Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-27 @ 9:24 PM
Study NCT ID:
NCT01410695
Status:
TERMINATED
Last Update Posted:
2018-12-17
First Post:
2011-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Masitinib in Refractory Active Rheumatoid Arthritis
Sponsor:
AB Science
Organization:
Study Overview
Official Title:
A 24-week With Possible Extension, Prospective, Multicenter, Randomised, Double-blind, Controlled, 3-parallel Groups, Phase 2b/3 Study to Compare Efficacy and Safety of Masitinib at 3 and 6 mg/kg/Day to Methotrexate, With a Randomisation 1:1:1, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including at Least One Biologic Drug if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Biologic Drugs
Status:
TERMINATED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision based on portfolio prioritization
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective is to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: