Please select the eligibility criteria that correspond to the clinical trial below.
Title: Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA)
Brief Summary: This study involves Rheumatoid Arthritis patients in regular clinical setting who are already on etanercept treatment and are in remission or in a low disease activity (LDA) state, and is intended to identify parameters that can serve as guidance in clinical settings. This study will consider the clinical and radiographic course in subjects when etanercept treatment is tapered or discontinued, and analyze the subjects' experience of disease worsening and the predictive values of clinical parameters, serum biomarkers and imaging on the clinical and radiographic course in different treatment groups. The effect of re-treatment with etanercept at treatment failure will also be studied.


Options:
A: Inclusion Criteria:

* Diagnosis of early rheumatoid arthritis.
* Methotrexate (MTX) naive.
* Active early rheumatoid arthritis at the time of enrollment.

Exclusion Criteria:

* Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF) inhibitors, or other biologic agents.
* Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), within 4 weeks before baseline.
* Concurrent treatment with more than 1 non-steroidal anti-inflammatory drug (NSAID) at baseline.
B: Inclusion Criteria:

* Age ≥18 years.
* Diagnosis of RA as defined by the 1987-revised American College of Rheumatology (ACR)-classification and has positive rheumatoid factor (RF) test or erosion on X-ray of hands or feet.
* Currently treated with adalimumab and MTX (at least 10 mg/week; orally or subcutaneously).
* In remission as defined by disease activity score (DAS)28 \<2.6 for at least the past 3 months.
* Concomitant disease-modifying anti-rheumatic drug (DMARD) or oral corticosteroid therapy has been stable for at least 3 months at study entry.
* Female subject is either not of childbearing potential or is practicing a relevant method of birth control.
* Subject is judged to be in good general health.
* Subjects must be able and willing to provide written informed consent.
* Subjects must be able and willing to self-administer subcutaneous (SC) injections or have a qualified person available to administer SC injections.

Exclusion Criteria:

* Treatment with intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks.
* Oral prednisone or prednisone equivalent \> 10 mg/day at baseline.
* Joint surgery within the preceding two months.
* History of acute inflammatory joint disease other than RA.
* Treatment with any investigational drug within 30 days or 5 half lives, whichever is longer prior to study entry.
* Poorly controlled medical condition, which would put the subject at risk by participation in the study.
* History of clinically significant hematologic, renal or liver disease.
* Diagnosis of, or history suggestive of, central nervous system (CNS) demyelinating disease.
* History of cancer or lymphoproliferative disease other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma of the cervix.
* History of listeriosis, histoplasmosis, untreated tuberculosis (TB), persistent chronic infections, or recent active infections.
* Known immune deficiency or human immunodeficiency virus (HIV).
* Female who is pregnant or breast-feeding or considering becoming pregnant or breast feeding during the study.
C: Inclusion criteria:

* Subject has a current DAS28 equal to or less than 3.2.
* Subject is currently receiving treatment with etanercept, either 25 mg twice weekly or 50 mg once weekly, for a minimum of 14 months at baseline
* Subject is currently receiving oral, sc or intramuscular methotrexate once weekly, 7.5 mg/week to 25 mg/week and at a stable dose for a minimum of 4 months at baseline.

Exclusion Criteria:

* Subject has earlier had an attempt of discontinuing etanercept for reasons of remission or low disease activity state.
* Subject has received any disease-modifying anti-rheumatic drug, other than methotrexate, within one month before baseline.
* Subject has had a dose of prednisone (or equivalent) \>7.5 mg/day or has received intra-articular, intravenous, intramuscular, or subcutaneous corticosteroid within one month of baseline.
D: Inclusion Criteria:

- Those subjects in previous study RA0055 Period 1 who are in sustained LDA (defined as DAS28\[ESR\] ≤ 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1

Exclusion Criteria:

- Those subjects in previous study RA0055 Period 1 who are NOT in sustained LDA (defined as DAS28\[ESR\] ≤ 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1

Answer: C