Status:
UNKNOWN
Natrunix Versus Methotrexate in Rheumatoid Arthritis
Lead Sponsor:
XBiotech, Inc.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Phase II Double-Blinded, Placebo-Controlled Randomized Study Examining the Safety and Efficacy of Natrunix versus MTX (+folate) for the Treatment of Rheumatoid Arthritis
Detailed Description
The ACR50 response rate will be determined for Natrunix treatment in comparison with MTX (+folate). There will be a total study population of 150 subjects with 1:1 randomization (75 subjects receiving...
Eligibility Criteria
Inclusion
- Subjects must be willing comply with MTX regimen (+folate) and have no prior MTX (+folate) intolerance.
- Subject has no prior history of MTX (+folate) failure for the treatment of RA.
- Diagnosis of RA for greater than or equal to 3 months.
- Meets the following minimum disease activity criteria at screening and baseline: ≥6 swollen joints (based on DAS28) and ≥6 tender joints (based on DAS28) and DAS-ESR \> 3.2.
- Normal CBC, hepatic and bone marrow function according to the site's institutional guidelines.
- Male or female, at least 18 years, willing to provide informed consent; able to attend all clinic visits and comply with study-related procedures; and able to understand and complete study-related questionnaires.
Exclusion
- History of treatment with Natrunix for any reason.
- Uncontrolled intercurrent illness (e.g., ongoing infection, psychiatric illness/social situations that would limit compliance with study requirements).
- Subject has a prior history of MTX (+folate) failure for the treatment of RA.
- Subjects received MTX (+folate) for any reason for the previous 6 weeks prior to randomization.
- Patients must not have received any biological therapy within 8 weeks prior to randomization.
- No treatment with protein tyrosine kinase (PTK) inhibitors within 4 weeks of randomization.
- Investigational therapy administered within a time interval less than at least 5 half-lives of the investigational agent, whichever was longer, prior to the first scheduled day of dosing in this study.
- Pregnant or breastfeeding subjects.
- Patients with alcoholism or other substance abuse.
- Uncontrolled heart disease, including NYHA Class III or IV congestive heart failure, ventricular arrhythmias, uncontrolled blood pressure (defined as ≥ 160/100 mm Hg), or unstable angina.
- Any other concomitant disease, disorder, or condition that could interfere with patient's safety, ability to participate, or interpretation of study results.
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 15 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05363917
Start Date
June 15 2022
End Date
February 15 2023
Last Update
May 6 2022
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