Trial Outcomes & Findings for A Study of Japanese Rheumatoid Arthritis Participants (NCT NCT01253291)
NCT ID: NCT01253291
Last Updated: 2019-03-01
Results Overview
Included are the number of participants who experienced SAEs and treatment-emergent other non-SAEs. A summary of SAEs and other non-SAEs, regardless of causality, is located in the Reported Adverse Events (AEs) module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
Baseline up to 72 weeks
Results posted on
2019-03-01
Participant Flow
Participants who completed NCT01253226 \[Study H9B-JE-BCDK (BCDK)\] were enrolled into open-label study NCT01253291 \[H9B-JE-BCDL (BCDL\]).
Participant milestones
| Measure |
Placebo/LY2127399 120 mg Q4W
Participants who previously received placebo in Study BCDK were assigned to receive 120 milligrams (mg) of LY2127399 administered subcutaneously (SC) once every 4 weeks (Q4W) for 48 weeks.
|
LY2127399 30 mg Q4W/120 mg Q4W
Participants who previously received 30 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 60 mg Q4W/120 mg Q4W
Participants who previously received 60 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q4W/120 mg Q4W
Participants who previously received 120 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q2W/120 mg Q4W
Participants who previously received 120 mg of LY2127399 every 2 weeks (Q2W) in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
4
|
5
|
5
|
|
Overall Study
Received Study Drug During BCDL
|
6
|
6
|
4
|
5
|
5
|
|
Overall Study
COMPLETED
|
2
|
4
|
4
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo/LY2127399 120 mg Q4W
Participants who previously received placebo in Study BCDK were assigned to receive 120 milligrams (mg) of LY2127399 administered subcutaneously (SC) once every 4 weeks (Q4W) for 48 weeks.
|
LY2127399 30 mg Q4W/120 mg Q4W
Participants who previously received 30 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 60 mg Q4W/120 mg Q4W
Participants who previously received 60 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q4W/120 mg Q4W
Participants who previously received 120 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q2W/120 mg Q4W
Participants who previously received 120 mg of LY2127399 every 2 weeks (Q2W) in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
0
|
2
|
Baseline Characteristics
A Study of Japanese Rheumatoid Arthritis Participants
Baseline characteristics by cohort
| Measure |
Placebo/LY2127399 120 mg Q4W
n=6 Participants
Participants who previously received placebo in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 30 mg Q4W/120 mg Q4W
n=6 Participants
Participants who previously received 30 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 60 mg Q4W/120 mg Q4W
n=4 Participants
Participants who previously received 60 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q4W/120 mg Q4W
n=5 Participants
Participants who previously received 120 mg of LY2127399 Q4W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q2W/120 mg Q4W
n=5 Participants
Participants who previously received 120 mg of LY2127399 Q2W in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 17.4 • n=5 Participants
|
66.5 years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
47.8 years
STANDARD_DEVIATION 16.9 • n=5 Participants
|
53.8 years
STANDARD_DEVIATION 14.1 • n=4 Participants
|
55.8 years
STANDARD_DEVIATION 8.6 • n=21 Participants
|
56.4 years
STANDARD_DEVIATION 13.5 • n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
|
Region of Enrollment
Japan
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 72 weeksPopulation: All enrolled participants who received at least 1 dose of study drug during BCDL.
Included are the number of participants who experienced SAEs and treatment-emergent other non-SAEs. A summary of SAEs and other non-SAEs, regardless of causality, is located in the Reported Adverse Events (AEs) module.
Outcome measures
| Measure |
Placebo/LY2127399 120 mg Q4W
n=6 Participants
Participants who previously received placebo in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 30 mg Q4W/120 mg Q4W
n=6 Participants
Participants who previously received 30 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 60 mg Q4W/120 mg Q4W
n=4 Participants
Participants who previously received 60 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q4W/120 mg Q4W
n=5 Participants
Participants who previously received 120 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q2W/120 mg Q4W
n=5 Participants
Participants who previously received 120 mg Q2W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Treatment Emergent Other Non-Serious AEs
|
5 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12, 24, 36, 52, and 72Population: All enrolled participants with an anti-CCP antibody assessment at 1 or more of the specified timepoints.
Anti-CCP is a disease related peripheral blood biomarker used to assess disease progression of rheumatoid arthritis (RA). A reduction in anti-CCP values indicates an improvement.
