Trial Outcomes & Findings for Granulocytapheresis in Psoriasis (NCT NCT00714272)
NCT ID: NCT00714272
Last Updated: 2020-08-14
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
At the end of the granulocytapheresis treatment period
Results posted on
2020-08-14
Participant Flow
Participant milestones
| Measure |
A - Verum, Granulocytapheresis
Granulocytapheresis treatment
Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1: 6 treatments. One per week during the first six consecutive weeks.
|
B - Control, Sham Treatment
Sham device treatment
Treatment with a sham device, EXcorLab box 1.2: 6 sham treatments. One treatment per week during the first six consecutive weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Granulocytapheresis in Psoriasis
Baseline characteristics by cohort
| Measure |
A - Verum, Granulocytapheresis
n=2 Participants
Granulocytapheresis treatment
Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1: 6 treatments. One per week during the first six consecutive weeks.
|
B - Control, Sham Treatment
n=2 Participants
Sham device treatment
Treatment with a sham device, EXcorLab box 1.2: 6 sham treatments. One treatment per week during the first six consecutive weeks.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
40.5 years
n=99 Participants
|
49.5 years
n=107 Participants
|
45 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At the end of the granulocytapheresis treatment periodOutcome measures
| Measure |
A - Verum, Granulocytapheresis
n=2 Participants
Granulocytapheresis treatment
Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1: 6 treatments. One per week during the first six consecutive weeks.
|
B - Control, Sham Treatment
n=2 Participants
Sham device treatment
Treatment with a sham device, EXcorLab box 1.2: 6 sham treatments. One treatment per week during the first six consecutive weeks.
|
|---|---|---|
|
>/=75 % Improvement in PASI (Psoriasis Area and Severity Index) on an Intention-to-treat Basis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline to weeks 2, 6, 12 and 24Outcome measures
| Measure |
A - Verum, Granulocytapheresis
n=2 Participants
Granulocytapheresis treatment
Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1: 6 treatments. One per week during the first six consecutive weeks.
|
B - Control, Sham Treatment
n=2 Participants
Sham device treatment
Treatment with a sham device, EXcorLab box 1.2: 6 sham treatments. One treatment per week during the first six consecutive weeks.
|
|---|---|---|
|
Patients Achieving an Improvement of PASI by >/= 50%
|
0 Participants
|
0 Participants
|
Adverse Events
A - Verum, Granulocytapheresis
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
B - Control, Sham Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
A - Verum, Granulocytapheresis
n=2 participants at risk
Granulocytapheresis treatment
Treatment with a Granulocyte Adsorber, Medica Adsorber 1.1: 6 treatments. One per week during the first six consecutive weeks.
|
B - Control, Sham Treatment
n=2 participants at risk
Sham device treatment
Treatment with a sham device, EXcorLab box 1.2: 6 sham treatments. One treatment per week during the first six consecutive weeks.
|
|---|---|---|
|
General disorders
Nausea
|
50.0%
1/2 • Number of events 2 • 3 months
|
50.0%
1/2 • Number of events 3 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place