Study Complete
Sponsor ID
20130108

Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab

Sponsor ID
20130108
Clinicaltrials.gov ID
NCT02792699
EUCTIS ID
N/A
EudraCT ID
2013-005543-90

Study Details

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 also assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.

Additional Study Details

Phase
Phase 3
Product
ABP 798
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
311
Additional Study Details

Protocol Summary

Primary Outcome Measures

Area under the serum concentration-time curve (AUCinf)

Timeframe: Day 15

Maximum serum concentration (Cmax)

Timeframe: Day 15

Secondary Outcome Measures

ACR [American College of Rheumatology] improvement in core set measurements

Timeframe: Week 24

Disease Activity Score 28-CRP

Timeframe: Week 24

Subject incidence of adverse events and serious adverse events

Timeframe: Weeks 24 and 48

Incidence of anti-drug antibodies

Timeframe: Weeks 24 and 48

Pharmacodynamics (PD) endpoints will include the percent of subjects with complete depletion in CD19+ cell count

Timeframe: 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)

Timeframe: 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)

Timeframe: Day 1 to Week 12

Cmax

Timeframe: Day 1

Clinical significant changes in laboratory values

Timeframe: Weeks 24 and 48

Clinical significant changes in vital signs

Timeframe: Weeks 24 and 48

to demonstrate PK similarity between rituximab (US) and rituximab (EU) as

Timeframe: Day 15

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Berlin, BERLIN, Germany, 10117
Status
Recruiting
Location
Research Site
Białystok, PODLASKIE, Poland, 15-297
Status
Recruiting
Location
Research Site
Lublin, Lubelskie, Poland, 20-582
Status
Recruiting
Location
Research Site
Poznań, Wielkopolskie, Poland, 60-218
Status
Recruiting
Location
Research Site
Budapest, PEST, Hungary, 1083
Status
Recruiting
Location
Research Site
Magdeburg, SACHSEN-ANHALT, Germany, 39120
Status
Recruiting
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