Outcome measures
| Measure |
Placebo/LY2127399 120 mg Q4W
n=9 Participants
Participants who previously received placebo in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 30 mg Q4W/120 mg Q4W
Participants who previously received 30 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 60 mg Q4W/120 mg Q4W
Participants who previously received 60 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q4W/120 mg Q4W
Participants who previously received 120 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q2W/120 mg Q4W
Participants who previously received 120 mg Q2W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody
Anti-CCP Week 12
|
19.9 Percent Change of Anti-CCP
Standard Deviation 54.4
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody
Anti-CCP Week 24
|
8.5 Percent Change of Anti-CCP
Standard Deviation 43.8
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody
Anti-CCP Week 36
|
-1.2 Percent Change of Anti-CCP
Standard Deviation 19.7
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody
Anti-CCP Week 52
|
17.4 Percent Change of Anti-CCP
Standard Deviation 50.7
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody
Anti-CCP Week 72
|
-4.4 Percent Change of Anti-CCP
Standard Deviation 31.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12, 24, 36, 52, and 72Population: All enrolled participants who had 1 or more RF assessment at 1 or more of the specified timepoints.
RF is a disease-related, peripheral blood biomarker used to assess disease progression of RA. A reduction in RF values indicate an improvement in RA symptoms.
Outcome measures
| Measure |
Placebo/LY2127399 120 mg Q4W
n=20 Participants
Participants who previously received placebo in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 30 mg Q4W/120 mg Q4W
Participants who previously received 30 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 60 mg Q4W/120 mg Q4W
Participants who previously received 60 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q4W/120 mg Q4W
Participants who previously received 120 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q2W/120 mg Q4W
Participants who previously received 120 mg Q2W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Rheumatoid Factor (RF)
RF Week 12
|
-2.0 Percent Change of RF
Standard Deviation 67.0
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Rheumatoid Factor (RF)
RF Week 24
|
-9.7 Percent Change of RF
Standard Deviation 47.8
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Rheumatoid Factor (RF)
RF Week 36
|
-7.9 Percent Change of RF
Standard Deviation 57.3
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Rheumatoid Factor (RF)
RF Week 52
|
-2.3 Percent Change of RF
Standard Deviation 63.7
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Rheumatoid Factor (RF)
RF Week 72
|
25.3 Percent Change of RF
Standard Deviation 98.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12, 24, 36, 52, and 72Population: All enrolled participants with IgG, IgM or IgA assessment at 1 or more of the specified timepoints.
IgG, IgM and IgA are disease related peripheral blood biomarkers used to assess disease progression of RA. A reduction in Ig values indicate an improvement in RA symptoms.
Outcome measures
| Measure |
Placebo/LY2127399 120 mg Q4W
n=26 Participants
Participants who previously received placebo in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 30 mg Q4W/120 mg Q4W
Participants who previously received 30 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 60 mg Q4W/120 mg Q4W
Participants who previously received 60 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q4W/120 mg Q4W
Participants who previously received 120 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q2W/120 mg Q4W
Participants who previously received 120 mg Q2W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA]
IgG Week 12
|
-4.4 Percent Change of Ig
Standard Deviation 13.0
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA]
IgG Week 24
|
-3.8 Percent Change of Ig
Standard Deviation 11.0
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA]
IgG Week 36
|
-5.1 Percent Change of Ig
Standard Deviation 12.1
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA]
IgG Week 52
|
-5.1 Percent Change of Ig
Standard Deviation 14.2
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA]
IgG Week 72
|
-2.0 Percent Change of Ig
Standard Deviation 14.5
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA]
IgM Week 12
|
-7.7 Percent Change of Ig
Standard Deviation 11.6
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA]
IgM Week 24
|
-9.3 Percent Change of Ig
Standard Deviation 12.4
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA]
IgM Week 36
|
-11.6 Percent Change of Ig
Standard Deviation 12.5
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA]
IgM Week 52
|
-12.4 Percent Change of Ig
Standard Deviation 15.8
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA]
IgM Week 72
|
-9.0 Percent Change of Ig
Standard Deviation 24.9
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA]
IgA Week 12
|
-5.0 Percent Change of Ig
Standard Deviation 12.9
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA]
IgA Week 24
|
-6.0 Percent Change of Ig
Standard Deviation 14.5
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA]
IgA Week 36
|
-7.2 Percent Change of Ig
Standard Deviation 15.4
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA]
IgA Week 52
|
-5.8 Percent Change of Ig
Standard Deviation 13.2
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA]
IgA Week 72
|
-2.6 Percent Change of Ig
Standard Deviation 20.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12, 24, 36, 52, and 72Population: All enrolled participants with CD20+ B-Cell assessment at 1 or more of the specified timepoints.
