Study to Assess if ABP798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Rituximab
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|ClinicalTrials.gov Identifier: NCT02792699|
Recruitment Status : Active, not recruiting
First Posted : June 7, 2016
Last Update Posted : June 12, 2018
This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe RA.
This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.
|Condition or disease||Intervention/treatment||Phase|
|Arthritis, Rheumatoid||Drug: ABP 798 Drug: Rituximab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||311 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis|
|Actual Study Start Date :||May 17, 2016|
|Estimated Primary Completion Date :||October 8, 2018|
|Estimated Study Completion Date :||October 8, 2018|
Experimental: ABP 798
Concentrate for solution, ABP 798 IV infusion x 2 at baseline and repeat at week 24.
Drug: ABP 798
Active Comparator: Rituximab (US)
Concentrate for solution, Rituxan IV infusion x 2 at baseline and repeat at week 24.
Drug: ABP 798
Active Comparator: Rituximab (EU)
Concentrate for solution, MabThera IV infusion x 2 at baseline and repeat at week 24.
- Area under the serum concentration-time curve (AUCinf) [ Time Frame: Day 15 ]Area under the serum concentration-time curve from time 0 extrapolated to infinity (AUCinf) following second infusion of the first dose
- Maximum serum concentration (Cmax) [ Time Frame: Day 15 ]Cmax following second infusion of the first dose
- ACR [American College of Rheumatology] improvement in core set measurements [ Time Frame: Week 24 ]
- Disease Activity Score 28-CRP [ Time Frame: Week 24 ]
- Subject incidence of adverse events and serious adverse events [ Time Frame: Weeks 24 and 48 ]
- Incidence of anti-drug antibodies [ Time Frame: Weeks 24 and 48 ]
- Pharmacodynamics (PD) endpoints will include the percent of subjects with complete depletion in CD19+ cell count [ Time Frame: Days 1 to 3 ]
- AUC from time 0 on day 1 prior to the first infusion of the first dose to day 14 (AUC 0-14 day) [ Time Frame: Day 1 to day 14 ]
- AUC from time 0 on day 1 prior to the first infusion of the first dose to week 12 (AUC 0-12 wk) [ Time Frame: Day 1 to Week 12 ]
- Cmax [ Time Frame: Day 1 ]Cmax following the first infusion of the first dose
- Clinical significant changes in laboratory values [ Time Frame: Weeks 24 and 48 ]
- Clinical significant changes in vital signs [ Time Frame: Weeks 24 and 48 ]
- to demonstrate PK similarity between rituximab (US) and rituximab (EU) as [ Time Frame: Day 15 ]
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): NCT02792699
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