Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prospective, International, Multi-centre Study on ASAS Classification Criteria for SpA
Brief Summary: Background:

Existing criteria for AS/SpA such as mod. New York, ESSG, or Amor criteria for classification and/or diagnosis of spondyloarthritis have limitations when applied to early disease. Moreover, MRI is not part of any of the established criteria and the precise role of MRI in early axial disease has not been fully defined yet. Even less is known about sacroiliac (SI) changes in SpA patients with peripheral symptoms. A pilot study using data from 'paper patients' led to new candidate criteria for early spondyloarthritis. Subsequently, the members of the ASAS International Working Group decided to conduct a prospective multi-centre study to evaluate (validate) the new candidate criteria, and to assess their performance as diagnostic criteria.

Aims of the study:

1. To evaluate the new candidate criteria for axial SpA in a multi-centre setting.
2. To assess the potential role of the new candidate criteria to be used as diagnostic criteria. To accomplish this, inclusion of consecutive and undiagnosed patients is mandatory as are longer periods of follow-up .
3. To compare criteria encompassing the whole group of SpA such as ESSG and Amor criteria against criteria which are tailored to either predominant axial disease or predominant peripheral disease. To accomplish this, both patients with predominant axial disease (back pain) but also patient with predominant peripheral disease (arthritis/enthesitis) will be included.


Options:
A: Inclusion Criteria:

* Subjects with a clinical diagnosis of OA or RA and who are expected to require regular anti-inflammatory therapy for arthritis symptom management
* Subjects must be aged 60 years or older with or without a history of gastroduodenal (GD) ulceration; or be of any age 18 years or older and have had documented evidence of GD ulceration 90 days or more prior to the screening visit

Exclusion Criteria:

* Active GD ulceration or GD ulceration within 90 days of the screening visit.
* Concomitant use of low dose aspirin
* Previous MI, stroke or significant vascular disease.
B: 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.
C: 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
D: 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

Answer: D