Trial Outcomes & Findings for Establish Tolerance In MS With Peptide-Coupled, Peripheral Blood Mononuclear Cells (NCT NCT01414634)
NCT ID: NCT01414634
Last Updated: 2015-05-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
12 months
Results posted on
2015-05-04
Participant Flow
Participant milestones
| Measure |
ETIMS 1x10^3
ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
|
ETIMS 1x10^5
ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
|
ETIMS 1x10^7
ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
|
ETIMS 1x10^8
ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
|
ETIMS 5x10^8
ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
|
ETIMS 1x10^9
ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
|
ETIMS 2.5x10^9
ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
|
ETIMS 3x10^9
ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
1
|
1
|
2
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
1
|
1
|
2
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Establish Tolerance In MS With Peptide-Coupled, Peripheral Blood Mononuclear Cells
Baseline characteristics by cohort
| Measure |
ETIMS Dose Escalation
n=9 Participants
ETIMS: injection of peptide-coupled PBMC by i.v. infusion
|
|---|---|
|
Age, Continuous
|
42 years
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 3 months after treatmentOutcome measures
| Measure |
ETIMS Dose Escalation
n=9 Participants
ETIMS: injection of peptide-coupled PBMC by i.v. infusion
|
|---|---|
|
Number of Adverse Events
|
14 Number of AE
|
Adverse Events
ETIMS 1x10^3
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
ETIMS 1x10^5
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
ETIMS 1x10^7
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
ETIMS 1x10^8
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
ETIMS 5x10^8
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
ETIMS 1x10^9
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
ETIMS 2.5x10^9
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ETIMS 3x10^9
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ETIMS 1x10^3
n=1 participants at risk
ETIMS: injection of peptide-coupled PBMC by i.v. infusion
|
ETIMS 1x10^5
n=1 participants at risk
ETIMS: injection of peptide-coupled PBMC by i.v. infusion
|
ETIMS 1x10^7
n=1 participants at risk
ETIMS: injection of peptide-coupled PBMC by i.v. infusion
|
ETIMS 1x10^8
n=1 participants at risk
ETIMS: injection of peptide-coupled PBMC by i.v. infusion
|
ETIMS 5x10^8
n=1 participants at risk
ETIMS: injection of peptide-coupled PBMC by i.v. infusion
|
ETIMS 1x10^9
n=2 participants at risk
ETIMS: injection of peptide-coupled PBMC by i.v. infusion
|
ETIMS 2.5x10^9
n=1 participants at risk
ETIMS: injection of peptide-coupled PBMC by i.v. infusion
|
ETIMS 3x10^9
n=1 participants at risk
ETIMS: injection of peptide-coupled PBMC by i.v. infusion
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
diverticulitis of sigma
|
100.0%
1/1 • Number of events 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Other adverse events
| Measure |
ETIMS 1x10^3
n=1 participants at risk
ETIMS: injection of peptide-coupled PBMC by i.v. infusion
|
ETIMS 1x10^5
n=1 participants at risk
ETIMS: injection of peptide-coupled PBMC by i.v. infusion
|
ETIMS 1x10^7
n=1 participants at risk
ETIMS: injection of peptide-coupled PBMC by i.v. infusion
|
ETIMS 1x10^8
n=1 participants at risk
ETIMS: injection of peptide-coupled PBMC by i.v. infusion
|
ETIMS 5x10^8
n=1 participants at risk
ETIMS: injection of peptide-coupled PBMC by i.v. infusion
|
ETIMS 1x10^9
n=2 participants at risk
ETIMS: injection of peptide-coupled PBMC by i.v. infusion
|
ETIMS 2.5x10^9
n=1 participants at risk
ETIMS: injection of peptide-coupled PBMC by i.v. infusion
|
ETIMS 3x10^9
n=1 participants at risk
ETIMS: injection of peptide-coupled PBMC by i.v. infusion
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
metallic flavor during infusion of study drug
|
0.00%
0/1
|
100.0%
1/1 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/1
|
0.00%
0/1
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/1
|
0.00%
0/1
|
|
Infections and infestations
Common cold
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
100.0%
1/1 • Number of events 1
|
100.0%
1/1 • Number of events 1
|
0.00%
0/2
|
0.00%
0/1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/1
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Irritation of punctured vein
|
0.00%
0/1
|
100.0%
1/1 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/1
|
0.00%
0/1
|
|
Nervous system disorders
Migraine
|
0.00%
0/1
|
100.0%
1/1 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/1
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1
|
0.00%
0/1
|
100.0%
1/1 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/1
|
0.00%
0/1
|
|
Nervous system disorders
Vision disturbance
|
0.00%
0/1
|
0.00%
0/1
|
100.0%
1/1 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/1
|
0.00%
0/1
|
|
Nervous system disorders
Dysaesthesia/pain in one hand
|
0.00%
0/1
|
0.00%
0/1
|
100.0%
1/1 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Gastric pain
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
100.0%
1/1 • Number of events 1
|
0.00%
0/2
|
0.00%
0/1
|
0.00%
0/1
|
|
Cardiac disorders
Syncope
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
|
Nervous system disorders
Paravertebral dysaesthesia
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
0.00%
0/1
|
Additional Information
Roland Martin
Neuroimmunology and MS Research, Department of Neurology, University Hospital Zürich, 8091 Zürich, Switzerland
Phone: 044 255 11 25
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place