Trial Outcomes & Findings for MAIN STUDY: SWITCH SUB-STUDY: SWITCH-JCV (NCT NCT01970410)
NCT ID: NCT01970410
Last Updated: 2023-01-30
Results Overview
Number of patients relapses free by month 24.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
55 participants
Primary outcome timeframe
24 months
Results posted on
2023-01-30
Participant Flow
Participant milestones
| Measure |
Teriflunomide
Oral teriflunomide treatment 14 mg a day 28 ± 7 days after last natalizumab infusion.
|
|---|---|
|
Main Study
STARTED
|
55
|
|
Main Study
Baseline Procedures
|
55
|
|
Main Study
COMPLETED
|
28
|
|
Main Study
NOT COMPLETED
|
27
|
|
Sub-Study
STARTED
|
41
|
|
Sub-Study
COMPLETED
|
36
|
|
Sub-Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Row population differs from the Overall as there was a sub study to the main study. Of the 55 participants who partook in the main study, 36 participated in the sub-study.
Baseline characteristics by cohort
| Measure |
Teriflunomide
n=55 Participants
Oral teriflunomide treatment 14 mg a day 28 ± 7 days after last natalizumab infusion.
|
|---|---|
|
Age, Continuous
Main Study
|
47.0 Years
n=55 Participants
|
|
Age, Continuous
Sub-Study
|
49.13 Years
STANDARD_DEVIATION 9.46 • n=36 Participants • Row population differs from the Overall as there was a sub study to the main study. Of the 55 participants who partook in the main study, 36 participated in the sub-study.
|
|
Sex: Female, Male
Main Study · Female
|
42 Participants
n=55 Participants
|
|
Sex: Female, Male
Main Study · Male
|
13 Participants
n=55 Participants
|
|
Sex: Female, Male
Sub-Study · Female
|
28 Participants
n=36 Participants • Row population differs from the Overall as there was a sub study to the main study. Of the 55 participants who partook in the main study, 36 participated in the sub-study.
|
|
Sex: Female, Male
Sub-Study · Male
|
8 Participants
n=36 Participants • Row population differs from the Overall as there was a sub study to the main study. Of the 55 participants who partook in the main study, 36 participated in the sub-study.
|
|
Race (NIH/OMB)
Main Study · American Indian or Alaska Native
|
0 Participants
n=55 Participants
|
|
Race (NIH/OMB)
Main Study · Asian
|
0 Participants
n=55 Participants
|
|
Race (NIH/OMB)
Main Study · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=55 Participants
|
|
Race (NIH/OMB)
Main Study · Black or African American
|
2 Participants
n=55 Participants
|
|
Race (NIH/OMB)
Main Study · White
|
53 Participants
n=55 Participants
|
|
Race (NIH/OMB)
Main Study · More than one race
|
0 Participants
n=55 Participants
|
|
Race (NIH/OMB)
Main Study · Unknown or Not Reported
|
0 Participants
n=55 Participants
|
|
Race (NIH/OMB)
Sub-Study · American Indian or Alaska Native
|
0 Participants
n=36 Participants • Row population differs from the Overall as there was a sub study to the main study. Of the 55 participants who partook in the main study, 36 participated in the sub-study.
|
|
Race (NIH/OMB)
Sub-Study · Asian
|
0 Participants
n=36 Participants • Row population differs from the Overall as there was a sub study to the main study. Of the 55 participants who partook in the main study, 36 participated in the sub-study.
|
|
Race (NIH/OMB)
Sub-Study · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=36 Participants • Row population differs from the Overall as there was a sub study to the main study. Of the 55 participants who partook in the main study, 36 participated in the sub-study.
|
|
Race (NIH/OMB)
Sub-Study · Black or African American
|
1 Participants
n=36 Participants • Row population differs from the Overall as there was a sub study to the main study. Of the 55 participants who partook in the main study, 36 participated in the sub-study.
|
|
Race (NIH/OMB)
Sub-Study · White
|
35 Participants
n=36 Participants • Row population differs from the Overall as there was a sub study to the main study. Of the 55 participants who partook in the main study, 36 participated in the sub-study.
|
|
Race (NIH/OMB)
Sub-Study · More than one race
|
0 Participants
n=36 Participants • Row population differs from the Overall as there was a sub study to the main study. Of the 55 participants who partook in the main study, 36 participated in the sub-study.
