Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Natrunix 400 mg

    Biological/Vaccine

    The active ingredient of Natrunix is an IgG4 monoclonal antibody indistinguishable from that naturally occurring in an IL-1a-immune healthy human. Natrunix is formulated as 200 mg/mL sterile liquid in a stabilizing isotonic formulation buffered to pH 7.0. The product is filled into a 2 mL glass pre-filled syringe suitable for subcutaneous injection. The drug product is formulated and buffered to a neutral body pH of 7.0.

  • Placebo

    Drug

    Placebo is a sterile liquid solution filled into a 2 mL glass pre-filled syringe, suitable for subcutaneous injection, containing the exact same buffer matrix used for Natrunix drug product

  • Methotrexate (MTX)

    Drug

    Methotrexate may be administered in pill form by mouth, as liquid by mouth, or by subcutaneous injection.Subjects enrolled in this study should be receiving a stable minimum weekly dose of 10mg. Weekly methotrexate should not exceed 25 mg/week.

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: 400mg Natrunix + MTX weeklyExperimental treatment 2 interventions
Group B: Placebo+ MTX weeklyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

ACR 20 response

The American College of Rheumatology (ACR) response criteria for rheumatoid arthritis (RA) are used to measure how effective study drug is in this study.

Time frame
at 14 weeks from baseline

Secondary outcomes

1

ACR 50 response rate

The American College of Rheumatology (ACR) response criteria for rheumatoid arthritis (RA) are used to measure how effective study drug is in this study.

Time frame
at 14 weeks from baseline
2

Mean change in number of swollen and tender joints based on 66/68-joint count

Subject's tender and swollen joint will be counted by investigators

Time frame
at 14 weeks from baseline
3

Mean change in NRS-pain score

Subjects will rate the pain score everyday between 7-10pm, where 0 is no pain and 10 is maximum pain

Time frame
at 14 weeks from baseline
4

ACR 70 response rate

The American College of Rheumatology (ACR) response criteria for rheumatoid arthritis (RA) are used to measure how effective study drug is in this study.

Time frame
at 2, 4, 8, 12 and 14 weeks from baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

XBiotech, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: