Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Infliximab
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.
Protocol Summary
Response difference measured by 20% improvement in ACR core set measurements (ACR20) at week 22
Timeframe: Week 22
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