Please select the eligibility criteria that correspond to the clinical trial below.
Title: Multicenter Randomised Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients
Brief Summary: The systemic treatments for moderate to severe atopic dermatitis (AD) are limited to phototherapy and cyclosporine with the risks respectively of either carcinoma, or hypertension or nephropathy.

Methotrexate was effective in 75% of moderate to severe AD patients with good tolerance in an open retrospective study.

We want to confirm our observations: a non inferiority multicenter clinical trial, methotrexate versus cyclosporine, will be conducted in 100 patients for 24 weeks.


Options:
A: Inclusion Criteria:

1. Male or female, 18 years or older;
2. Chronic AD that had been present for at least 3 years before the screening visit;
3. Patients with documented recent history (within 6 months before the screening visit) of inadequate response to out-patient treatment with topical medications, or for whom topical treatments were otherwise inadvisable;
4. Willing and able to comply with all clinic visits and study-related procedures.

Exclusion Criteria:

1. Prior participation in a Dupilumab clinical trial;
2. Treatment with an investigational drug within 8 weeks or within 5 half-lives before the baseline visit;
3. The following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, will likely require such treatment(s) during the first 4 weeks of study treatment:

   * Systemic corticosteroids;
   * Immunosuppressive/immunomodulating drugs;
   * Phototherapy for AD;
4. Treatment with topical corticosteroids, tacrolimus and/or pimecrolimus within 1 week before the baseline visit;
5. Treatment with certain biologics;
6. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks before the baseline visit;
7. Planned major surgical procedure during the participant's participation in this study;
8. Participant was a member of the investigational team or his/her immediate family;
9. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
10. Pregnant or breast-feeding women or women planning to become pregnant or breastfeed during the study;

Note: The information listed above is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial therefore not all inclusion/exclusion criteria are listed.
B: Inclusion Criteria:

* Patients aged \> 18 years old.
* Both genders eligible for study.
* Moderate to severe AD.
* Scorad \> 15.
* Participants must use a contraceptive method during the trial and for 3 months after the end of the trial for female and 5 months for male participants.
* Participants must be able to understand and sign the Informed Consent, and comply with all aspects of the protocol.
* Patients must be registered in a social security system or with a health insurance coverage.

Exclusion Criteria:

* Pregnant or lactating women.
* Evolutive skin disease.
* Patients with a clinically significant disease (chronic, recurrent or active).
* Systemic corticotherapy or immunosuppressive treatment during the previous month, or local corticoid the week before the inclusion.
* Contra-indication to methotrexate and cyclosporine.
* Exposure to phototherapy: cumulative dose \> 2000 J/cm2.
* Patients deprived of their civic rights, in custody, or subject to a tutorial, judiciary or administrative decision.
* Patients under a protection measure.
* Patients in a critical medical situation.
* Patients with a personal situation evaluated by the investigator as unable to give optimal participation to the study, or where the study could constitute a risk for the patient.
C: Inclusion Criteria:

1. Chronic AD that has been present for at least 3 years before the screening visit;
2. ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits;
3. Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).

Exclusion Criteria:

1. Participation in a prior Dupilumab clinical study.
2. Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit;
3. Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:

   * Immunosuppressive/ immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
   * Phototherapy for AD
4. Regular use (more than 2 visits per week) of a tanning booth/ parlor within 4 weeks of the screening visit;
5. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;
6. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening;
7. Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit;
8. Active chronic or acute infection requiring systemic treatment within 2 weeks before the baseline visit;
9. Known or suspected history of immunosuppression;
10. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study;
11. Women unwilling to use adequate birth control, if of reproductive potential and sexually active.

Note: The information listed above is not intended to contain all considerations relevant to a participant's potential participation in this clinical trial therefore not all inclusion/ exclusion criteria are listed.
D: The inclusion criteria included, but were not limited to, the following:

1. Chronic Atopic Dermatitis that had been present for at least 3 years
2. History of inadequate response to out-patient treatment with topical medications, or for whom topical treatments were otherwise inadvisable (e.g, because of important side effects or safety risks)
3. Willing and able to comply with all clinic visits and study-related procedures

The exclusion criteria included, but were not limited to, the following:

1. Prior treatment with dupilumab (REGN668/SAR231893)
2. Presence of certain laboratory abnormalities at the screening visit
3. Treatment with an investigational drug within 8 weeks of baseline visit
4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
5. Certain other treatments and medical procedures undertaken within a particular time frame prior to the baseline visit
6. Known history of human immunodeficiency virus (HIV) infection
7. History of malignancy within 5 years before the baseline visit (with certain exceptions)
8. Planned surgical procedure during the length of the study
9. High risk of parasite infection
10. Any other medical or psychological condition that in the opinion of the investigator or the sponsor's medical monitor, would place the participants at risk, interfere with participation in the study or interfere with interpretation of study results
11. Pregnant or breast-feeding women

Answer: B