CD20+ B-cells are a disease-related peripheral blood biomarker used to assess disease progression of RA. A reduction in CD20+ B-cell values indicate an improvement in RA symptoms.
Outcome measures
| Measure |
Placebo/LY2127399 120 mg Q4W
n=26 Participants
Participants who previously received placebo in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 30 mg Q4W/120 mg Q4W
Participants who previously received 30 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 60 mg Q4W/120 mg Q4W
Participants who previously received 60 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q4W/120 mg Q4W
Participants who previously received 120 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q2W/120 mg Q4W
Participants who previously received 120 mg Q2W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in CD20+ B-cell Count
CD20+ B Week 12
|
3.8 Percent Change of cells
Standard Deviation 43.0
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in CD20+ B-cell Count
CD20+ B Week 24
|
-17.3 Percent Change of cells
Standard Deviation 31.9
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in CD20+ B-cell Count
CD20+ B Week 36
|
-20.8 Percent Change of cells
Standard Deviation 25.6
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in CD20+ B-cell Count
CD20+ B Week 52
|
-32.0 Percent Change of cells
Standard Deviation 18.7
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in CD20+ B-cell Count
CD20+ B Week 72
|
-44.6 Percent Change of cells
Standard Deviation 30.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12, 24, 36, 52, and 72Population: All enrolled participants with Mature Naive B-Cells and Switched Memory B-Cells assessment at 1 or more of the specified timepoints.
Peripheral B cell subsets (Mature Naive B-cells and Switched Memory B cells) are disease-related peripheral blood biomarkers used to assess disease progression of RA. A reduction in cell values indicate an improvement in RA symptoms.
Outcome measures
| Measure |
Placebo/LY2127399 120 mg Q4W
n=25 Participants
Participants who previously received placebo in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 30 mg Q4W/120 mg Q4W
Participants who previously received 30 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 60 mg Q4W/120 mg Q4W
Participants who previously received 60 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q4W/120 mg Q4W
Participants who previously received 120 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q2W/120 mg Q4W
Participants who previously received 120 mg Q2W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Peripheral B-cell Subsets
Mature Naive B-Cell Week 12
|
-10.8 Percent Change of Cells
Standard Deviation 13.3
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Peripheral B-cell Subsets
Mature Naive B-Cell Week 24
|
-14.9 Percent Change of Cells
Standard Deviation 17.3
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Peripheral B-cell Subsets
Mature Naive B-Cell Week 36
|
-18.2 Percent Change of Cells
Standard Deviation 15.4
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Peripheral B-cell Subsets
Mature Naive B-Cell Week 52
|
-19.6 Percent Change of Cells
Standard Deviation 24.6
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Peripheral B-cell Subsets
Mature Naive B-Cell Week 72
|
7.6 Percent Change of Cells
Standard Deviation 18.5
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Peripheral B-cell Subsets
Switched Memory B-Cell Week 12
|
12.2 Percent Change of Cells
Standard Deviation 54.6
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Peripheral B-cell Subsets
Switched Memory B-Cell Week 24
|
28.7 Percent Change of Cells
Standard Deviation 76.7
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Peripheral B-cell Subsets
Switched Memory B-Cell Week 36
|
26.1 Percent Change of Cells
Standard Deviation 57.3
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Peripheral B-cell Subsets
Switched Memory B-Cell Week 52
|
50.9 Percent Change of Cells
Standard Deviation 106.8
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Peripheral B-cell Subsets
Switched Memory B-Cell Week 72
|
19.3 Percent Change of Cells
Standard Deviation 61.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12, 24, 36, 52, and 72Population: All enrolled participants with a CRP assessment at 1 or more of the specified timepoints.
CRP is a disease-related peripheral blood biomarker used to assess disease progression of RA. A reduction in CRP values indicate an improvement in RA symptoms.
Outcome measures
| Measure |
Placebo/LY2127399 120 mg Q4W
n=26 Participants
Participants who previously received placebo in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 30 mg Q4W/120 mg Q4W
Participants who previously received 30 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 60 mg Q4W/120 mg Q4W
Participants who previously received 60 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q4W/120 mg Q4W
Participants who previously received 120 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q2W/120 mg Q4W
Participants who previously received 120 mg Q2W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in C-Reactive Protein (CRP)
CRP Week 12
|
63.0 Percent Change of CRP
Standard Deviation 276.1
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in C-Reactive Protein (CRP)
CRP Week 24
|
15.4 Percent Change of CRP
Standard Deviation 106.9
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in C-Reactive Protein (CRP)
CRP Week 36
|
19.0 Percent Change of CRP
Standard Deviation 159.6
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in C-Reactive Protein (CRP)
CRP Week 52
|
-4.9 Percent Change of CRP
Standard Deviation 107.6
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in C-Reactive Protein (CRP)
CRP Week 72
|
7.1 Percent Change of CRP
Standard Deviation 110.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12, 24, 36, 52, and 72Population: All enrolled participants with an ESR assessment at 1 or more of the specific timepoints.
ESR is a disease related peripheral blood biomarker used to assess, in part, the effect of LY2127399 on the participants' RA disease progression. A reduction in ESR values indicate an improvement in RA symptoms.
Outcome measures
| Measure |
Placebo/LY2127399 120 mg Q4W
n=26 Participants
Participants who previously received placebo in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 30 mg Q4W/120 mg Q4W
Participants who previously received 30 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 60 mg Q4W/120 mg Q4W
Participants who previously received 60 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q4W/120 mg Q4W
Participants who previously received 120 mg Q4W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q2W/120 mg Q4W
Participants who previously received 120 mg Q2W of LY2127399 in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
ESR Week 12
|
-4.2 Percent Change of ESR
Standard Deviation 37.3
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
ESR Week 24
|
-7.8 Percent Change of ESR
Standard Deviation 38.8
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
ESR Week 36
|
-7.3 Percent Change of ESR
Standard Deviation 47.6
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
ESR Week 52
|
-4.0 Percent Change of ESR
Standard Deviation 60.9
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
ESR Week 72
|
-5.0 Percent Change of ESR
Standard Deviation 64.0
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo/LY2127399 120 mg Q4W
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
LY2127399 30 mg Q4W/120 mg Q4W
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
LY2127399 60 mg Q4W/120 mg Q4W
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
LY2127399 120 mg Q4W/120 mg Q4W
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
LY2127399 120 mg Q2W/120 mg Q4W
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo/LY2127399 120 mg Q4W
n=6 participants at risk
Participants who previously received placebo in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 30 mg Q4W/120 mg Q4W
n=6 participants at risk
Participants who previously received 30 mg Q4W of LY2127399 in Study BCDK were assigned to receive120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 60 mg Q4W/120 mg Q4W
n=4 participants at risk
Participants who previously received 60 mg Q4W of LY2127399 in Study BCDK were assigned to receive120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q4W/120 mg Q4W
n=5 participants at risk
Participants who previously received 120 mg Q4W of LY2127399 in Study BCDK were assigned to receive120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q2W/120 mg Q4W
n=5 participants at risk
Participants who previously received 120 mg Q2W of LY2127399 in Study BCDK were assigned to receive120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/5
|
Other adverse events
| Measure |
Placebo/LY2127399 120 mg Q4W
n=6 participants at risk
Participants who previously received placebo in Study BCDK were assigned to receive 120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 30 mg Q4W/120 mg Q4W
n=6 participants at risk
Participants who previously received 30 mg Q4W of LY2127399 in Study BCDK were assigned to receive120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 60 mg Q4W/120 mg Q4W
n=4 participants at risk
Participants who previously received 60 mg Q4W of LY2127399 in Study BCDK were assigned to receive120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q4W/120 mg Q4W
n=5 participants at risk
Participants who previously received 120 mg Q4W of LY2127399 in Study BCDK were assigned to receive120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
LY2127399 120 mg Q2W/120 mg Q4W
n=5 participants at risk
Participants who previously received 120 mg Q2W of LY2127399 in Study BCDK were assigned to receive120 mg of LY2127399 administered SC Q4W for 48 weeks.
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/5
|
|
Eye disorders
Dry eye
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Eye disorders
Keratoconjunctivitis sicca
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/5
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/5
|
|
Gastrointestinal disorders
Gastritis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/5
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/5
|
|
General disorders
Injection site erythema
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/6
|
0.00%
0/6
|
25.0%
1/4 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Infections and infestations
Cystitis
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/5
|
|
Infections and infestations
Enteritis infectious
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/5
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Infections and infestations
Herpes simplex
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/5
|
|
Infections and infestations
Influenza
|
0.00%
0/6
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Infections and infestations
Mycoplasma infection
|
0.00%
0/6
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
60.0%
3/5 • Number of events 4
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Investigations
Weight decreased
|
0.00%
0/6
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
40.0%
2/5 • Number of events 2
|
0.00%
0/5
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
Reproductive system and breast disorders
Metrorrhagia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6
|
0.00%
0/6
|
25.0%
1/4 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
Surgical and medical procedures
Joint arthroplasty
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/5
|
|
Surgical and medical procedures
Transfusion
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/5
|
|
Vascular disorders
Hypertension
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60