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Trial record 9 of 29 for:    LY2439821

A Study in Patients With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00966875
Recruitment Status : Completed
First Posted : August 27, 2009
Results First Posted : May 26, 2016
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Biological: LY2439821
Drug: Placebo
Enrollment 448
Recruitment Details  
Pre-assignment Details Participants were randomized to Part A and had the option of continuing in the open-label extension, Part B after completing Part A.
Arm/Group Title Placebo [bDMARD-naive Population] 3 mg LY2439821 [bDMARD-naive Population] 10 mg LY2439821 [bDMARD-naive Population] 30 mg LY2439821 [bDMARD-naive Population] 80 mg LY2439821 [bDMARD-naive Population] 180 mg LY2439821[bDMARD-naive Population] Placebo [TNFα-IR Population] 80 mg LY2439821 [TNFα-IR Population] 180 mg LY2439821 [TNFα-IR Population]
Hide Arm/Group Description Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 milligrams (mg) LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. [Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)] 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. [Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR)] 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Period Title: Part A
Started 54 40 35 37 57 37 64 65 59
Received ≥1 Doses of Study Drug 54 40 35 37 57 37 64 65 59
Completed 48 36 33 34 52 33 52 58 51
Not Completed 6 4 2 3 5 4 12 7 8
Reason Not Completed
Adverse Event             2             1             0             1             0             1             0             3             3
Entry Criteria             0             0             0             0             0             2             0             0             0
Lack of Efficacy             0             1             0             0             0             0             4             0             0
Lost to Follow-up             2             0             0             0             0             1             0             0             0
Parent/Caregiver Decision             0             0             0             1             0             0             0             0             0
Physician Decision             0             0             0             0             1             0             1             0             2
Sponsor Decision             0             0             1             0             1             0             0             2             1
Withdrawal by Subject             2             2             1             1             3             0             5             1             1
Protocol Violation             0             0             0             0             0             0             2             1             1
Period Title: Part B
Started 46 [1] 36 33 34 51 [2] 32 [2] 51 [2] 57 [2] 50 [2]
Completed 41 33 27 31 44 26 29 38 32
Not Completed 5 3 6 3 7 6 22 19 18
Reason Not Completed
Adverse Event             0             1             1             0             1             0             5             2             2
Death             0             0             1             0             0             0             0             1             0
Lack of Efficacy             2             1             1             1             2             3             12             9             6
Lost to Follow-up             0             0             0             1             0             0             0             0             1
Physician Decision             0             0             1             0             2             1             0             0             2
Sponsor Decision             1             0             0             0             0             1             0             2             1
Withdrawal by Subject             2             1             2             1             2             1             4             5             5
Entry Criteria             0             0             0             0             0             0             1             0             1
[1]
Two (2) participants who completed Part A did not enter Part B.
[2]
One (1) participant who completed Part A did not enter Part B.
Arm/Group Title Placebo [bDMARD-naive Population] 3 mg LY2439821 [bDMARD-naive Population] 10 mg LY2439821 [bDMARD-naive Population] 30 mg LY2439821 [bDMARD-naive Population 80 mg LY2439821 [bDMARD-naive Population] 180 mg LY2439821[bDMARD-naive Population] Placebo [TNFα-IR Population] 80 mg LY2439821 [TNFα-IR Population] 180 mg LY2439821 [TNFα-IR Population] Total
Hide Arm/Group Description Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. 3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. 10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. 30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. 80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. Total of all reporting groups
Overall Number of Baseline Participants 54 40 35 37 57 37 64 65 59 448
Hide Baseline Analysis Population Description
Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 40 participants 35 participants 37 participants 57 participants 37 participants 64 participants 65 participants 59 participants 448 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
45
  83.3%
37
  92.5%
30
  85.7%
29
  78.4%
48
  84.2%
32
  86.5%
59
  92.2%
55
  84.6%
52
  88.1%
387
  86.4%
>=65 years
9
  16.7%
3
   7.5%
5
  14.3%
8
  21.6%
9
  15.8%
5
  13.5%
5
   7.8%
10
  15.4%
7
  11.9%
61
  13.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 40 participants 35 participants 37 participants 57 participants 37 participants 64 participants 65 participants 59 participants 448 participants
52.99  (10.18) 52.19  (9.67) 53.86  (10.62) 53.03  (12.16) 52.60  (10.91) 52.21  (11.33) 53.19  (10.44) 54.74  (11.12) 52.43  (9.90) 53.08  (10.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 40 participants 35 participants 37 participants 57 participants 37 participants 64 participants 65 participants 59 participants 448 participants
Female
47
  87.0%
33
  82.5%
27
  77.1%
31
  83.8%
52
  91.2%
30
  81.1%
55
  85.9%
57
  87.7%
51
  86.4%
383
  85.5%
Male
7
  13.0%
7
  17.5%
8
  22.9%
6
  16.2%
5
   8.8%
7
  18.9%
9
  14.1%
8
  12.3%
8
  13.6%
65
  14.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 40 participants 35 participants 37 participants 57 participants 37 participants 64 participants 65 participants 59 participants 448 participants
Hispanic or Latino
9
  16.7%
7
  17.5%
8
  22.9%
7
  18.9%
10
  17.5%
6
  16.2%
15
  23.4%
23
  35.4%
15
  25.4%
100
  22.3%
Not Hispanic or Latino
45
  83.3%
32
  80.0%
24
  68.6%
29
  78.4%
46
  80.7%
30
  81.1%
48
  75.0%
41
  63.1%
43
  72.9%
338
  75.4%
Unknown or Not Reported
0
   0.0%
1
   2.5%
3
   8.6%
1
   2.7%
1
   1.8%
1
   2.7%
1
   1.6%
1
   1.5%
1
   1.7%
10
   2.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 40 participants 35 participants 37 participants 57 participants 37 participants 64 participants 65 participants 59 participants 448 participants
American Indian or Alaska Native
2
   3.7%
3
   7.5%
2
   5.7%
1
   2.7%
2
   3.5%
4
  10.8%
0
   0.0%
0
   0.0%
2
   3.4%
16
   3.6%
Asian
16
  29.6%
13
  32.5%
10
  28.6%
12
  32.4%
17
  29.8%
10
  27.0%
3
   4.7%
4
   6.2%
3
   5.1%
88
  19.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   7.4%
2
   5.0%
0
   0.0%
1
   2.7%
3
   5.3%
1
   2.7%
6
   9.4%
2
   3.1%
4
   6.8%
23
   5.1%
White
29
  53.7%
20
  50.0%
21
  60.0%
20
  54.1%
31
  54.4%
22
  59.5%
54
  84.4%
58
  89.2%
50
  84.7%
305
  68.1%
More than one race
3
   5.6%
2
   5.0%
2
   5.7%
3
   8.1%
4
   7.0%
0
   0.0%
1
   1.6%
1
   1.5%
0
   0.0%
16
   3.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants 40 participants 35 participants 37 participants 57 participants 37 participants 64 participants 65 participants 59 participants 448 participants
United States 12 9 8 8 12 9 33 32 31 154
Taiwan 5 4 3 4 4 3 1 1 1 26
Argentina 1 0 0 1 1 0 10 11 10 34
Poland 11 8 8 7 9 7 11 11 10 82
Romania 5 4 3 4 6 3 1 1 0 27
Peru 6 4 4 4 6 4 1 1 1 31
Chile 0 1 2 0 2 2 1 2 1 11
Russian Federation 3 1 0 1 3 2 1 1 1 13
Germany 0 0 0 0 1 0 3 2 2 8
Korea, Republic of 2 2 1 1 2 1 2 3 2 16
India 9 7 6 7 11 6 0 0 0 46
1.Primary Outcome
Title Dose-Response Relationship Measured by the Percentage of Participants With American College of Rheumatology (ACR) 20 Response in bDMARD-Naive Population
Hide Description ACR20 responders are participants with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measured participants perceived degree of difficulty performing daily activities, C-reactive Protein (CRP), Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), Patient’s Global Assessment of Disease Activity-VAS(PtGADA-VAS), and Physician’s Global Assessment of Disease Activity-VAS (PhGA-VAS). Missing values were imputed using Non-Responder Imputation (NRI). Percentage of participants achieving ACR20 response was calculated as: (number of ACR20 responders / number of participants treated) * 100.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.
