Natrunix or Placebo in Combination With Methotrexate in Rheumatoid Arthritis
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ClinicalTrials.gov Identifier: NCT05363891 |
Recruitment Status :
Recruiting
First Posted : May 6, 2022
Last Update Posted : December 15, 2023
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Tracking Information | |||||||||
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First Submitted Date ICMJE | May 2, 2022 | ||||||||
First Posted Date ICMJE | May 6, 2022 | ||||||||
Last Update Posted Date | December 15, 2023 | ||||||||
Actual Study Start Date ICMJE | July 24, 2023 | ||||||||
Estimated Primary Completion Date | June 15, 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
ACR 20 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).
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Original Primary Outcome Measures ICMJE |
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).
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Natrunix or Placebo in Combination With Methotrexate in Rheumatoid Arthritis | ||||||||
Official Title ICMJE | Phase II, Double-blind, Placebo-Controlled, Randomized Trial Examining Natrunix in Combination With Methotrexate (+Folate) for the Treatment of Rheumatoid Arthritis | ||||||||
Brief Summary | Phase II, Double-Blind, Placebo-Controlled, Randomized Trial Examining Natrunix in Combination with MTX (+Folate) for the Treatment of Rheumatoid Arthritis | ||||||||
Detailed Description | Potential subjects will be consented and screened for study eligibility and the enrolled will be randomized in a 1:1:1 ratio to receive either: 200 mg Natrunix; 400mg Natrunix; or placebo. All subjects will enter the study on stable MTX dose. Subjects will receive once weekly injection of Natrunix or placebo in addition to MTX for 12 weeks. The study will conclude after 13 weeks. Study Duration is 17 weeks (4-week maximum screening + 12-week treatment period = 1-week follow-up. The primary objective is to determine the ACR 20 response rate in subjects receiving stable dose of MTX and after 12 weeks of treatment with either Natrunix or placebo. The study will also examine what impact the addition of Natrunix or placebo has on the scores of various rheumatological grading scales, including ACR 50, NRS-pain score, and 66/68-joint count, as well as safety. All subjects enrolled in the study will be taking concomitant methotrexate. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Arm 1- Natrunix 200mg with MTX(+Folate) Arm 2 - Natrunix 400mg with MTX(+Folate) Arm 3- Placebo with MTX(+Folate) Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Double-blind study Primary Purpose: Treatment
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Condition ICMJE | Rheumatoid Arthritis | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
210 | ||||||||
Original Estimated Enrollment ICMJE |
150 | ||||||||
Estimated Study Completion Date ICMJE | August 15, 2024 | ||||||||
Estimated Primary Completion Date | June 15, 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Patients may be included in the study if they meet all of the following criteria:
Exclusion Criteria: Patients with ANY of the following will be excluded from the study:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT05363891 | ||||||||
Other Study ID Numbers ICMJE | 2021-PT055 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Current Responsible Party | XBiotech, Inc. | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | XBiotech, Inc. | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | XBiotech, Inc. | ||||||||
Verification Date | December 2023 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |