Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Psoriatic Arthritis
Brief Summary: This study was to provide 24 - 52 week efficacy, safety and tolerability data to support the registration of the secukinumab (AIN457) prefilled syringe (PFS) for subcutaneous self administration in subjects with active PsA despite current or previous NSAID, DMARD and/or anti-TNFα therapy. An additional 4 years of long-term efficacy and safety data were collected during the post Week 52 period of the study.


Options:
A: Inclusion Criteria:

* The subject must meet ALL of the criteria listed below for entry into the study:
* Subject must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
* Subject aged 18 years or more, of either sex and any race
* Diagnosis of Psoriatic Arthritis with peripheral polyarticular involvement. Patients will have at least one of the following:

  * Distal Interphalangeal Joints (DIP) involvement
  * polyarticular arthritis, absence of rheumatoid nodules and presence of psoriasis
  * arthritis mutilans
  * asymmetric peripheral arthritis
* Negative rheumatoid factor
* The disease should have been diagnosed at least 3 months prior to screening.
* Active disease at the time of screening and prior to receiving the baseline study medication(s) as defined by:

  * 5 or more swollen joints and
  * 5 or more tender joints
  * and one out of the following three categories:

    * Erythrocyte Sedimentation Rate (ESR) \>= 28 mm/h
    * C-reactive protein (CRP) \>= 15 mg/l
    * Morning stiffness \>= 45 min
* Subjects must confirm that they are practicing adequate contraception: Female subjects of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active during the study) must agree to use a medically accepted method of contraception or be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 6 months after stopping the medication. Acceptable methods of contraception include condoms (male and female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptive, and surgical sterilization (e.g., hysterectomy or tubal ligation).
* Female subjects of childbearing potential must have a negative pregnancy test at Screening.
* Subjects must be eligible for anti-tumor necrosis factor (TNF) treatment according to applicable local guidelines. For all patients chest X-ray and skin test results must be available at baseline.
* If using Nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids other than i.v., i.m. or i.a., the patient must be on a stable dose for four weeks prior screening (maximum dose up to 10mg/day of prednisone or its oral equivalent).
* The screening laboratory tests must beet the following criteria:

  * Hemoglobin \>= 10 g/dl providing the low hemoglobin level is not due to other diseases than anemia of chronic inflammation.
  * white blood cell (WBC) \>= 3500 / μl
  * Neutrophils \>= 1500 / μl
  * Platelets \>= 100 000/ μl
  * Aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, and gamma-glutamyltransferase \<= 1.5 x upper limit of normal
  * Total bilirubin \<= 1 x upper limit of normal
  * Serum creatinine \<= 1.5 mg/dl
* Patient must be able to adhere to the study visit schedule and other protocol requirements and must have given informed consent prior to any screening procedures.

Exclusion Criteria:

* The subject will be excluded from entry into the study if ANY of the criteria listed below are met:
* Subject is a female who is pregnant, intends to become pregnant during the study (or within 6 months after study completion), or nursing.
* Patients with other inflammatory diseases that might interfere with the evaluation of the psoriatic arthritis.
* Previous treatment with Infliximab.
* Subjects who have previously received MTX or have not discontinued their other DMARD therapy (i.e., sulfasalazine, hydroxychloroquine, leflunomide).
* Patients with fibromyalgia syndrome.
* Use of cyclosporine or tacrolimus within 4 weeks prior to screening. Use of IM, IV, or IA corticosteroids within 4 weeks prior to screening.
* Treatment with any investigational drug within 3 months prior to screening.
* Previous treatment with a monoclonal antibody or a fusion protein.
* A history of known allergy to murine proteins.
* History of infected joint prosthesis within the previous 5 years.
* Chronic infections.
* History of active tuberculosis requiring treatment within previous 3 years or history of opportunistic infections within 2 months, uncontrolled active infection or documented HIV infection. Also excluded are patients with evidence of latent tuberculosis and patients with old tuberculosis without documented adequate therapy, if they will not be treated according to local tuberculosis (TB) guidelines.
* Subject has any clinically significant deviation from normal in the physical examination, chest X-ray, or electrocardiogram (ECG) that, in the investigator's judgment, may interfere with the study evaluation or affect subject safety.
* Current signs or symptoms of other severe uncontrolled diseases, which in the investigators opinion would put the patient at an unacceptable risk.
* History of lymphoproliferative disease, any current malignancies or history of malignancy within 5 years other than successfully treated basal cell carcinoma or squamous cell carcinoma of the skin.
* Subject is part of the staff or a family member of the staff personnel directly involved with this study.
* History of drug abuse.
* Subjects who are participating in any other clinical study.
B: Inclusion Criteria:

* Subject is \>18 years of age at the time of consent.
* Subject has a confirmed diagnosis of plaque psoriasis by clinical judgment.
* Subject is able to read and complete questionnaires.
* Subjects planning to undergo radiographic evaluation, should not have any contraindications to MRI.

Exclusion Criteria:

* None.
C: Inclusion Criteria:Patients eligible for inclusion in this study have to fulfill all of the following criteria:

* Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)
* Rheumatoid factor and anti-CCP antibodies negative at screening
* Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or documented history of plaque psoriasis
* Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization with inadequate control of symptoms or at least one dose if stopped due to intolerance to NSAIDs
* Subjects taking corticosteroids must be on a stable dose of ≤10 mg/day prednisone or equivalent for at least 2 weeks before randomization and should remain on a stable dose up to Week 24
* Subjects taking MTX (≤ 25 mg/week) are allowed to continue their medication if the dose is stable for at least 4 weeks before randomization and should remain on a stable dose up to Week 52.

Exclusion Criteria:Patients fulfilling any of the following criteria are not eligible for inclusion in this study:

* Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
* Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
* Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor
* Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at randomization. The following wash out periods need to be observed:
* Oral or topical retinoids 4 weeks
* Photochemotherapy (e.g. PUVA) 4 weeks
* Phototherapy (UVA or UVB) 2 weeks
* Topical skin treatments (except in face, scalp and genital area during screening, only corticosteroids with mild to moderate potency) 2 weeks
* Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα, investigational or approved
* Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)
D: Inclusion Criteria:

* Have had psoriatic arthritis (PsA) for at least 6 months prior to the first administration of study agent
* Have a diagnosis of active PSA as defined by 5 or more swollen joints and 5 or more tender joints at Screening and at Baseline and C-reactive protein \>=0.6 milligram per deciliter (mg/dL) at Screening
* Have active plaque psoriasis or a documented history of plaque psoriasis
* Have active PsA despite current or previous disease-modifying antirheumatic drugs (DMARD) and/or nonsteroidal anti-inflammatory drug (NSAID) therapy. DMARD therapy is defined as taking a DMARD for at least 3 months, or evidence of DMARD intolerance. NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of NSAID intolerance

Exclusion Criteria:

* Have other inflammatory diseases that might confound the evaluations of benefit of Golimumab therapy, including but not limited to rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease
* Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 4 months after receiving the last administration of study agent
* Have used any biologic agents that are targeted for reducing tumor necrosis factors (TNF) alpha, including but not limited to Infliximab, Etanercept, Adalimumab, Golimumab, and Certolizumab Pegol
* Have ever used cytotoxic drugs, including Chlorambucil, Cyclophosphamide, Nitrogen mustard, or other Alkylating agents

Answer: C