|
|
Race (NIH/OMB)
Sub-Study · Unknown or Not Reported
|
0 Participants
n=36 Participants • Row population differs from the Overall as there was a sub study to the main study. Of the 55 participants who partook in the main study, 36 participated in the sub-study.
|
|
Region of Enrollment
United States
|
36 participants
n=36 Participants • Row population differs from the Overall as there was a sub study to the main study. Of the 55 participants who partook in the main study, 36 participated in the sub-study.
|
|
Duration of prior Natalizumab in years
|
2.8 Years
n=55 Participants
|
|
Duration of prior NTZ in years
|
3.71 Years
n=36 Participants • Row population differs from the Overall as there was a sub study to the main study. Of the 55 participants who partook in the main study, 36 participated in the sub-study.
|
PRIMARY outcome
Timeframe: 24 monthsNumber of patients relapses free by month 24.
Outcome measures
| Measure |
Teriflunomide
n=55 Participants
Oral teriflunomide treatment 14 mg a day 28 ± 7 days after last Natalizumab infusion.
|
|---|---|
|
MAIN STUDY: Number of Participants Relapse Free at 24 Months
|
25 Participants
|
SECONDARY outcome
Timeframe: 24 monthsMean time to first Gadolinium "enhancing" (GAD+) lesion in months.
Outcome measures
| Measure |
Teriflunomide
n=55 Participants
Oral teriflunomide treatment 14 mg a day 28 ± 7 days after last Natalizumab infusion.
|
|---|---|
|
MAIN STUDY: Time to Return of Radiological Evidence of Multiple Sclerosis Activity With New Gadolinium "Enhancing" (Gd+) Lesions on Cranial MRI.
|
19.6 Months
Standard Error 1.1
|
SECONDARY outcome
Timeframe: 24 monthsMean time to 3-month sustained disability worsening (SDW) in months. SDW is defined as an increase of ≥ 1 point for patients with EDSS of 1.0-5.0, and ≥ 0.5 points for patients with an EDSS of 5.5-6.0, sustained for 3 months. Patients with ≥ 1 point increase in EDSS in whom a second measure was not obtained 3 months later were not included as SDW.
Outcome measures
| Measure |
Teriflunomide
n=55 Participants
Oral teriflunomide treatment 14 mg a day 28 ± 7 days after last Natalizumab infusion.
|
|---|---|
|
MAIN STUDY: Expanded Disability Status Scale (EDSS) Sustained Progression for 3 Months as Measured by at Least 0.5 Increase From Baseline or 1 in Any EDSS Set Score
|
22 Months
Standard Error 0.7
|
SECONDARY outcome
Timeframe: 24 monthsMean time of new T2 or enlarging T2 Lesions
Outcome measures
| Measure |
Teriflunomide
n=55 Participants
Oral teriflunomide treatment 14 mg a day 28 ± 7 days after last Natalizumab infusion.
|
|---|---|
|
MAIN STUDY: Mean Time to New T2 or Enlarging T2 Hyperintensities on Monthly Sentinel Brain MRIs
|
19.2 Months
Standard Error 1.1
|
POST_HOC outcome
Timeframe: 30 daysNumber of patients with a \>= 20% reduction of AJAI. The AJAI serostatus categories used in the study were negative (\<0.2), positive (0.41-0.89) and high positive (≥0.90). The 0.2-0.4 range is frequently reported as indeterminate. We defined a change of 20% or greater as a meaningful increase or decrease in the AJAI.
Outcome measures
| Measure |
Teriflunomide
n=36 Participants
Oral teriflunomide treatment 14 mg a day 28 ± 7 days after last Natalizumab infusion.
|
|---|---|
|
SUB-STUDY: Number of Patients With a Reduction of Anti-JCV Antibody Index (AJAI)
|
20 Participants
|
Adverse Events
MAIN STUDY: Teriflunomide
Serious events: 5 serious events
Other events: 47 other events
Deaths: 0 deaths
SUB-STUDY: Anti- John Cunningham Virus (JCV) Antibody Status
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MAIN STUDY: Teriflunomide
n=55 participants at risk
Oral teriflunomide treatment 14 mg a day 28 ± 7 days after last natalizumab infusion.
|
SUB-STUDY: Anti- John Cunningham Virus (JCV) Antibody Status
n=36 participants at risk
Analysis of JCV Antibody Index in MS Patients treated with teriflunomide.
