Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Investigator Initiated, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Humira® (Adalimumab) For The Treatment of Interstitial Cystitis(IC)
Brief Summary: The purpose of this study is to evaluate an investigational treatment for interstitial cystitis. Interstitial cystitis is a chronic bladder disease that includes the following symptoms: Urinary frequency during the day,urinary frequency at night, urinary urgency and bladder discomfort relieved by voiding.

Presently, there is no cure for interstitial cystitis. The response to current treatments is poor. Patients with interstitial cystitis have a poorer quality of life. The cause of interstitial cystitis is unknown. This study is evaluating the drug Humira® (adalimumab) for improving the symptoms of patients with interstitial cystitis. Humira® is an injectable anti-inflammatory medication that has been available for use since December 31, 2002. Humira® has been FDA approved for the treatment of rheumatoid arthritis, psoriasis, ankylosing spondylitis, and Crohn's disease. These diseases have similar characteristics to interstitial cystitis. This study will evaluate an investigational use of Humira® for the treatment of interstitial cystitis.


Options:
A: Inclusion Criteria:

* Patients with interstitial cystitis/ painful bladder syndrome for more than 6 months with moderate to severe pain and a micturition frequency greater than 7 per day.
* Patients who have been on stable oral medicines for interstitial cystitis/ painful bladder syndrome for at least 3 months. Other therapies might need to be stopped.

Exclusion Criteria:

* Patients on certain recent treatments for interstitial cystitis/ painful bladder syndrome.
* Body mass index (BMI) of \>39 kg/m2.
* History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.
* Patients with peripheral neuropathy.
* Patients with Type I or type II diabetes mellitus who have an HbA1c \> 8.0%.
B: Inclusion Criteria:

* Women 18 years and older
* Women with IC/BPS who have a score of ≥ 6 on either index (problem or symptom index) of the O'Leary-Sant questionnaire who have selected bladder instillations as part of their IC/BPS treatment
* Suitability for follow-up

Exclusion Criteria:

* Contraindications and/or allergies to the ingredients used in the bladder instillations
* Diagnosis of idiopathic thrombocytopenic purpura
* Does not desire to undergo bladder instillation therapy or unwilling to undergo bladder instillation therapy on schedule mandated by study
* Have a known alternative diagnosis explaining bladder pain symptoms that would preclude the diagnosis of IC/BPS (e.g. radiation cystitis, active urinary tract infection with bacteria or fungus treated within last 2 weeks or diagnosed at index visit, bladder injury or trauma within the last 30 days)
* Inability to speak or read English
* Bladder instillation within the past 4 weeks
C: Inclusion Criteria:

* Participant has signed and dated the appropriate Informed Consent document.
* Female participant is ≥ 18 years of age.
* Currently using an approved method of birth control, or surgically sterile, or of non-child bearing age with no menstrual period for the past year.
* Participant has a clinical diagnosis of IC/PBS in the opinion of the investigator.
* Participant with IC/PBS has reported a bladder pain/discomfort score of 3 or greater on a 0-10 Likert scale over the previous four weeks. This bladder pain/discomfort criterion must be met at each of the two baseline screening visits as reported by the participant.
* Participant with IC/PBS has reported a symptom score of abnormal urinary frequency of 3 or greater on a 0-10 Likert scale over the previous four weeks. This frequency criterion must be met at each of the two baseline screening visits, as reported by the participant.
* Participant has had symptoms of discomfort or pain in the pelvic region for at least a three (3) month period within the last six (6) months.
* Current symptoms have been present for less than 3 years. If similar symptoms were present in the past, they must have been completely resolved for at least one year prior to onset of current symptoms.
* Participant has previously undergone at least one course of therapy (other than physical therapy) for her symptoms.
* Presence of tenderness/pain to palpation found by the physician in one of the pelvic floor musculature domains during the first baseline screening visit physical examination which are confirmed by the physical therapist at screening visit 2. Presence of tenderness/pain is defined as a mild, moderate or severe finding by the physician at visit 1 and physical therapist at visit 2. The pelvic floor musculature domains are defined as: anterior or posterior levator muscles, obturator internus muscles and urogenital diaphragm (bulbospongiosus, superficial transverse perinei, ischiocavernosus, central tendon/perineal body). The assessment of tenderness/pain at Visits 1 and 2 do not need to be identical in severity or location in order for the participant to be eligible.

Exclusion Criteria:

* Participant has relevant, painful scars on lower abdominal wall that, in the opinion of the study physician or physical therapist, is unlikely to respond to physical therapy without adjuvant therapy such as injection /needling.
* A positive urine culture (defined as \>100,000 CFU/ml) is exclusionary. A negative urine culture within 1 month of study enrollment is acceptable.
* Participant is unable to tolerate insertion of one or two vaginal examining fingers (e.g. vulvar allodynia), or one rectal examining finger.
* Participant had prior course of physical therapy that included manual therapy with connective tissue manipulation by physical therapist for same symptoms. Prior treatment by therapist with biofeedback, electrical stimulation, or pelvic floor exercises is not exclusionary.
* Participant has relevant neurologic disorder that affects bladder and/or neuromuscular function in the opinion of the investigator.
* Participant has active urethral or ureteral calculi, urethral diverticulum.
* Participant has a history of pelvic radiation therapy, tuberculous cystitis, bladder cancer, carcinoma in situ, or urethral cancer.
* Participant has/reports any severe debilitating or urgent concurrent medical condition.
* Participant has a potentially significant pelvic pathology or abnormalities on examination or prior imaging, including prolapse beyond the hymenal ring, pelvic mass, etc. that could cause or contribute to the clinical symptoms or require treatment.
* Participant is unlikely to be compliant due to unmanaged medical or psychological condition, including neurological, psychological or speech /language problems that will interfere with her ability to complete the study.
* Participant has an imminent change in residence or other social factors that could compromise compliance with the protocol.
* Pregnancy or refusal of medically approved/reliable birth control in women of child-bearing potential.
* Participant has pain, frequency, urgency symptoms present only during menses.
D: Inclusion Criteria:

* Males or females ≥18 and ≤ 65 years of age previously diagnosed with Interstitial Cystitis
* Currently have symptoms of urinary urgency, frequency or pain for more than 6 months
* Urinating at least 7 times a day or having some urgency or pain (measured on linear analog scales)
* Must be post-menopausal or surgically sterile or willing to use an adequate form of birth control
* Not pregnant or lactating
* Capable of voiding independently
* Willing to provide informed consent to participate

Exclusion Criteria:

* Have symptoms that are presently relieved on other medications for interstitial cystitis
* Have absence of nocturia
* Have symptoms that are relieved by antimicrobials or antibiotics.
* Have a body mass index (BMI) of \>39 kg/m2
* Have uncontrolled hypertension
* Have Type I or type 2 diabetes
* Have active Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) infection, or who are known carriers (Hepatitis B) at Screening
* Have a positive tuberculosis test at screening
* Have had a urinary tract infection for 6 weeks
* Have had bacterial cystitis in previous 3 months
* Have had previous exposure to Humira® (adalimumab)
* Have taken investigational medication within 30 days of screening
* Have any other condition/disease which, in the opinion of the investigator, could compromise subject safety or confound the interpretation of study results
* Are unable or unwilling to comply with protocol requirements

Answer: D