To identify the effect of psoriasis and the treatment with biologics on the pre-pregnancy uterine immune environment of psoriasis patients.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in phenotype and function of immune cells present in the menstrual
blood between patients with psoriasis using biologics, patients with psoriasis
using methotrexate, patients with psoriasis using only topical medication and
healthy controls.
Secondary outcome
Not applicable
Background summary
For a successful pregnancy a perfect immunological balance is required, because
there has to be tolerance towards a fetus which is partly from the father, and
at the same time, protection of the mother and fetus against infection. This
immunological balance is regulated by immune cells in the uterus.
The immune system is dysregulated in women with psoriasis. This can negatively
affect pregnancy outcomes. In addition, it is hypothesized that the
increasingly used biologics can interfere in or restore the immunological
balance. However, the fundamental mechanisms on how psoriasis and biologics
affect pregnancy are unknown. To get more insight in this, a non-invasive
method to obtain immune cells from the pre-pregnancy endometrium will be used
to study the effect of psoriasis and biologics on the local uterine immune
environment.
Study objective
To identify the effect of psoriasis and the treatment with biologics on the
pre-pregnancy uterine immune environment of psoriasis patients.
Study design
Characterisation of the immune cells present in menstrual and peripheral blood
of patients with psoriasis using biologics, in patients with psoriasis using
methotrexate, in patient with psoriasis using topical treatment and healthy
controls.
Study burden and risks
The risk associated with this study is minimal.
The patients and healthy controls will be asked for blood withdrawal of 3 tubes
(total of 20 mL). The blood withdrawal with be done by qualified personnel.
Therefore the risks related to the withdrawal of the peripheral blood will be
minimal.
The use of the menstrual cup to collect menstrual blood is safe. However, the
use of menstrual cups were associated with an increased risk on expulsion of
IUDs, which is why we exclude participants with an IUD from this study . In
addition, collection requires some time and effort.
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
Patients:
In order to be eligible to participate in this study, a patient must meet all
of the following criteria:
- Women aged 18-45 year
- Diagnosis of psoriasis
- Using adalimumab, ustekinumab, ixekizumab, guselkumab or methotrexate for at
least 6 months, or topical treatment.
Healthy controls:
In order to be eligible to participate in this study, a healthy control must
meet the following criteria:
- Women aged 18-45 year
Exclusion criteria
Patients:
A potential patient who meets any of the following criteria will be excluded
from participation in this study:
- Use of other birth control than oral contraceptives (i.e., (copper)
intra-uterine devices (IUD))
- Immune mediated co-morbidities (e.g., inflammatory bowel disease, rheumatoid
arthritis) or diabetes mellitus
- Smoking
- Participants who are not capable of signing the informed consent
Only for patients treated with biologics the following is also applicable:
- Primary indication of biologic is not psoriasis.
- Use of other immunomodulating medication, such as methotrexate, or
antidepressants.
Only for patients treated with methotrexate the following is also applicable:
- Primary indication of methotrexate is not psoriasis.
- Use of other immunomodulating medication, such as biologics, or
antidepressants.
Only for patients with topical treatment the following is also applicable:
- Use of any systemic medication that is prescribed for psoriasis, such as
biologics or methotrexate, or antidepressants.
Healthy controls:
A potential healthy control who meets any of the following criteria will be
excluded from participation in this study:
- Use of other birth control than oral contraceptives (i.e., copper
intra-uterine device (IUD))
- Use of immunomodulating medication or antidepressants
- Diagnosed with an autoimmune disease or diabetes mellitus
- Known disorder of reproduction
- Smoking
- Participants who are not capable of signing the informed consent
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87112.091.24 |