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Natrunix + Methotrexate for Rheumatoid Arthritis

Phase 2
Recruiting
Research Sponsored by XBiotech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of RA for greater than or equal to 3 months.
Subjects must be willing comply with MTX (+folate) regimen and have no prior MTX (+folate) intolerance.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 weeks from baseline
Awards & highlights
All Individual Drugs Already Approved

Summary

This trial tests a drug combo for easing RA pain and disability. Patients are randomly assigned placebo/drug, doctor/patient unaware.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects of Natrunix aren't listed here, common ones in arthritis medications include stomach issues, liver problems, infections due to lowered immunity, allergic reactions, and injection site discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with rheumatoid arthritis for at least 3 months.
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I am willing and able to follow a methotrexate (with folate) treatment plan without previous intolerance.
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I have been on a stable dose of methotrexate with folate for at least 12 weeks.
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I have at least 6 swollen and 6 tender joints with a high disease activity score.
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I have stopped any biologic or JAK inhibitor treatments for their full half-life period.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 weeks from baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 weeks from baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
ACR 20 response rate at 12 weeks.
Secondary study objectives
ACR 50 response rate at 12 weeks.
Mean change in NRS-pain at 12 weeks

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

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.

Find a Location

Who is running the clinical trial?

XBiotech, Inc.Lead Sponsor
7 Previous Clinical Trials
494 Total Patients Enrolled
2 Trials studying Rheumatoid Arthritis
258 Patients Enrolled for Rheumatoid Arthritis
~93 spots leftby Nov 2025
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