Study Complete
Sponsor ID
20140111

Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Infliximab

Sponsor ID
20140111
Clinicaltrials.gov ID
NCT02937701
EUCTIS ID
N/A
EudraCT ID
2014-004704-29

Study Details

The main purpose of the study was to compare rheumatoid arthritis symptom improvement in participants who were given

ABP 710 to those who were given infliximab, 22 weeks after starting treatment.

Additional Study Details

Phase
Phase 3
Product
ABP 710
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
558
Additional Study Details

Protocol Summary

Primary Outcome Measures

Response difference measured by 20% improvement in ACR core set measurements (ACR20) at week 22

Timeframe: Week 22

Secondary Outcome Measures

Response difference measured by 20% improvement in ACR core set measurements (ACR20) at week 2

Timeframe: Week 2

Response difference measured by 20% improvement in ACR core set measurements (ACR20) at week 6

Timeframe: Week 6

Response difference measured by 20% improvement in ACR core set measurements (ACR20) at week 14

Timeframe: Week 14

Response difference measured by 20% improvement in ACR core set measurements (ACR20) at week 30

Timeframe: Week 30

Response difference measured by 20% improvement in ACR core set measurements (ACR20) at week 34

Timeframe: Week 34

Response difference measured by 20% improvement in ACR core set measurements (ACR20) at week 38

Timeframe: Week 38

Response difference measured by 20% improvement in ACR core set measurements (ACR20) week 46

Timeframe: Week 46

Response difference measured by 20% improvement in ACR core set measurements (ACR20) at week 50

Timeframe: Week 50

Response difference measured by 50% improvement in ACR core set measurements (ACR50) at week 2

Timeframe: Week 2

Response difference measured by 50% improvement in ACR core set measurements (ACR50) at week 6

Timeframe: Week 6

Response difference measured by 50% improvement in ACR core set measurements (ACR50) at week 14

Timeframe: Week 14

Response difference measured by 50% improvement in ACR core set measurements (ACR50) at week 22

Timeframe: Week 22

Response difference measured by 50% improvement in ACR core set measurements (ACR50) at week 30

Timeframe: Week 30

Response difference measured by 50% improvement in ACR core set measurements (ACR50) at week 34

Timeframe: Week 34

Response difference measured by 50% improvement in ACR core set measurements (ACR50) at week 38

Timeframe: Week 38

Response difference measured by 50% improvement in ACR core set measurements (ACR50) at week 46

Timeframe: Week 46

Response difference measured by 50% improvement in ACR core set measurements (ACR50) at week 50

Timeframe: Week 50

Response difference measured by 70% improvement in ACR core set measurements (ACR70) at week 2

Timeframe: Week 2

Response difference measured by 70% improvement in ACR core set measurements (ACR70) at week 6

Timeframe: Week 6

Response difference measured by 70% improvement in ACR core set measurements (ACR70) at week 14

Timeframe: Week 14

Response difference measured by 70% improvement in ACR core set measurements (ACR70) at week 22

Timeframe: Week 22

Response difference measured by 70% improvement in ACR core set measurements (ACR70) at week 30

Timeframe: Week 30

Response difference measured by 70% improvement in ACR core set measurements (ACR70) at week 34

Timeframe: Week 34

Response difference measured by 70% improvement in ACR core set measurements (ACR70) at week 38

Timeframe: Week 38

Response difference measured by 70% improvement in ACR core set measurements (ACR70) at week 46

Timeframe: Week 46

Response difference measured by 70% improvement in ACR core set measurements (ACR70) at week 50

Timeframe: Week 50

Change in disease activity measured by the disease activity score in 28 joints - C-reactive protein (DAS28-CRP) at week 2

Timeframe: Week 2

Change in disease activity measured by the disease activity score in 28 joints - C-reactive protein (DAS28-CRP) at week 6

Timeframe: Week 6

Change in disease activity measured by the disease activity score in 28 joints - C-reactive protein (DAS28-CRP) at week 14

Timeframe: Week 14

Change in disease activity measured by the disease activity score in 28 joints - C-reactive protein (DAS28-CRP) at week 22

Timeframe: Week 22

Change in disease activity measured by the disease activity score in 28 joints - C-reactive protein (DAS28-CRP) at week 30

Timeframe: Week 30

Change in disease activity measured by the disease activity score in 28 joints - C-reactive protein (DAS28-CRP) at week 34

Timeframe: Week 34

Change in disease activity measured by the disease activity score in 28 joints - C-reactive protein (DAS28-CRP) week 38

Timeframe: Week 38

Change in disease activity measured by the disease activity score in 28 joints - C-reactive protein (DAS28-CRP) at week 46

Timeframe: Week 46

Change in disease activity measured by the disease activity score in 28 joints - C-reactive protein (DAS28-CRP) at week 50

Timeframe: Week 50

Treatment-emergent adverse events, serious adverse events, and adverse events of special interest

Timeframe: Baseline through Week 50

Clinically significant changes in laboratory values and vital signs

Timeframe: Baseline through Week 50

Incidence of antidrug antibodies at baseline

Timeframe: Baseline

Incidence of antidrug antibodies at week 2

Timeframe: Week 2

Incidence of antidrug antibodies at week 6

Timeframe: Week 6

Incidence of antidrug antibodies at week 14

Timeframe: Week 14

Incidence of antidrug antibodies at week 22

Timeframe: Week 22

Incidence of antidrug antibodies at week 30

Timeframe: Week 30

Incidence of antidrug antibodies at week 34

Timeframe: Week 34

Incidence of antidrug antibodies at week 38

Timeframe: Week 38

Incidence of antidrug antibodies week 50

Timeframe: Week 50

Study Documents

Study Synopsis
Available Language(s): English
Plain Language Summary of Results
Available Language(s): English, German, Polish, Spanish, Bulgarian, Czech, Romanian, Hungarian

Locations

Location
Status
Contact Us
Location
Research Site
Lexington, KY, United States, 40504
Status
Recruiting
Location
Research Site
Upland, CA, United States, 91786
Status
Recruiting
Location
Research Site
Aventura, FL, United States, 33180
Status
Recruiting
Location
Research Site
Carrollton, TX, United States, 75007-1601
Status
Recruiting
Location
Research Site
Charleston, SC, United States, 29406-9333
Status
Recruiting
Location
Research Site
Houston, TX, United States, 77429-5890
Status
Recruiting
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