Arm/Group Title Placebo (bDMARD-naive Population) 3 mg LY2439821 (bDMARD-naive Population) 10 mg LY2439821 (bDMARD-naive Population) 30 mg LY2439821 (bDMARD-naive Population) 80 mg LY2439821 (bDMARD-naive Population) 180 mg LY2439821 (bDMARD-naive Population)
Hide Arm/Group Description:
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Overall Number of Participants Analyzed 54 40 35 37 57 37
Measure Type: Number
Unit of Measure: percentage of participants
34.1 46.2 52.2 55.0 55.3 54.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 3 mg LY2439821 (bDMARD-naive Population), 10 mg LY2439821 (bDMARD-naive Population), 30 mg LY2439821 (bDMARD-naive Population), 80 mg LY2439821 (bDMARD-naive Population), 180 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments A log transformed dose was used in the model.
Method Regression, Logistic
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With ACR20 Response in Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR) Population
Hide Description ACR20 responders were participants with at least 20% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants achieving ACR20 response was calculated as: (number of ACR20 responders / number of participants treated) * 100.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part A FAS: All randomized participants who received at least 1 dose of study drug and were TNFα-IR.
Arm/Group Title Placebo (TNFα-IR Population) 80 mg LY2439821 (TNFα-IR Population) 180 mg LY2439821 (TNFα-IR Population)
Hide Arm/Group Description:
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Overall Number of Participants Analyzed 64 65 59
Measure Type: Number
Unit of Measure: percentage of participants
23.4 40.0 39.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 80 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.033
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 180 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR 20 Response in bDMARD-Naive Population
Hide Description ACR20 responders are participants with at least 20% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. The model used in the dose response analysis was used to estimate the doses that achieved 10%, 50%, and 90% of the maximal drug efficacy. Missing values were imputed using NRI. The log transformed dose was evaluated.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.
Arm/Group Title 3 mg to 180 mg LY2439821 (bDMARD-naive Population)
Hide Arm/Group Description:
3 mg to 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Overall Number of Participants Analyzed 206
Measure Type: Number
Unit of Measure: log (dose) mg
Estimated dose to achieve 10% response 0.8
Estimated dose to achieve 50% response 2.4
Estimated dose to achieve 90% response 13.8
4.Secondary Outcome
Title Smallest Doses That Achieved 10%, 50%, and 90% of the Maximum Disease Activity Score (DAS) 28 Response in bDMARD-Naive Population
Hide Description DAS modified included the 28 diarthrodial joint count (DAS28) that consisted of a composite score of the following variables: TJC out of 28 (TJC28), SJC out of 28 (SJC28), CRP [milligrams per liter (mg/L)], and PtGADA on a 0 to 100 millimeter (mm) VAS ranging from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). DAS28 was calculated as: DAS28 − CRP = 0.56(square root of TJC28) + 0.28(square root of SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.
Arm/Group Title 3 mg to 180 mg (bDMARD-naive Population)
Hide Arm/Group Description:
3 mg to 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Overall Number of Participants Analyzed 206
Measure Type: Number
Unit of Measure: log (dose) mg
Estimated dose to achieve 10% response 7.3
Estimated dose to achieve 50 % response 41.5
Estimated dose to achieve 90% response 97.0
5.Secondary Outcome
Title Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR50 Response in bDMARD-Naive Population
Hide Description ACR50 responders were participants with at least 50% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.
Arm/Group Title 3 mg to 180 mg LY2439821 (bDMARD-naive Population)
Hide Arm/Group Description:
3 mg to 180 mg LY2439821administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Overall Number of Participants Analyzed 206
Measure Type: Number
Unit of Measure: log (dose) mg
Estimated dose to achieve 10% response 7.3
Estimated dose to achieve 50% response 37.9
Estimated dose to achieve 90% response 81.2
6.Secondary Outcome
Title Change From Baseline in Disease Activity Score (DAS28)-Part A
Hide Description DAS28 consisted of a composite score of the following variables: TJC28, SJC28, CRP, and PtGADA-VAS. DAS28 was calculated as: DAS28 − CRP =0.56(square root TJC28) + 0.28(square root SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96. A negative change indicated an improvement.
Time Frame Baseline, up to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part A FAS: All randomized participants who received at least 1 dose of study drug; last observation carried forward (LOCF).
Arm/Group Title Placebo (bDMARD-naive Population) 3 mg LY2439821 (bDMARD-naive Population) 10 mg LY2439821 (bDMARD-naive Population) 30 mg LY2439821 (bDMARD-naive Population) 80 mg LY2439821 (bDMARD-naive Population) 180 mg LY2439821 (bDMARD-naive Population) Placebo (TNFα-IR Population) 80 mg LY2439821 (TNFα-IR Population) 180 mg LY2439821 (TNFα-IR Population)
Hide Arm/Group Description:
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Overall Number of Participants Analyzed 54 40 35 37 57 37 64 65 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.818  (0.981) -1.308  (1.092) -1.565  (1.440) -1.671  (1.193) -1.686  (1.344) -1.940  (1.152) -0.619  (1.109) -1.310  (1.303) -1.571  (1.261)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 3 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 10 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 30 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 80 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 180 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 80 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 180 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
7.Secondary Outcome
Title Change From Baseline in DAS28 - Part B
Hide Description DAS28 consisted of a composite score of the following variables: TJC28, SJC28, CRP, and PtGADA-VAS. DAS28 was calculated as: DAS28 − CRP =0.56(square root TJC28) + 0.28(square root SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96. A negative change indicated an improvement.
Time Frame Baseline, Week 64
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 DAS28 results.
Arm/Group Title Placebo/160 mg LY2439821 (bDMARD-naive Population) 3 mg/160 mg LY2439821(bDMARD-naive Population) 10 mg/160 mg LY2439821(bDMARD-naive Population) 30 mg/160 mg LY2439821(bDMARD-naive Population) 80 mg/160 mg LY2439821(bDMARD-naive Population) 180 mg/160 mg LY2439821 (bDMARD-naive Population) Placebo/160 mg LY2439821(TNFα-IR Population) 80 mg/160 mg LY2439821(TNFα-IR Population) 180 mg/160 mg LY2439821(TNFα-IR Population)
Hide Arm/Group Description:
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Overall Number of Participants Analyzed 41 33 28 31 44 26 31 41 33
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.143  (1.177) -1.832  (1.031) -2.320  (1.292) -2.277  (1.337) -2.280  (1.316) -2.475  (1.140) -1.740  (1.460) -1.604  (1.282) -1.874  (1.279)
8.Secondary Outcome
Title Percentage of Participants With ACR20/50/70 Response - Part A
Hide Description ACR20 (or ACR50 or ACR70) responders were participants with at least 20% (or 50% or 70%, respectively) improvement from baseline TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants was calculated as: (number of ACR20 [or ACR50 or ACR70] responders per treatment arm) / (total number of participants per treatment arm) * 100.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part A FAS: All randomized participants who received at least 1 dose of study drug.
Arm/Group Title Placebo (bDMARD-naive Population) 3 mg LY2439821 (bDMARD-naive Population) 10 mg LY2439821 (bDMARD-naive Population) 30 mg LY2439821 (bDMARD-naive Population) 80 mg LY2439821 (bDMARD-naive Population) 180 mg LY2439821 (bDMARD-naive Population) Placebo (TNFα-IR Population) 80 mg LY2439821 (TNFα-IR Population) 180 mg LY2439821 (TNFα-IR Population)
Hide Arm/Group Description:
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Overall Number of Participants Analyzed 54 40 35 37 57 37 64 65 59
Measure Type: Number
Unit of Measure: percentage of participants
ACR20 35.2 45.0 42.9 70.3 50.9 54.1 23.4 40.0 39.0
ACR50 9.3 17.5 28.6 29.7 26.3 27.0 7.8 20.0 16.9
ACR70 1.9 5.0 14.3 13.5 7.0 13.5 3.1 3.1 10.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 3 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.227
Comments P-value is for ACR20-NRI at Week 12.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 10 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.306
Comments P-value is for ACR20-NRI at Week 12.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 30 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments P-value is for ACR20-NRI at Week 12.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 80 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.070
Comments P-value is for ACR20-NRI at Week 12.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 180 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.058
Comments P-value is for ACR20-NRI at Week 12.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 80 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.033
Comments P-value is for ACR20-NRI at Week 12.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 180 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments P-value is for ACR20-NRI at Week 12.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 3 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.191
Comments P-value is for ACR50-NRI at Week 12.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 10 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments P-value is for ACR50-NRI at Week 12.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 30 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments P-value is for ACR50-NRI at Week 12.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 80 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments P-value is for ACR50-NRI at Week 12.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 180 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments P-value is for ACR50-NRI at Week 12.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 80 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments P-value is for ACR50-NRI at Week 12.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 180 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.102
Comments P-value is for ACR50-NRI at Week 12.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 3 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.388
Comments P-value is for ACR70-NRI at Week 12.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 10 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.033
Comments P-value is for ACR70-NRI at Week 12.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 30 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments P-value is for ACR70-NRI at Week 12.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 80 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.199
Comments P-value is for ACR70-NRI at Week 12.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 180 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments P-value is for ACR70-NRI at Week 12.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 80 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.696
Comments P-value is for ACR70-NRI at Week 12.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 180 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.112
Comments P-value is for ACR70-NRI at Week 12.
Method Fisher Exact
Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants With of ACR20/50/70 Response - Part B
Hide Description ACR20 (or ACR50 or ACR70) responders were participants with at least 20% (or 50% or 70% respectively) improvement from baseline TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants was calculated as: (number of ACR20 [or ACR50 or ACR70] responders per treatment arm) / (total number of participants per treatment arm) * 100].
Time Frame Week 64
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 ACR20/50/70 results.
Arm/Group Title Placebo/160 mg LY2439821(bDMARD-naive Population) 3 mg/160 mg LY2439821 (bDMARD-naive Population) 10 mg/160 mg LY2439821 (bDMARD-naive Population) 30 mg/160 mg LY2439821 (bDMARD-naive Population) 80 mg/160 mg LY2439821 (bDMARD-naive Population) 180 mg/160 mg LY2439821 (bDMARD-naive Population) Placebo/160 mg LY2439821(TNFα-IR Population) 80 mg/160 mg LY2439821 (TNFα-IR Population) 180 mg/160 mg LY2439821 (TNFα-IR Population)
Hide Arm/Group Description:
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Overall Number of Participants Analyzed 40 32 28 31 44 26 31 41 34
Measure Type: Number
Unit of Measure: percentage of participants
ACR20 75.0 65.6 67.9 80.6 72.7 80.8 51.6 43.9 64.7
ACR50 42.5 37.5 50.0 48.4 47.7 61.5 32.3 22.0 38.2
ACR70 17.5 12.5 32.1 22.6 11.4 30.8 19.4 9.8 17.6
10.Secondary Outcome
Title Change From Baseline in Individual Components of the ACR Core Set-TJC - Part A
Hide Description TJC was determined by examination of 28 joint counts that were assessed for tenderness by pressure and joint manipulation on physical examination. The participant was asked for pain sensations on these manipulations and was watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-non-tender dichotomy. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, arthrodesed joints were identified by the investigator and excluded from evaluation during the study. Any joints that required intra-articular injections during the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of tender joints ranged from 0-28. A negative change indicated fewer tender joints.
Time Frame Baseline, up to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.
Arm/Group Title Placebo (bDMARD-naive Population) 3 mg LY2439821 (bDMARD-naive Population) 10 mg LY2439821 (bDMARD-naive Population) 30 mg LY2439821 (bDMARD-naive Population) 80 mg LY2439821 (bDMARD-naive Population) 180 mg LY2439821 (bDMARD-naive Population) Placebo (TNFα-IR Population) 80 mg LY2439821 (TNFα-IR Population) 180 mg LY2439821 (TNFα-IR Population)
Hide Arm/Group Description:
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
3 milligram (mg) LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Overall Number of Participants Analyzed 54 40 35 37 56 37 64 65 59
Mean (Standard Deviation)
Unit of Measure: tender joints
-2.95  (5.20) -6.02  (7.35) -6.79  (7.67) -7.05  (6.28) -7.66  (8.96) -8.96  (7.47) -2.96  (6.31) -6.02  (7.31) -6.02  (6.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 3 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 10 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 30 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 80 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 180 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 80 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 180 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
11.Secondary Outcome
Title Change From Baseline in Individual Components of the ACR Core Set-TJC - Part B
Hide Description TJC was determined by examination of 28 joint counts that were assessed for tenderness by pressure and joint manipulation on physical examination. The participant was asked for pain sensations on these manipulations and was watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-non-tender dichotomy. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, arthrodesed joints were identified by the investigator and excluded from evaluation during the study. Any joints that required intra-articular injections during the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of tender joints ranged from 0-28. A negative change indicated fewer tender joints.
Time Frame Baseline, Week 64
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 TJC results.
Arm/Group Title Placebo/160 mg LY2439821(bDMARD-naive Population) 3 mg/160 mg LY2439821 (bDMARD-naive Population) 10 mg/160 mg LY2439821 (bDMARD-naive Population) 30 mg/160 mg LY2439821 (bDMARD-naive Population) 80 mg/160 mg LY2439821 (bDMARD-naive Population) 180 mg/160 mg LY2439821 (bDMARD-naive Population) Placebo/160 mg LY2439821(TNFα-IR Population) 80 mg/160 mg LY2439821 (TNFα-IR Population) 180 mg/160 mg LY2439821 (TNFα-IR Population)
Hide Arm/Group Description:
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Overall Number of Participants Analyzed 41 33 28 31 44 26 31 41 34
Mean (Standard Deviation)
Unit of Measure: tender joints
-8.73  (6.85) -8.78  (5.32) -11.43  (6.54) -9.55  (6.20) -10.86  (7.48) -10.55  (7.11) -6.62  (8.39) -7.35  (6.83) -6.81  (6.11)
12.Secondary Outcome
Title Change From Baseline in Individual Components of the ACR Core Set-SJC - Part A
Hide Description SJC was determined by examination of 28 joint that were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Swelling secondary to osteoarthrosis was assessed as not swollen, unless there was unmistakable fluctuation. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, or arthrodesed joints were identified by the investigator and were excluded from evaluation during the study. Any joints that required intra-articular injections over the course of the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of swollen joints count ranged from 0-28. A negative change indicated fewer swollen joints.
Time Frame Baseline, up to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.
Arm/Group Title Placebo (bDMARD-naive Population) 3 mg LY2439821 (bDMARD-naive Population) 10 mg LY2439821 (bDMARD-naive Population) 30 mg LY2439821 (bDMARD-naive Population) 80 mg LY2439821 (bDMARD-naive Population) 180 mg LY2439821 (bDMARD-naive Population) Placebo (TNFα-IR Population) 80 mg LY2439821 (TNFα-IR Population) 180 mg LY2439821 (TNFα-IR Population)
Hide Arm/Group Description:
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Overall Number of Participants Analyzed 54 40 35 37 56 37 64 65 59
Mean (Standard Deviation)
Unit of Measure: swollen joints
-2.69  (6.07) -4.25  (5.58) -6.51  (7.65) -6.16  (6.44) -7.49  (7.98) -6.52  (6.62) -1.69  (5.93) -5.57  (5.51) -5.15  (5.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 3 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.093
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 10 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 30 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 80 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 180 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 80 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 180 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
13.Secondary Outcome
Title Change From Baseline in Individual Components of the ACR Core Set-SJC - Part B
Hide Description SJC was determined by examination of 28 joint that were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Swelling secondary to osteoarthrosis was assessed as not swollen, unless there was unmistakable fluctuation. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, or arthrodesed joints were identified by the investigator and were excluded from evaluation during the study. Any joints that required intra-articular injections over the course of the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of swollen joints ranged from 0-28. A negative change indicated fewer swollen joints.
Time Frame Baseline, Week 64
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 SJC results.
Arm/Group Title Placebo/160 mg LY2439821(bDMARD-naive Population) 3 mg/160 mg LY2439821 (bDMARD-naive Population) 10 mg/160 mg LY2439821 (bDMARD-naive Population) 30 mg/160 mg LY2439821 (bDMARD-naive Population) 80 mg/160 mg LY2439821 (bDMARD-naive Population) 180 mg/160 mg LY2439821 (bDMARD-naive Population) Placebo/160 mg LY2439821(TNFα-IR Population) 80 mg/160 mg LY2439821 (TNFα-IR Population) 180 mg/160 mg LY2439821 (TNFα-IR Population)
Hide Arm/Group Description:
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Overall Number of Participants Analyzed 41 33 28 31 44 26 31 41 34
Mean (Standard Deviation)
Unit of Measure: swollen joints
-7.25  (6.15) -5.73  (4.95) -9.06  (5.92) -7.26  (5.73) -8.95  (6.64) -8.96  (6.06) -7.32  (6.45) -5.46  (6.51) -6.29  (5.75)
14.Secondary Outcome
Title Change From Baseline in Individual Components of the ACR Core Set-PAAP VAS - Part A
Hide Description Participants were asked to assess his/her current level of arthritis pain by marking a vertical tick on a 100-mm horizontal VAS with the left end (0 mm) marked as "no pain" and the right end (100 mm) marked "worst possible pain." The scale was administered prior to the TJC and SJC count examinations. Results were expressed in mm measured between the left end of the scale and the crossing point of the vertical line of the tick. A negative change indicated a lessening of the participant's arthritis pain.
Time Frame Baseline, up to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.
Arm/Group Title Placebo (bDMARD-naive Population) 3 mg LY2439821 (bDMARD-naive Population) 10 mg LY2439821 (bDMARD-naive Population) 30 mg LY2439821 (bDMARD-naive Population) 80 mg LY2439821 (bDMARD-naive Population) 180 mg LY2439821 (bDMARD-naive Population) Placebo (TNFα-IR Population) 80 mg LY2439821 (TNFα-IR Population) 180 mg LY2439821 (TNFα-IR Population)
Hide Arm/Group Description:
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Overall Number of Participants Analyzed 54 40 35 37 56 37 63 65 56
Mean (Standard Deviation)
Unit of Measure: mm
-14.8  (23.7) -18.7  (22.8) -21.3  (28.4) -29.8  (24.1) -25.8  (23.0) -25.3  (27.5) -9.4  (24.0) -10.3  (24.7) -18.8  (26.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 3 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.247
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 10 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.315
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 30 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 80 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 180 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.055
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 80 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.365
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 180 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
15.Secondary Outcome
Title Change From Baseline in Individual Components of the ACR Core Set-PAAP-VAS - Part B
Hide Description Participants were asked to assess his/her current level of arthritis pain by marking a vertical tick on a 100-mm horizontal VAS with the left end (0 mm) marked as "no pain" and the right end (100 mm) marked "worst possible pain". The scale was administered prior to the TJC and SJC count examinations. Results were expressed in mm measured between the left end of the scale and the crossing point of the vertical line of the tick. A negative change indicated a lessening of the participant's arthritis pain.
Time Frame Baseline, Week 64
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 PAAP-VAS results.
Arm/Group Title Placebo/160 mg LY2439821 (bDMARD-naive Population) 3 mg/160 mg LY2439821 (bDMARD-naive Population) 10 mg/160 mg LY2439821 (bDMARD-naive Population) 30 mg/160 mg LY2439821 (bDMARD-naive Population) 80 mg/160 mg LY2439821 (bDMARD-naive Population) 180 mg/160 mg LY2439821 (bDMARD-naive Population) Placebo/160 mg LY2439821 (TNFα-IR Population) 80 mg/160 mg LY2439821 (TNFα-IR Population) 180 mg/160 mg LY2439821 (TNFα-IR Population)
Hide Arm/Group Description:
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Overall Number of Participants Analyzed 41 33 28 31 44 26 31 41 34
Mean (Standard Deviation)
Unit of Measure: mm
-32.5  (27.8) -26.2  (20.3) -33.3  (33.4) -36.2  (27.4) -32.4  (22.6) -41.2  (23.0) -25.5  (22.3) -16.5  (21.1) -26.2  (26.2)
16.Secondary Outcome
Title Change From Baseline in Individual Components of the ACR Core Set - PtGADA-VAS - Part A
Hide Description The participant was asked to give an overall assessment of his/her current arthritis disease activity. The participants response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as "no arthritis activity" to the right end (100 mm) marked "extremely active arthritis." A negative change indicated an improvement in the participant's assessment of disease activity.
Time Frame Baseline, up to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.
Arm/Group Title Placebo (bDMARD-naive Population) 3 mg LY2439821 (bDMARD-naive Population) 10 mg LY2439821 (bDMARD-naive Population) 30 mg LY2439821 (bDMARD-naive Population) 80 mg LY2439821 (bDMARD-naive Population) 180 mg LY2439821 (bDMARD-naive Population) Placebo (TNFα-IR Population) 80 mg LY2439821 (TNFα-IR Population) 180 mg LY2439821 (TNFα-IR Population)
Hide Arm/Group Description:
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Overall Number of Participants Analyzed 54 40 35 37 56 37 63 65 58
Mean (Standard Deviation)
Unit of Measure: mm
-19.2  (21.4) -17.3  (20.9) -18.5  (28.7) -29.1  (23.1) -22.1  (23.7) -30.1  (26.9) -10.1  (24.7) -12.1  (27.9) -21.6  (25.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 3 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.778
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 10 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.865
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 30 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 80 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.331
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 180 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments P-value is for Week 12..
