Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis
Brief Summary: The purpose of the study is to assess the safety and clinical efficacy of adalimumab in subjects with active ankylosing spondylitis


Options:
A: Inclusion Criteria:

Include newly referred patients if:

* Onset of symptoms (back pain/arthritis/enthesitis) \< 45 years
* Undiagnosed disease with the following symptoms:

  * chronic back pain (duration of back pain more than 3 months)
  * and/or peripheral arthritis (asymmetric arthritis/predominantly of the lower limbs)
  * and/or enthesitis
  * and/or dactylitis

Exclusion Criteria:

* No symptoms such as specified in inclusion criteria: back pain, arthritis, enthesitis
* Definite diagnosis
B: Inclusion Criteria:

* Subjects must be \>= 18 years of age
* meet Modified NY Criteria definition of ankylosing spondylitis (AS)
* have diagnosis of active AS based on protocol specified criteria
* inadequate response or intolerance to \>= 1 nonsteroidal antiinflammatory drug (NSAID)
* be able and willing to learn to self-administer subcutaneous (SC) injections

Exclusion Criteria:

* Active tuberculosis, listeriosis,or hepatitis B, or any history of hepatitis C
* History of demyelinating disease, multiple sclerosis, cancer, or lymphoproliferative disease
* Previous anti-tumor necrosis factor therapy
* Treatment with disease-modifying antirheumatic drugs (DMARDs - other than methotrexate, hydroxychloroquine, and sulfasalazine)
* Treatment with intra-articular corticosteroid joint injections within 4 weeks of study dosing
* Biologic or investigational therapy within 6 weeks of study dosing
* Treatment with intravenous (IV) antibiotics within 30 days of study dosing
* Treatment with oral antibiotics within 14 days of study dosing
C: Inclusion Criteria:

* Subject was age 18 or older and in relatively good health (Investigator discretion) with a recent stable medical history.
* Subject met the definition of AS based on the Modified New York Criteria.
* Subject had an inadequate response to or intolerance to one or more NSAIDs as defined by the Investigator

Exclusion Criteria:

* Subject had previously received anti-TNF therapy.
* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Female subject who is pregnant or breast-feeding or considering becoming pregnant
D: Inclusion Criteria: - Subjects completing 24 weeks of study drug in protocol 16.0037 qualify to enroll into this study Other patients to meet the following criteria:

* Negative pregnancy test
* Subjects agree to use appropriate contraception throughout study
* Should be able to self-inject study drug or have someone who can do so
* Capable of understanding protocol and willing to provide written informed consent

Exclusion Criteria:

* Any change in NSAID or prednisone dose within 2 weeks of baseline
* Any change in hydroxychloroquine, sulfasalazine, or MTX dose within 4 weeks of baseline
* Use of DMARDs other than those mentioned above, within 4 weeks of enrollment
* Previous receipt of ani-TNF agents, other than etanercept
* Receipt of any other investigational drug within 30 days of baseline
* Grade 3 or 4 adverse event attributed to etanercept which recurred when etanercept was resumed
* Abnormality in chemistry or hematology profiles or significant concurrent medical events.

Answer: C