch the treatment from the previous treatment to current treatment at the index date. - Patients (males & females) with 18 years or older at index date. Exclusion Criteria: - Patients included in the database with the diagnosis of primary progressive MS (PPMS). - Patients with other major neurological or psychiatric condition, which could potentially hinder the analysis.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
High Efficacy Therapy (HET)
HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod.
Non High Efficacy Therapy (Non-HET)
Non-HETs include molecules classified as with moderate or modest efficacy such as: interferons, glatiramer acetate, dimethyl fumarate and teriflunomide.

Locations

Country Name City State
United States Novartis Investigative Site East Hanover New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients who were switched based on risk perception (infections, malignancies, others) Proportion of patients who were switched based on risk perception (infections, malignancies, others) were reported. Throughout the study, approximately 5 years (2017 to 2021)
Secondary Number of patients with ranking of the frequency of switches due to risk perception Proportion of patients who were switched based on risk perception (infections, malignancies, others) were reported. Throughout the study, approximately 5 years (2017 to 2021)
Secondary Proportion of patients who switched due to lack of efficacy Proportion of patients who switched due to lack of efficacy due to new or enlarging lesions on MRI, increase in the frequency and/or severity of the relapses, progression in physical disability measured by EDSS or patient compliance issues between groups were reported. Throughout the study, approximately 5 years (2017 to 2021)
Secondary Proportion of patients who changed treatment group versus patients who continued in the same treatment group Proportion of patients who changed treatment group versus patients who continued in the same treatment group were reported. Throughout the study, approximately 5 years (2017 to 2021)
Secondary Number of relapses Number of relapses were reported. Baseline
Secondary Expanded Disability Status Scale (EDSS) The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Baseline
Secondary Age Age information reported Baseline
Secondary Gender Gender information reported Baseline
Secondary Number of patients: Employment status Patient employment status reported Baseline
Secondary Number of patients with Initial MS diagnosis Number of patients with Initial MS diagnosis were reported. Baseline
Secondary Number of patients with Current MS diagnosis Number of patients with Current MS diagnosis were reported. Baseline
Secondary Number of patients with previous disease modifying treatment Number of patients with previous disease modifying treatment were reported. Baseline
See also
  Status Clinical Trial Phase
Completed NCT03608527 - Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis N/A
Recruiting NCT05532943 - Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis Phase 1/Phase 2
Completed NCT02486640 - Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
Completed NCT01324232 - Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis Phase 2
Completed NCT04546698 - 5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
Active, not recruiting NCT04380220 - Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
Completed NCT02835677 - Integrating Caregiver Support Into MS Care N/A
Completed NCT03686826 - Feasibility and Reliability of Multimodal Evoked Potentials
Recruiting NCT05964829 - Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis N/A
Withdrawn NCT06021561 - Orofacial Pain in Multiple Sclerosis
Completed NCT03653585 - Cortical Lesions in Patients With Multiple Sclerosis
Recruiting NCT04798651 - Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis N/A
Active, not recruiting NCT05054140 - Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis Phase 2
Completed NCT05447143 - Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis N/A
Recruiting NCT06195644 - Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients Phase 1
Completed NCT04147052 - iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis N/A
Completed NCT03594357 - Cognitive Functions in Patients With Multiple Sclerosis
Completed NCT03591809 - Combined Exercise Training in Patients With Multiple Sclerosis N/A
Completed NCT03269175 - BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies Phase 4
Completed NCT02845635 - MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis