Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable Rheumatoid Arthritis Patients in Clinical Remission (ADMIRE)
Brief Summary: The purpose of this pilot study is to investigate the possibility of discontinuing adalimumab therapy in patients with rheumatoid arthritis who are in stable remission after treatment with adalimumab in combination with methotrexate.


Options:
A: 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
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:

* Diagnosis of rheumatoid arthritis.
* Currently receiving an optimal dose of oral Methotrexate (MTX)(at least 15 mg/week but no more than 25 mg/week) for the treatment of rheumatoid arthritis.
* Active rheumatoid arthritis at the time of screening.

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), other than MTX within 28 days before baseline.
* Concurrent treatment with more than 1 non-steroid anti-inflammatory drug (NSAID) at baseline.
D: Inclusion Criteria:

1. Subject has a minimum 1 year history/diagnosis of rheumatoid arthritis based on the 1987 American College of Rheumatology (ACR) Revised criteria for RA.
2. Subject must have active rheumatoid arthritis despite methotrexate (MTX) therapy of ≥10 mg/wk for at least 12 weeks. The MTX dose must be stable for at least 4 weeks immediately prior to screening.

Exclusion Criteria:

1. Subjects who used any of the following systemic treatments during the washout periods given below:

   1. Oral corticosteroid dose of prednisone \>7.5 mg/day (or equivalent) or a change in dose within 28 days of baseline.
   2. Treatment with more than 1 NSAID within 14 days at baseline.
   3. Methotrexate dose greater than 25 mg/week, or change in the dose of methotrexate within 28 days of baseline.
   4. Subjects will be allowed to continue the following non biologic DMARDs: sulfasalazine, hydroxychloroquine, and leflumomide. All other non-biologic DMARDs (including but not limited to gold, penicillamine, azathioprine, cyclophospamide), and biologic DMARDs must have been discontinued at least 2 months prior to Week 1.
   5. Any biologic B cell depleting agent (eg, rituximab) within 2 years of Week 1.
2. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
3. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.

Answer: B