Study Complete
Sponsor ID
20130258

Long-term Safety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis

Sponsor ID
20130258
Clinicaltrials.gov ID
NCT02114931
EUCTIS ID
N/A
EudraCT ID
2013-004654-13

Study Details

The purpose of this open-label study is to evaluate the long-term safety and efficacy of ABP 501 in adults with moderate to severe rheumatoid arthritis (RA).

Additional Study Details

Phase
Phase 3
Product
ABP 501
Type
Interventional
Masking
None (Open Label)
Enrollment
467
Additional Study Details

Protocol Summary

Primary Outcome Measures

Subject incidence of adverse events and serious adverse events

Timeframe: Up to week 72

Clinically significant changes in laboratory values and vital signs

Timeframe: Up to week 72

Incidence of anti-drug antibodies

Timeframe: Up to week 72

Secondary Outcome Measures

ACR 20 (20% improvement in American College of Rheumatology (ACR) core set measurements at all measured time points)

Timeframe: Up to week 70

Disease Activity Score (DAS) 28-CRP at all timepoints

Timeframe: Up to week 70

Locations

Location
Status
Contact Us
Location
Research Site
Budapest, Budapest, Hungary, 1036
Status
Recruiting
Location
Research Site
Carrollton, TX, United States, 75007
Status
Recruiting
Location
Research Site
Covina, CA, United States, 91723
Status
Recruiting
Location
Research Site
Dallas, TX, United States, 75231
Status
Recruiting
Location
Research Site
Duncansville, PA, United States, 16635
Status
Recruiting
Location
Research Site
Huntsville, AL, United States, 35801
Status
Recruiting
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