Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclerosis in Egypt

Sponsor
Hikma Pharmaceuticals LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05423769
Collaborator
(none)
30
2
18.4
15
0.8

Study Details

Study Description

Brief Summary

The purpose of this observational study is to evaluate the Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients with Relapsing-Remitting Multiple Sclerosis in Egypt

Condition or Disease Intervention/Treatment Phase

Detailed Description

This is an observational, prospective, cohort study, where no visits or intervention(s) additional to the daily practice will be performed. In the study sites, patients undergoing routine clinical care for RRMS and initiating treatment with generic Fingolimod in accordance with the approved summary of product characteristics (SPC) will be followed up and assessed for a total of 12 months.

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclerosis in Egypt
Actual Study Start Date :
Jan 19, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Proportion of patients with AEs and SAEs (including laboratory abnormalities). [up to 12 months from initiating generic Fingolimod.]

  2. Proportion of patients experiencing a relapse. [Time frame: up to 12 months period from initiating generic Fingolimod.]

  3. Time to First Relapse (TTFR) [up to 12 months from initiating generic Fingolimod.]

  4. Proportion of patients with disability progression as measured by the EDSS over time. [up to 12 months from initiating generic Fingolimod.]

Secondary Outcome Measures

  1. Proportion of patients with AEs and SAEs (including laboratory abnormalities) leading to treatment discontinuation. [up to 12 months from initiating generic Fingolimod.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Patients who initiate treatment with generic Fingolimod at baseline in accordance with the approved summary of product characteristics (SPC).

  2. Males and females who are ≥ 18 years old.

  3. Patients who had a diagnosis of RRMS per 2010 or 2017 revised McDonald criteria, who are:

  4. Newly diagnosed who had no prior Disease-Modifying Therapy (DMT), or

  5. Switched patients from Gilenya®, Novartis, or

  6. Switched patients from interferon beta (IFNβ).

  7. Patients who agree to participate in the study and provide a written informed consent.

Exclusion Criteria:
  1. Pregnant or lactating female patients and women of childbearing potential not using effective contraception.

  2. Patients lacking immunity against varicella zoster virus (VZV).

  3. Patients participating in other clinical studies.

  4. Patients who meet any of the contraindications to the administration of the study drug according to the approved SPC.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Neuropsychiatry department, Faculty of Medicine, Alexandria University Hospitals, Hadra University Hospital Alexandria Egypt
2 Faculty of medicine Ain shams Research Institute-Clinical Research Center (MASRI-CRC) Cairo Egypt

Sponsors and Collaborators

  • Hikma Pharmaceuticals LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hikma Pharmaceuticals LLC
ClinicalTrials.gov Identifier:
NCT05423769
Other Study ID Numbers:
  • HIK-SPH-2021-01
First Posted:
Jun 21, 2022
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022

Study Results

No Results Posted as of Jun 21, 2022