Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590090
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Natrunix in Combination with Methotrexate for Rheumatoid Arthritis Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase II Double-Blind Placebo-Controlled Randomized Trial Examining Natrunix in Combination with Methotrexate for the Treatment of Rheumatoid Arthritis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Approximately 108 subjects will be randomized in 2 arms in 21 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
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
Detailed Description:
Number of Planned Subjects Approximately 108 subjects within 2 arms randomized 21 400 mg Natrunix MTX weekly n72 or placebo MTX weekly arms n36
Study Duration 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
Study Design Subjects will be randomized into the study in a 21 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
Subjects will undergo a preliminary assessment for study eligibility Subjects who meet pre-screening requirements may then provide informed consent to acknowledge understanding of and accept enrollment into the clinical study Subjects enrolled in the study will be taking concomitant methotrexate have a diagnosis of moderate to severe RA according to 2010 ACREULAR classification criteria and have 6 swollen joints based on DAS28 6 tender joints based on DAS28 and DAS-ESR 32
Study Duration 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
Study Design Subjects will be randomized into the study in a 21 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
Subjects will undergo a preliminary assessment for study eligibility Subjects who meet pre-screening requirements may then provide informed consent to acknowledge understanding of and accept enrollment into the clinical study Subjects enrolled in the study will be taking concomitant methotrexate have a diagnosis of moderate to severe RA according to 2010 ACREULAR classification criteria and have 6 swollen joints based on DAS28 6 tender joints based on DAS28 and DAS-ESR 32
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None