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Natrunix 200mg with MTX(+Folate) 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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 weeks from baseline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

ACR 20 response rate at 12 weeks.

Secondary outcome measures

ACR 50 response rate at 12 weeks.

Mean change in NRS-pain at 12 weeks

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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

XBiotech, Inc.Lead Sponsor

5 Previous Clinical Trials

319 Total Patients Enrolled

1 Trials studying Rheumatoid Arthritis

150 Patients Enrolled for Rheumatoid Arthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is recruitment taking place for this research endeavor?

"Affirmative. According to records hosted on clinicaltrials.gov, this medical trial commenced on July 24th 2023 and was recently updated on December 8th 2023. It is currently enrolling 210 patients across 3 locations."

Answered by AI

Are there any vacancies in this research initiative for potential participants?

"This research study is currently seeking enrolment, and information on the clinicaltrials.gov website reflects that it was initially posted in July of 2023 and revised most recently in December of the same year."

Answered by AI

Is Natrunix 200mg with MTX(+Folate) considered a safe medication for patient use?

"Natrunix 200mg with MTX(+Folate) is classed as a Phase 2 trial, thus the safety rating from Power was assigned a moderate score of 2 due to limited efficacy data."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Natrunix or Placebo in Combination With Methotrexate in Rheumatoid Arthritis

2023. "Natrunix or Placebo in Combination With Methotrexate in Rheumatoid Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05363891.

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