Safety, Tolerability, Pharmacodynamics and Efficacy Study of TAB08 in Patients With Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT01990157|
Recruitment Status : Completed
First Posted : November 21, 2013
Last Update Posted : February 28, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: TAB08||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety, Tolerability, Pharmacodynamics and Efficacy Study of TAB08 in Patients With Rheumatoid Arthritis in Which Methotrexate (MTX) Treatment is Not Effective|
|Actual Study Start Date :||November 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||February 2017|
Multiple TAB08 administrations as intravenous infusions.
Weekly intravenous administration in escalating doses.
Other Name: Theralizumab
- Incidence of dose-limiting toxicity in every dose cohort [ Time Frame: From study drug infusion (Day 1) untill week 2 (Day 15) for each patient ]
- Number of adverse events [ Time Frame: From study drug infusion (Day 1) untill the end of study stage 1 (Day 85) ]
- Pharmacokinetics parameters of TAB08 after single and multiple i.v. administrations [ Time Frame: From study drug infusion (Day 1) untill Week 4 (Day 29) ]
Following specific pharmacokinetics parameters will be used:
C max - maximal concentration, AUC(0-t) - area under the curve concentration-time until the last time point of concentration measurement, AUC(0-∞) - area under the curve concentration-time extrapolated to infinity, T1/2 - final elimination half-life, Lambda z - elimination rate constant, CL - clearance, Vss - volume of distribution in steady state, C trough - trough concentration after multiple administration.
- Proportion of patients with American College of Rheumatology (ACR) 20 (50, 70) response criteria after 4 weeks of TAB08 treatment [ Time Frame: From study drug infusion (Day 1) untill the Week 4 (Day 29) ]
- Proportion of patients with ACR20 (50, 70) response criteria after 4 weeks of TAB08 treatment at the end of study stage 1 [ Time Frame: From study drug infusion (Day 1) untill tenf of study stage 1 (Day 85) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01990157
|State Scientific and Research Rheumatology Institute|
|Moscow, Russian Federation, 115522|
|Clinical Emergency Hospital of Yaroslavl|
|Yaroslavl, Russian Federation, 150003|
|Study Director:||Daniil G Nemenov, M.D.||Theramab LLC|