Natrunix in Combination With Methotrexate for Rheumatoid Arthritis Treatment
ConditionRheumatoid Arthritis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorXBiotech, Inc.
About this trial
Approximately 108 subjects will be randomized in 2 arms in 2:1 ratio to receive weekly subcutaneous injections of either 400mg Natrunix + MTX weekly or placebo + MTX weekly for 14 weeks. At the week 14 visit subjects in both arms will undergo a safety follow up visit OR begin receiving biweekly subcutaneous injections of 400mg Natrunix for 14 weeks as part of an Open Label Extension (OLE).
The study will last for a maximum of 33 weeks, including: a screening period of up to 4 weeks, a 14-week double-blinded treatment phase followed by a 14-week open label extension phase and one-week follow-up.
Eligibility criteria
Qualifiers
Weight > 40 kg
Diagnosis of moderate to severe RA according to 2010 ACR/EULAR classification criteria.
Patients must be methotrexate-inadequate responders.
Meets the following minimum disease activity criteria at screening: ≥6 swollen joints (based on DAS28) and ≥6 tender joints (based on DAS28) and DAS-ESR (Erythrocyte Sedimentation Rate) > 3.2.
Disqualifiers
History of treatment with Natrunix for any reason.
Any active, chronic, or recurrent infections. (e.g., ongoing bacterial, viral, or fungal infection).
Comorbid severe psychiatric illness and/or complicated social situations that would limit compliance with study requirements.
Patients with a positive result of TB test (QuantiFERON-TB Gold (QFT) at screening unless the patients can present a documentation of completion of TB treatment course by the local Health Department and a clear chest x-ray at enrollment.
Trial design
Treatments tested in this trial
- Natrunix 400 mg
- Placebo
- Methotrexate (MTX)
Treatment groups
108 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov