Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Intra-Articular metHuIL-1ra (Anakinra) in Subjects With Osteoarthritis (OA) of the Knee
Brief Summary: The purpose of this study is to evaluate the clinical response in subjects with symptomatic OA of the knee following a single 50 mg anakinra, 150 mg anakinra or placebo intra-articular (IA) injection.


Options:
A: Inclusion Criteria:

Patients 18 years of age or older who have moderate to severely active axial spondyloarthritis.

Diagnosis made by:Chronic low back pain (duration \> 3 months, onset \< 50 years of age)plus 3 out of the 6 following criteria (including two of the following three criteria: inflammatory back pain, positive for HLA-B27 and positive MRI showing acute inflammatory lesions in spine or ISG)

* Inflammatory back pain1
* Good or very good response to NSAIDs
* One or more of the following extraspinal manifestations: uveitis, peripheral arthritis, enthesitis
* HLA-B27 positive
* Positive MRI showing acute inflammatory lesions in spine or ISG
* Positive family history for SpA Active disease is defined as a BASDAI score of equal or more than 4, back pain score (BASDAI question 2) of equal or more than 4 despite concurrent NSAID therapy, or intolerance to NSAIDs.

Other inclusion criteria include:

If on prednisone, equal or less than 7.5 mg per day; stable for 4 weeks prior to baseline.

An evaluation for latent tuberculosis infection will be performed using a Mendel Mantoux Test with 10TE (PPD), reading a chest x-ray, which should have been performed within the last 12 weeks before inclusion, and history of exposure to infected subjects. Patients who have evidence of latent TB infection should be given prophylaxis in accordance with local guidelines (Isoniazid 300 mg with adequate substitution of vitamin B6 for 9 months or 600 mg Rifampicine for 6 months). The prophylaxis will start 4 weeks before adalimumab is administered. After 2 weeks of prophylaxis blood tests (liver enzymes, creatinine and blood count) will be obtained. Patients with documented prophylaxis in the past need not to repeat this treatment.

Women of child bearing potential must have a negative pregnancy test at study baseline and use an adequate method of contraception (including 3 months after study completion). Sexual active men must use an accepted method of contraception including 3 months after study completion.

Able to self-administer injectable drug supplies or have a caregiver who will do so.

Able to store injectable test article at 2° to 8° C.

Exclusion Criteria:

Definite ankylosing spondylitis (according to modified New York criteria, sacroiliitis ³ grade 2 bilaterally or grade 3 to 4 unilaterally) History of active tuberculosis (TB), histoplasmosis or listeriosis. History of positive HIV status. Positive serology for hepatitis B or C indicating active infection, in case of hepatitis B also if indicating chronic infection History of malignancy other than carcinoma in situ of the cervix or adequately treated non-metastatic squamous or basal cell skin carcinoma.

Antibiotic treatment within 3 weeks prior to screening. Treatment with biologicals within the last 12 weeks If on DMARDs a washout period of at least 4 weeks is necessary. If Leflunomide was discontinued, it should be stopped at least 3 months or should be washed out within 4 weeks before study start.

History of uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months), ongoing congestive heart failure, and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.

Female subjects who are pregnant or breast-feeding. Previous diagnosis or signs of demyelinating diseases History of systemic lupus erythematosusReceipt of any live (attenuated) vaccines within 4 weeks before screening visit Laboratory exclusions are: hemoglobin level \< 8,5 mg/dl, white blood cell count \< 3.5 x109/l, platelet count \< 125 x 109 /l, creatinine level \> 175 µmol/liver enzymes or alkaline phosphatase \>2 times the upper limit of normal.

Participation in trials of other investigational medications within 30 days of entering the study Clinical examination showing significant abnormalities of clinical relevance History or current evidence of abuse of "hard" drugs (e.g. cocaine/heroine) or alcoholism
B: Inclusion Criteria: - Diagnosed with knee OA as determined by American College of Rheumatology (ACR) criteria - Pain defined by a level of greater than 30 mm on a 100 mm Visual Analogue Scale (VAS) - No evidence of active effusion or inflammatory flare, confirmed by investigator - Must exhibit radiographic evidence of tibio-femoral compartment knee OA within 12 months of screening - Stable doses of any non-prescribed supplements (e.g. glucosamine or chondroitin sulphate, shark cartilage, diacerhein, soya extract) for at least 2 months prior to screening - Unchanged use of physical therapy, biomechanical devices or orthotic support within at least 2 months of screening - Subjects on nonsteroidal anti-inflammatory drug (NSAID) therapy must discontinue NSAIDs 3 days prior to baseline (Day 1) - Before any study-specific procedure is performed, the appropriate written informed consent for participation in the study must be obtained Exclusion Criteria: - Malignancy within the previous 5 years, except for basal cell or in situ cancer - Significant hematologic disease - Active infection or history of recurrent or chronic infections - Known diagnosis of HIV, hepatitis B, or hepatitis C infection - Uncontrolled diabetes or cardiovascular disease and hypertension - Inflammatory arthropathy including secondary OA - Isolated OA of the patellofemoral joint (bi or tri-compartmental involvement are not exclusions) - End-stage ("bone-on-bone") OA (Kellgren Lawrence score of 4) - OA of the hip ipsilateral to the index knee - Total white cell count less than 2.0 x 109/L and/or platelet count less than 100 x 109/L observed within 1 month preceding screening - Prior IA injection of anakinra or experimental interleukin-1 (IL-1) inhibitor therapy - Concurrent treatment with subcutaneous (SC) anakinra - Concurrent or recent (less than or equal to 1 month) use of experimental therapy - Prior IA corticosteroid injection within 1 month of study - Prior viscosupplement therapy within 3 months of study - Contraindication(s) to IA injections - Subjects who are pregnant or breast-feeding, or plan to become pregnant during the study - Subject is not using adequate contraception - Known allergy to E coli-derived products - Unable to understand informed consent - Concerns regarding subject's compliance with the protocol procedures - Subject will not be available for follow-up assessment - Active substance abuse
C: Inclusion Criteria:

* Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
* Subject had a clinical diagnosis of psoriasis for at least 6 months, had moderate to severe plaque psoriasis.
* Subject was able and willing to self-administer sc injections or had available qualified person(s) to administer sc injections

Exclusion Criteria:

* Subject had previously received anti-TNF therapy.
* Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy
* Subject cannot avoid excessive sun exposure
* Subject is taking or requires oral or injectable corticosteroids
* 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:

* Patients who have had ulcerative colitis of at least 3 months' duration at screening
* Patients who have ulcerative colitis confirmed by the biopsy taken at screening
* Patients must have active colitis confirmed during the screening sigmoidoscopy
* Patients must have active disease.

Exclusion Criteria:

* Patients must not be likely to require surgical removal of all or part of the colon within 12 weeks of beginning the study
* Patients must not require, or required within the 2 months prior to beginning the study, surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage

Answer: B