Natrunix + Methotrexate for Rheumatoid Arthritis

Recruiting in Palo Alto (17 mi)

+25 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: XBiotech, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?Phase II, Double-Blind, Placebo-Controlled, Randomized Trial Examining Natrunix in Combination with MTX (+Folate) for the Treatment of Rheumatoid Arthritis

Eligibility Criteria

This trial is for adults with Rheumatoid Arthritis who've been on a stable Methotrexate (MTX) dose for at least 12 weeks and are willing to continue it. They should have had the condition for over 3 months, experience significant joint swelling and pain, and can't have had bad reactions to similar treatments before.

Inclusion Criteria

I have been diagnosed with rheumatoid arthritis for at least 3 months.

I am willing and able to follow a methotrexate (with folate) treatment plan without previous intolerance.

I have been on a stable dose of methotrexate with folate for at least 12 weeks.

+4 more

Participant Groups

The study tests Natrunix combined with MTX against a placebo (a treatment with no active drug), both alongside MTX therapy. It's a Phase II trial where participants don't know if they're getting Natrunix or the placebo.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Natrunix 400mg with MTX(+Folate)Experimental Treatment1 Intervention

Natrunix 400mg, subcutaneous injection in combination with Methotrexate (+Folate).This arm will enroll 70 subjects.

Group II: Natrunix 200mg with MTX(+Folate)Experimental Treatment1 Intervention

Natrunix 200mg, subcutaneous injection in combination with Methotrexate (+Folate).This arm will enroll 70 subjects.

Group III: Placebo with MTX(+Folate)Placebo Group1 Intervention

Placebo in combination with Methotrexate (+Folate).This arm will enroll 70 subjects.