|
|---|---|---|
|
Infections and infestations
Brain abscess
|
1.8%
1/55 • Number of events 1 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Infections and infestations
Empyema
|
1.8%
1/55 • Number of events 1 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Infections and infestations
Gangrenous appendicitis, ruptured
|
1.8%
1/55 • Number of events 1 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.8%
1/55 • Number of events 1 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Infections and infestations
Pneumonia
|
1.8%
1/55 • Number of events 1 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Infections and infestations
Pyelonephritis
|
1.8%
1/55 • Number of events 1 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Infections and infestations
Right pneumothorax
|
1.8%
1/55 • Number of events 1 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Skin and subcutaneous tissue disorders
Squamous cell carcinoma, left ankle
|
1.8%
1/55 • Number of events 1 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Nervous system disorders
Subfalcial herniation
|
1.8%
1/55 • Number of events 1 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Nervous system disorders
Obstructive hydrocephalus
|
1.8%
1/55 • Number of events 1 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
Other adverse events
| Measure |
MAIN STUDY: Teriflunomide
n=55 participants at risk
Oral teriflunomide treatment 14 mg a day 28 ± 7 days after last natalizumab infusion.
|
SUB-STUDY: Anti- John Cunningham Virus (JCV) Antibody Status
n=36 participants at risk
Analysis of JCV Antibody Index in MS Patients treated with teriflunomide.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Hair Thinning/ loss
|
36.4%
20/55 • Number of events 20 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Gastrointestinal disorders
Diarrhea /loose stool
|
32.7%
18/55 • Number of events 18 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Nervous system disorders
Headache
|
21.8%
12/55 • Number of events 12 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Gastrointestinal disorders
Nausea/vomiting
|
20.0%
11/55 • Number of events 11 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Nervous system disorders
Vertigo/balance difficulty/dizziness
|
20.0%
11/55 • Number of events 11 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Nervous system disorders
Fatigue
|
18.2%
10/55 • Number of events 10 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Nervous system disorders
Tingling/paresthesia
|
18.2%
10/55 • Number of events 10 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Infections and infestations
Upper respiratory infection
|
18.2%
10/55 • Number of events 10 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Nervous system disorders
Cognitive changes
|
14.5%
8/55 • Number of events 8 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Blood and lymphatic system disorders
Elevated transaminase
|
14.5%
8/55 • Number of events 8 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Musculoskeletal and connective tissue disorders
Extremity joint pain
|
14.5%
8/55 • Number of events 8 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Infections and infestations
Other infections
|
14.5%
8/55 • Number of events 8 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Nervous system disorders
Sensory decrease/disturbance
|
14.5%
8/55 • Number of events 8 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Infections and infestations
Urinary tract infection
|
14.5%
8/55 • Number of events 8 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Psychiatric disorders
Depression
|
14.5%
8/55 • Number of events 8 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Skin and subcutaneous tissue disorders
Rashes/eczema
|
12.7%
7/55 • Number of events 7 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Gastrointestinal disorders
Abdominal pain/discomfort
|
10.9%
6/55 • Number of events 6 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Psychiatric disorders
Anxiety
|
10.9%
6/55 • Number of events 6 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Eye disorders
Ophthalmic changes
|
10.9%
6/55 • Number of events 6 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Gastrointestinal disorders
Decreased appetite
|
9.1%
5/55 • Number of events 5 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Gastrointestinal disorders
Heartburn
|
9.1%
5/55 • Number of events 5 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Vascular disorders
Hypertension
|
9.1%
5/55 • Number of events 5 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Nervous system disorders
Stiffness/spasticity
|
9.1%
5/55 • Number of events 5 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Nervous system disorders
Migraine
|
9.1%
5/55 • Number of events 5 • 24 months for the main study and 5 days after blood draw for the sub-study
|
0.00%
0/36 • 24 months for the main study and 5 days after blood draw for the sub-study
|
|
Skin and subcutaneous tissue disorders
Skin irritation secondary to multiple tries to perform draw and bruising at site of blood draw
|
0.00%
0/55 • 24 months for the main study and 5 days after blood draw for the sub-study
|
5.6%
2/36 • Number of events 2 • 24 months for the main study and 5 days after blood draw for the sub-study
|
Additional Information
Director of PBSI /WC Clinical Research Program
Providence Health & Services
Phone: (503) 216-1012
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place