Natrunix will be assessed in combination with MTX (+folate) to determine the ACR 50 response rate. A total study population of 150 subjects with 1:1 randomization (75 subjects receiving Natrunix with MTX (+folate) and 75 receiving placebo with MTX (+folate)).~The study duration is 17 weeks (4-week maximum screening + 12-week treatment period + 1-week follow up).~Patients will undergo a preliminary assessment for study eligibility. Patients who meet the eligibility criteria will be screened and be required to provide an informed consent to acknowledge understanding and accept enrollment in the clinical study. Subjects enrolled will be randomized in a 1:1 ratio to receive either test article or placebo + MTX (+folate). Four weeks are allotted to complete all screening procedures. During the screening period, certain treatments will be washed out (discontinued), as applicable, according to eligibility requirements.~Clinical assessments, collection of blood samples for Natrunix pK determination or other analysis will be performed at specified clinic visits. Natrunix + MTX + folate OR placebo + MTX + folate will be administered weekly for 12 weeks. After 13 weeks, the study will conclude. All data must be entered into the database in a timely manner, including data from the last visit. The primary endpoint for the study will be comparing the ACR 50 response between the subjects receiving Natrunix versus those receiving placebo.
Phase II, Double-Blind, Placebo-Controlled, Randomized Trial Examining Natrunix in Combination with MTX (+Folate) for the Treatment of Rheumatoid Arthritis