Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-30 @ 9:20 AM
Study NCT ID:
NCT01990157
Status:
COMPLETED
Last Update Posted:
2017-02-28
First Post:
2013-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacodynamics and Efficacy Study of TAB08 in Patients With Rheumatoid Arthritis
Sponsor:
Theramab LLC
Organization:
Study Overview
Official Title:
Safety, Tolerability, Pharmacodynamics and Efficacy Study of TAB08 in Patients With Rheumatoid Arthritis in Which Methotrexate (MTX) Treatment is Not Effective
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
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:
None
Brief Summary:
This study is in two stages:
Stage 1 purpose is to assess safety, tolerability, and efficacy of multiple TAB08 doses in patients with active Rheumatoid Arthritis in which methotrexate (MTX) treatment is not enough effective.
Stage 2 purpose is to assess efficacy parameters (ACR criteria) of at least one selected TAB08 dose in extended patient population with active Rheumatoid Arthritis in which methotrexate (MTX) treatment with at least 10 mg/week is not enough effective.
Stage 1 purpose is to assess safety, tolerability, and efficacy of multiple TAB08 doses in patients with active Rheumatoid Arthritis in which methotrexate (MTX) treatment is not enough effective.
Stage 2 purpose is to assess efficacy parameters (ACR criteria) of at least one selected TAB08 dose in extended patient population with active Rheumatoid Arthritis in which methotrexate (MTX) treatment with at least 10 mg/week is not enough effective.
Detailed Description:
Stage 1 is designed as standard phase 1 study with one arm and sequential dose cohorts with ascending doses. Each patient in each dose cohort will be administered TAB08 several times. After last TAB08 administration each patient will undergo investigational-treatment-free follow-up period.
At Stage 2 at least one TAB08 dose, selected during Stage 1 will be studied during longer timeframe in extended patient population.
At Stage 2 at least one TAB08 dose, selected during Stage 1 will be studied during longer timeframe in extended patient population.
Study Oversight
Has Oversight DMC:
False
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?: