Rheumatoid ArthritisPhase 2NCT05363917
Natrunix Versus Methotrexate in Rheumatoid Arthritis
A Phase 2 study of Rheumatoid Arthritis, run by XBiotech, Inc..
Trial summary
Phase II Double-Blinded, Placebo-Controlled Randomized Study Examining the Safety and Efficacy of Natrunix versus MTX (+folate) for the Treatment of Rheumatoid Arthritis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2022to 15 Feb 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be willing comply with MTX regimen (+folate) and have no prior MTX (+folate) intolerance.
- Subject has no prior history of MTX (+folate) failure for the treatment of RA.
- Diagnosis of RA for greater than or equal to 3 months.
- Meets the following minimum disease activity criteria at screening and baseline: ≥6 swollen joints (based on DAS28) and ≥6 tender joints (based on DAS28) and DAS-ESR > 3.2.
- Normal CBC, hepatic and bone marrow function according to the site's institutional guidelines.
- Male or female, at least 18 years, willing to provide informed consent; able to attend all clinic visits and comply with study-related procedures; and able to understand and complete study-related questionnaires.
Who cannot join
- History of treatment with Natrunix for any reason.
- Uncontrolled intercurrent illness (e.g., ongoing infection, psychiatric illness/social situations that would limit compliance with study requirements).
- Subject has a prior history of MTX (+folate) failure for the treatment of RA.
- Subjects received MTX (+folate) for any reason for the previous 6 weeks prior to randomization.
- Patients must not have received any biological therapy within 8 weeks prior to randomization.
- No treatment with protein tyrosine kinase (PTK) inhibitors within 4 weeks of randomization.
Show all 11Show fewer
- Investigational therapy administered within a time interval less than at least 5 half-lives of the investigational agent, whichever was longer, prior to the first scheduled day of dosing in this study.
- Pregnant or breastfeeding subjects.
- Patients with alcoholism or other substance abuse.
- Uncontrolled heart disease, including NYHA Class III or IV congestive heart failure, ventricular arrhythmias, uncontrolled blood pressure (defined as ≥ 160/100 mm Hg), or unstable angina.
- Any other concomitant disease, disorder, or condition that could interfere with patient's safety, ability to participate, or interpretation of study results.
About this study
Official title: Phase II Double-Blinded, Placebo-Controlled Randomized Study Examining the Safety and Efficacy of Natrunix Versus Methotrexate (+Folate) for the Treatment of Rheumatoid Arthritis
Phase II Double-Blinded, Placebo-Controlled Randomized Study Examining the Safety and Efficacy of Natrunix versus MTX (+folate) for the Treatment of Rheumatoid Arthritis
Read the detailed description
The ACR50 response rate will be determined for Natrunix treatment in comparison with MTX (+folate). There will be a total study population of 150 subjects with 1:1 randomization (75 subjects receiving Natrunix + MTX placebo (+folate) and 75 receiving Natrunix placebo + MTX (+folate)).
Patients will undergo a preliminary assessment for study eligibility. Patients who meet the eligibility criteria will be screened and be required to provide an informed consent to acknowledge understanding and accept enrollment in the clinical study. Subjects enrolled will be randomized in a 1:1 ratio to receive either test article (Natrunix) + MTX placebo OR Natrunix placebo + MTX (+folate). Four weeks are allotted to complete all screening procedures. During the screening period, certain treatments will be washed out (discontinued), as applicable, according to eligibility requirements.
Clinical assessments and collection of blood samples for Natrunix pK determination or other analysis will be performed at specified clinic visits. Natrunix + MTX placebo (+folate) OR Natrunix placebo + MTX (+folate) will be administered weekly for 12 weeks. After 13 weeks, the study will conclude. All data must be entered into the database in a timely manner, including data from the last visit.
Patients will receive the following treatments every week: 400 mg Natrunix or Natrunix placebo injected subcutaneously once a week, followed by MTX placebo or MTX taken orally once a week respectively and a minimum of 1 mg folic acid taken orally every day or 5 mg of folinic acid taken orally once a week.
A patient should start on a reduced dose of 7.5 mg of MTX or MTX placebo at visit 1. On day 5 (5 days after the first dose), the patient laboratory findings are checked and if there are no clinically significant findings, the dose of MTX or MTX placebo may be increased up to 15 mg once weekly and maintained throughout the study. The dose of MTX may range from 7.5-15 mg once weekly based on discretion of the Principal Investigator.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Natrunix with MTX placebo (+folate), Natrunix placebo with MTX (+folate)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natrunix with MTX placebo (+folate)Drug
True Human IgG4 monoclonal antibody that neutralizes Interleukin-1α
Natrunix placebo with MTX (+folate)Drug
Natrunix placebo with MTX (+folate)
| Study group | Role | What they receive |
|---|---|---|
| Natrunix with MTX placebo (+Folate) | Experimental | Natrunix 400mg, subcutaneous injection with oral MTX placebo (+Folate). This arm will enroll 100 subjects. Receives: Drug: Natrunix with MTX placebo (+folate) |
| Natrunix Placebo with MTX(+Folate) | Active comparator | Natrunix Placebo, subcutaneous injection with oral MTX(+Folate). This arm will enroll 50 subjects. Receives: Drug: Natrunix placebo with MTX (+folate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR 50 response rate at 12 weeks.
The ACR is a measure used in clinical practice and clinical trial to assess medication efficacy in patients with RA, by notating improvements in swelling and tenderness in designated joints, as well as improvements in at least 3 out of 5 other categories. The other categories assessed are patient global assessment of disease activity, physician global assessment of disease activity, patient reported pain scale, disability/functionality questionnaire response, and acute phase reactant levels (CRP and ESR).
Measured: At 12 weeks from baseline
Secondary outcomes (2)
ACR 20 response rate at 12 weeks.
Measured: At 12 weeks from baseline
Mean change in NRS-pain at 12 weeks.
Numerical rating scale (NRS) is a validated measure used to assess chronic and acute pain using a 10 point rating scale. The rating for no pain is "0" and "worst possible pain" is 10.
Measured: At 12 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start15 Jun 2022 (estimated)
- Primary completion15 Dec 2022 (estimated)
- Study completion15 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1: Natrunix with MTX placebo (+folate) Arm 2: Natrunix placebo with MTX (+folate)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XBiotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363917
- Sponsor's protocol ID
- 2022-PT059
- Status last verified
- May 2022
- First submitted
- 2 May 2022
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Double-Blinded, Placebo-Controlled Randomized Study Examining the Safety and Efficacy of Natrunix Versus Methotrexate (+Folate) for the Treatment of Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05363917
- Acronym / sponsor ID
- 2022-PT059
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- XBiotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2022 (estimated)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 15 Feb 2023 (estimated)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II Double-Blinded, Placebo-Controlled Randomized Study Examining the Safety and Efficacy of Natrunix versus MTX (+folate) for the Treatment of Rheumatoid Arthritis
Detailed description
The ACR50 response rate will be determined for Natrunix treatment in comparison with MTX (+folate). There will be a total study population of 150 subjects with 1:1 randomization (75 subjects receiving Natrunix + MTX placebo (+folate) and 75 receiving Natrunix placebo + MTX (+folate)).
Patients will undergo a preliminary assessment for study eligibility. Patients who meet the eligibility criteria will be screened and be required to provide an informed consent to acknowledge understanding and accept enrollment in the clinical study. Subjects enrolled will be randomized in a 1:1 ratio to receive either test article (Natrunix) + MTX placebo OR Natrunix placebo + MTX (+folate). Four weeks are allotted to complete all screening procedures. During the screening period, certain treatments will be washed out (discontinued), as applicable, according to eligibility requirements.
