Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-29 @ 7:26 PM
Study NCT ID:
NCT02005757
Status:
UNKNOWN
Last Update Posted:
2015-06-26
First Post:
2013-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Mizoribine in Active Rheumatoid (AMOLED)
Sponsor:
Chong Kun Dang Pharmaceutical
Organization:
Study Overview
Official Title:
Open Label, Multicenter, Randomized Study to Assess the Efficacy and Safety of Mizoribine in Active Rheumatoid Arthritis Patients Unsuccessfully Treated With Disease-modifying Antirheumatic Drug
Status:
UNKNOWN
Status Verified Date:
2015-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMOLED
Brief Summary:
The purpose of this study is to access the efficacy and safety of Mizoribine 150mg qid and 50mg tid in active rheumatoid arthritis patients unsuccessfully treated with disease-modifying antirheumatic drug.
Detailed Description:
1. EULAR Response after 24weeks of treatment
2. EULAR Response after 12weeks of treatment
3. DAS28 value change
4. KHAQ-20 value change
2. EULAR Response after 12weeks of treatment
3. DAS28 value change
4. KHAQ-20 value change
Study Oversight
Has Oversight DMC:
True
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?: