Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Exploratory Trial to Assess Naturalistic Safety and Efficacy Outcomes in Patients With Moderate to Severe Plaque Psoriasis Transitiioned to Ustekinumab From Previous Methotrexate Therapy (TRANSIT)
Brief Summary: This purpose of this study is to assess the safety of ustekinumab in psoriasis patients who receive ustekinumab following an inadequate response to methotrexate therapy. The study will provide information for doctors on how to manage the transfer from methotrexate to the biologic agent ustekinumab. The study is designed to compare two methods of transferring patients from methotrexate to ustekinumab. The two methods being compared are discontinuation of methotrexate with immediate initiation of ustekinumab versus initiation of ustekinumab with overlap and gradual dose reduction of methotrexate over 4 weeks.


Options:
A: Inclusion Criteria:

* Have had a diagnosis of plaque-type psoriasis at least 6 months
* Plaque-type psoriasis covering at least 10% of total body surface areas
* Psoriasis area-and-severity index score of 12 or greater
* Considered by treating dermatologist to be a candidate for phototherapy or systemic treatment of psoriasis
* Women of childbearing potential and all men must agree to use adequate birth control measures
* Have no history of latent or active tuberculosis

Exclusion Criteria:

* Currently have nonplaque forms of psoriasis or drug-induced psoriasis
* Women who are pregnant or nursing, or men and women planning pregnancy while enrolled in the study
* Patients who have a history of chronic or recurrent infectious disease or who have or have had a serious infection requiring hospitalization or intravenous antibiotics within the previous 2 months
* Patients who have or ever have had a nontuberculous mycobacterial infection or opportunistic infection
* Patients known to be infected with human immunodeficiency virus, hepatitis B, or hepatitis C
* Patients who have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
* Have any known malignancy or have a history of malignancy within the previous 5 years (with the exception of basal cell carcinoma of the skin that has been treated with no evidence of recurrence)
B: Inclusion Criteria:

* Patients should have diagnosis of plaque-type psoriasis for at least 6 months prior to first administration of study agent (patients with concurrent psoriatic arthritis may be enrolled)
* Moderate-to-severe psoriasis scored as PASI \>= 10 at screening and at the time of first administration of ustekinumab
* Should currently receive (and have been receiving for at least 8 weeks directly prior to screening) systemic therapy with methotrexate at a dose of at least 10 mg/week but not exceeding 25 mg/week, with an inadequate response to this treatment (due to either efficacy or tolerability) and, in the judgment of the treating physician and patient, a treatment change is needed
* Women should take adequate birth control measures throughout the study and must agree to continue to use such birth control measures and not to become pregnant or plan to become pregnant for at least 15 weeks after the last dose of ustekinumab and for at least 6 months after the last dose of methotrexate
* Men must be using adequate birth control measures whilst receiving methotrexate and for 6 months after the last dose of methotrexate

Exclusion Criteria:

* Patients should not have non-plaque forms of psoriasis (eg, erythrodermic, guttate, or pustular)
* Should currently (and within 12 months) not receive ciclosporin, fumarates, PUVA, etanercept, efalizumab, infliximab, adalimumab or alefacept or other biologic or systemic therapy (and other therapy as indicated in the protocol)
* Women who are pregnant, breastfeeding, or planning pregnancy (both men and women) while enrolled in the study
* Have previously failed treatment with any therapeutic agent directly targeted at reducing IL-12 or IL-23, including, but not limited to, ustekinumab and ABT-874
* Active or latent Tuberculosis or other chronic or recurrent infectious disease
* Known history of lymphoproliferative disease
* Known malignancy or history of malignancy
C: Inclusion Criteria:

* Subject has provided informed consent
* Chronic plaque psoriasis for at least 6 months prior to Screening
* PASI (Psoriasis Area and Severity Index) \>=12 and BSA (body surface area) \>=10% and IGA (Investigator's Global Assessment) score 3 or greater on a 5-point scale
* Candidates for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
* Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug
* Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, up till 20 weeks after the last administration of study medication

Exclusion Criteria:

* Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced psoriasis
* Subject has any severe, progressive and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, gastrointestinal or neurological disease
* Subject has any significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
* Subject taking prohibited psoriatic medications
* Subject receiving any live vaccines within 8 weeks prior to the Baseline and subjects receiving Bacillus Calmette-Guerin (BCG) vaccination within 1 year prior to study drug administration
* Subject has previously received treatment with any anti-interleukin-17 (anti-IL-17) therapy or has been exposed to more than 1 biological response modifier (limited to anti-tumor necrosis factor (TNF) or IL-12/23) for psoriatic arthritis or psoriasis prior to the Baseline
* Subject has any current sign or symptom that may indicate an active infection (except for common cold)
D: Inclusion Criteria:

* Have had a diagnosis of plaque type psoriasis (psoriasis vulgaris);
* Have plaque-type psoriasis covering at least 10% of total body surface area
* Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis

Exclusion Criteria:

* Non-plaque or drug induced forms of psoriasis
* Cannot discontinue current systemic and/or topical therapies for the treatment of psoriasis
* Cannot discontinue phototherapy
* Any uncontrolled significant medical condition

Answer: B