Clinical assessments and collection of blood samples for Natrunix pK determination or other analysis will be performed at specified clinic visits. Natrunix + MTX placebo (+folate) OR Natrunix placebo + MTX (+folate) will be administered weekly for 12 weeks. After 13 weeks, the study will conclude. All data must be entered into the database in a timely manner, including data from the last visit.
Patients will receive the following treatments every week: 400 mg Natrunix or Natrunix placebo injected subcutaneously once a week, followed by MTX placebo or MTX taken orally once a week respectively and a minimum of 1 mg folic acid taken orally every day or 5 mg of folinic acid taken orally once a week.
A patient should start on a reduced dose of 7.5 mg of MTX or MTX placebo at visit 1. On day 5 (5 days after the first dose), the patient laboratory findings are checked and if there are no clinically significant findings, the dose of MTX or MTX placebo may be increased up to 15 mg once weekly and maintained throughout the study. The dose of MTX may range from 7.5-15 mg once weekly based on discretion of the Principal Investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Arm 1: Natrunix with MTX placebo (+folate) Arm 2: Natrunix placebo with MTX (+folate)
| Arm | Type | Receives |
|---|---|---|
| Natrunix with MTX placebo (+Folate) | Experimental | Drug: Natrunix with MTX placebo (+folate)Natrunix 400mg, subcutaneous injection with oral MTX placebo (+Folate). This arm will enroll 100 subjects. |
| Natrunix Placebo with MTX(+Folate) | Active comparator | Drug: Natrunix placebo with MTX (+folate)Natrunix Placebo, subcutaneous injection with oral MTX(+Folate). This arm will enroll 50 subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must be willing comply with MTX regimen (+folate) and have no prior MTX (+folate) intolerance.
- Subject has no prior history of MTX (+folate) failure for the treatment of RA.
- Diagnosis of RA for greater than or equal to 3 months.
- Meets the following minimum disease activity criteria at screening and baseline: ≥6 swollen joints (based on DAS28) and ≥6 tender joints (based on DAS28) and DAS-ESR > 3.2.
- Normal CBC, hepatic and bone marrow function according to the site's institutional guidelines.
Key exclusion criteria (11 listed)
- History of treatment with Natrunix for any reason.
- Uncontrolled intercurrent illness (e.g., ongoing infection, psychiatric illness/social situations that would limit compliance with study requirements).
- Subject has a prior history of MTX (+folate) failure for the treatment of RA.
- Subjects received MTX (+folate) for any reason for the previous 6 weeks prior to randomization.
- Patients must not have received any biological therapy within 8 weeks prior to randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natrunix with MTX placebo (+folate)True Human IgG4 monoclonal antibody that neutralizes Interleukin-1α | Drug | Natrunix with MTX placebo (+Folate) |
| Natrunix placebo with MTX (+folate)Natrunix placebo with MTX (+folate) | Drug | Natrunix Placebo with MTX(+Folate) |
Primary outcome
ACR 50 response rate at 12 weeks.
Time frame: At 12 weeks from baseline
The ACR is a measure used in clinical practice and clinical trial to assess medication efficacy in patients with RA, by notating improvements in swelling and tenderness in designated joints, as well as improvements in at least 3 out of 5 other categories. The other categories assessed are patient global assessment of disease activity, physician global assessment of disease activity, patient reported pain scale, disability/functionality questionnaire response, and acute phase reactant levels (CRP and ESR).
2 secondary outcomes
ACR 20 response rate at 12 weeks.
Time frame: At 12 weeks from baseline
Mean change in NRS-pain at 12 weeks.
Time frame: At 12 weeks from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
Related trials for Rheumatoid Arthritis
Recruiting
Effect of Anti-inflammatory Diet in Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Rheumatoid Arthritis, run by XBiotech, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACR 50 response rate at 12 weeks. (time frame: At 12 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.