Patient Real-world Clinical, Neurological, Tolerability, and Safety Ou
Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®: A Retrospective Study (PROTRACT)
What it found
We found no results in the registry or in papers.
This trial finished 9 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Interferon beta-1a
Interferon alpha/beta receptor agonist
- Dimethyl fumarate
Kelch-like ECH-associated protein 1 inhibitor
What it measured
Main measures
NEDA-2
12 months
RelapsesMRI lesionsSafety
Other measures (3)
Clinical differences between the two treatment groups
12 months
RelapsesNeurological differences between two treatment groups
12 months
MRI lesionsProportion of individuals within each treatment group who discontinued, stratified by reason
12 months
Safety
Who could take part
Relapsing MS · 18 to 55
Show the full criteria
Inclusion criteria
1. Diagnosis of Clinically Isolated Syndrome (CIS) or a relapse remitting multiple sclerosis (RRMS). 2. Age between 18 - 55 years at the time of index. 3. No evidence of prior disease modifying therapy for MS. 4. Initiated treatment with either Rebif or Tecfidera at the time of index. Patient is considered to have initiated treatment if they took at least one dose. Treatment must have been initiated after the product was approved by the FDA. 5. Availability of a high quality baseline MRI brain scan, which must have occurred between 6 months prior to the index date to 2 weeks after the index date. 6. Availability of clinical data in the patient's record for the full study observation period, as defined in the primary objective.
Exclusion criteria
1. Pregnant at any time during the study observation period. 2. Presence of pre-existing medical conditions known to be associated with brain pathology (cerebrovascular and neurodegenerative diseases, presence of active alcohol or substance abuse). 3. Patient discontinued initial therapy prior to completing 1 year of treatment due to a reason other than disease activity, tolerability, or safety (e.g. financial, convenience, preference, etc.). 4. Phase III registrational trial patients
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to evaluate the proportion of patients who demonstrate no medical need to discontinue therapy among DMT-naïve patients with relapsing forms of multiple sclerosis after 1 year of treatment with Rebif 44 mcg tiw or with Tecfidera 240 mg bid based on real-world data.
Loading reviews and guidelines…
Related trials
- A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dime
Phase 3 · Not yet recruiting
Still running
- Disease Modifying Therapies Withdrawal in Inactive Relapsing-remitting
Phase 3 · Not yet recruiting
Still running
- Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
Recruiting
Still running
- Observational Study of Persistence on Bafiertam Treatment in Routine C
Stopped early
Stopped
- A Study of Dimethyl Fumarate (DMF) in Relapsing Forms of Multiple Scle
Phase 4 · Completed
No results found
- Prospective Evaluation of De-Escalation From antiCD-20 Therapies to Di
Running, not recruiting
Still running
History
Started
Feb 2016
Main results due
Apr 2017
Finished
Feb 2018