Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596772
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
A Study to Compare Efficacy Pharmacokinetics Safety and Immunogenicity of MB04 proposed Etanercept Biosimilar to Enbrel EU-sourced in Rheumatoid Arthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Randomized Double-blind Parallel-group Study to Compare the Efficacy Safety Pharmacokinetics and Immunogenicity of MB04 and EU-sourced Enbrel in Patients with Moderate to Severe Rheumatoid Arthritis
Status:
RECRUITING
Status Verified Date:
2024-09
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:
A study to compare efficacy pharmacokinetics safety and immunogenicity of MB04 proposed etanercept biosimilar to Enbrel EU-sourced in rheumatoid arthritis
Detailed Description:
The study will randomize approximately 458 patients aged between 18 and 75 years with active Rheumatoid Arthritis despite methotrexate therapy
All patients shall receive methotrexate for 12 weeks and on a stable dose 10 to 25 mgweek for 8 weeks prior to randomization and folic acid 5 mgweek from 4 weeks prior to screening until the end of the treatment period Week 36
Screening evaluations will be completed within 28 days prior to randomization There will be 2 periods in the study Main Treatment period and Transition period
During the Main Treatment Period eligible patients will be randomized at a 11 ratio to administer a 50 mg weekly dose of MB04 or EU- sourced Enbrel subcutaneously SC using an Interactive Response System IRT After completing Week 24 assessment patients will continue to receive the study treatment up to Week 36 Those patients who were originally assigned to EU-sourced Enbrel will be randomized at a 11 ratio to receive either MB04 or EU-sourced Enbrel SC while patients originally assigned to MB04 will continue with the same treatment until Week 36
After treatment discontinuation patients will undergo a Safety follow-up period for 4 weeks up to week 40
All patients shall receive methotrexate for 12 weeks and on a stable dose 10 to 25 mgweek for 8 weeks prior to randomization and folic acid 5 mgweek from 4 weeks prior to screening until the end of the treatment period Week 36
Screening evaluations will be completed within 28 days prior to randomization There will be 2 periods in the study Main Treatment period and Transition period
During the Main Treatment Period eligible patients will be randomized at a 11 ratio to administer a 50 mg weekly dose of MB04 or EU- sourced Enbrel subcutaneously SC using an Interactive Response System IRT After completing Week 24 assessment patients will continue to receive the study treatment up to Week 36 Those patients who were originally assigned to EU-sourced Enbrel will be randomized at a 11 ratio to receive either MB04 or EU-sourced Enbrel SC while patients originally assigned to MB04 will continue with the same treatment until Week 36
After treatment discontinuation patients will undergo a Safety follow-up period for 4 weeks up to week 40
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