Study Description: The purpose of this study is to determine the safety and effectiveness (how well the drug works) of oral (given by mouth) bardoxolone methyl in people with World Health Organization (WHO) Group 1 classification of Pulmonary Arterial Hypertension (PAH) associated with connective tissue disease (CTD-PAH).The study plans to enroll approximately 130 participants who are between 18 and 75 years of age. Bardoxolone methyl is an investigational (experimental) drug that is being tested and is not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory agency in the United States or any other country. The purpose of this research study is to see how an investigational drug works to treat CTD-PAH. To test the effectiveness, we will evaluate how bardoxolone methyl affects your exercise ability and measures of clinical improvement. To evaluate safety, we will monitor vital signs, laboratory assessments, and ECGs, in addition to tracking any adverse events. .
Principal Investigator: James Gossage
Eligibility Criteria: Patients are eligible to participate in this protocol if they are: Men and women between 18 to75 of age and have pulmonary hypertension associated with connective tissue disease (CTD-PAH) Must be able to walk a distance of 150 meters Patients must be on no more than 2 pulmonary hypertension approved medications prior to enrollment
Compensation: Yes, subjects will be compensated.
Compensation Explanation: You will receive $50 USD for each completed in-clinic visit while participating in this study. You may also be reimbursed for any reasonable expenses related to the study (meal, Travel (bus/train/taxi fares)) incurred as a result of taking part in this study on production of a receipt. Your study doctor will provide you additional information on what travel expenses may be reimbursed. If you agree to wear the activity monitor while on the study, You will receive $25 for wearing the device from Day 1 to Week 1. You will receive $200 if you wear the device from Week 16 through Week 24. If you agree to the optional blood drug concentration sub-study blood collection, you will recieve a one-time payment of $100 for your time. If you are receiving compensation over $100.00 from participating in this study, you will be required to complete a W-9 form. If you are an AU employee, your compensation will be transmitted as part of your institutional compensation. This payment will be subject to Federal and Georgia state withholding taxes as well as FICA tax, these payments will be included in your payroll check and will reflect on the W-2 form at calendar year end. If you are not an AU employee and your total compensation from AU exceeds $600.00 in a calendar year, a 1099 will be issued to you and the IRS at the end of the year. If you agree to participate in this study, you and/or your insurance will not be billed for the tests and treatments that are being done only for research. However, you are still responsible for paying for the usual care you would normally receive for the treatment of your illness. You will be responsible for all co-pays, deductibles and denied claims.
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