Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Abbott
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Documented history of refractory asthma, as defined by the American Thoracic Society,31 defined as 1 major and at least 2 minor criteria
Actual or documented history of reversible airway obstruction
Baseline FEV1 of 40% - 80% of the predicted for height, age, and sex at Screening, as demonstrated 6 or more hours after a short-acting -agonist and/or 24 or more hours after a long-acting -agonist
History of at least 1 asthma exacerbation leading to oral, IV or IM corticosteroid or ER/Urgent Care Center visit or hospitalization within the past year prior to Screening. This asthma exacerbation should not have been within 30 days prior to Screening
Adequate cardiac, renal and hepatic function as determined by the principal investigator and demonstrated by Screening laboratory evaluations, questionnaires, and physical examination results that are within normal limits
Subjects must be able to self-inject study medication or have a designee or healthcare professional who can inject the study medication
You may not be if
Active lung diseases (e.g., bronchitis, chronic obstructive pulmonary disease \[COPD\], interstitial lung disease, pulmonary fibrosis) other than asthma
Current treatment for corticosteroid-resistant asthma (e.g., methotrexate \[MTX\], cyclosporine, gold salts, troleandomycin, immune globulin intravenous \[IGIV\], mycophenolate mofetil)
History of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma - in-situ of the cervix.
History of listeria, human immunodeficiency virus (HIV), chronic or active Hepatitis B, an immunodeficiency syndrome, central nervous system (CNS) demyelinating disease or active TB
Females who are pregnant or will not discontinue breast-feeding.
Subject with a history of clinically significant drug or alcohol abuse in the last year
Subjects with a poorly controlled medical condition.
Abnormal, clinically significant screening laboratory and other analyses (including ECG).
Subjects with any prior exposure to Tysabri® (natalizumab)
Prior treatment with any TNF antagonist, including adalimumab
Clareo Health | A Dose-Finding Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Adalimumab in Subjects With Refractory Asthma