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 80 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.292
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 180 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
17.Secondary Outcome
Title Change From Baseline in Individual Components of the ACR Core Set - PtGADA-VAS - Part B
Hide Description The participant was asked to give an overall assessment of his/her current arthritis disease activity. The participants response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as "no arthritis activity" to the right end (100 mm) marked "extremely active arthritis." A negative change indicated an improvement in the participant's assessment of disease activity.
Time Frame Baseline, Week 64
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 PtGADA-VAS results.
Arm/Group Title Placebo/160 mg LY2439821 (bDMARD-naive Population) 3 mg/160 mg LY2439821 (bDMARD-naive Population) 10 mg/160 mg LY2439821 (bDMARD-naive Population) 30 mg/160 mg LY2439821 (bDMARD-naive Population) 80 mg/160 mg LY2439821 (bDMARD-naive Population) 180 mg/160 mg LY2439821 (bDMARD-naive Population) Placebo/160 mg LY2439821 (TNFα-IR Population) 80 mg/160 mg LY2439821 (TNFα-IR Population) 180 mg/160 mg LY2439821 (TNFα-IR Population)
Hide Arm/Group Description:
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Overall Number of Participants Analyzed 41 32 28 31 44 26 31 41 33
Mean (Standard Deviation)
Unit of Measure: mm
-35.4  (26.2) -24.9  (25.4) -31.8  (30.4) -34.8  (27.0) -28.5  (24.7) -39.8  (25.5) -22.4  (23.2) -17.8  (21.4) -25.1  (23.9)
18.Secondary Outcome
Title Change From Baseline in Individual Components of the ACR Core Set - PhGA-VAS - Part A
Hide Description The investigator gave an overall assessment of the severity of the participants disease activity. The physician's response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as "no arthritis activity" and the right end (100 mm) marked as "extremely active arthritis." A negative change indicated a lessening in the severity of the participant's disease activity.
Time Frame Baseline, up to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.
Arm/Group Title Placebo (bDMARD-naive Population) 3 mg LY2439821 (bDMARD-naive Population) 10 mg LY2439821 (bDMARD-naive Population) 30 mg LY2439821 (bDMARD-naive Population) 80 mg LY2439821 (bDMARD-naive Population) 180 mg LY2439821 (bDMARD-naive Population) Placebo (TNFα-IR Population) 80 mg LY2439821 (TNFα-IR Population) 180 mg LY2439821 (TNFα-IR Population)
Hide Arm/Group Description:
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Overall Number of Participants Analyzed 54 40 35 37 56 37 64 65 59
Mean (Standard Deviation)
Unit of Measure: mm
-16.0  (19.0) -21.0  (15.6) -21.7  (25.2) -26.7  (18.1) -24.5  (22.3) -28.8  (24.2) -8.6  (21.4) -25.7  (22.2) -22.0  (24.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 3 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.090
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 10 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.131
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 30 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 80 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 180 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 80 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 180 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
19.Secondary Outcome
Title Change From Baseline in Individual Components of the ACR Core Set - PhGA-VAS - Part B
Hide Description The investigator gave an overall assessment of the severity of the participant's disease activity. The physician's response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as "no arthritis activity" and the right end (100 mm) marked as "extremely active arthritis." A negative change indicated a lessening in the severity of the participant's disease activity.
Time Frame Baseline, Week 64
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 PhGA-VAS results.
Arm/Group Title Placebo/160 mg LY2439821 (bDMARD-naive Population) 3 mg/160 mg LY2439821 (bDMARD-naive Population) 10 mg/160 mg LY2439821 (bDMARD-naive Population) 30 mg/160 mg LY2439821 (bDMARD-naive Population) 80 mg/160 mg LY2439821 (bDMARD-naive Population) 180 mg/160 mg LY2439821 (bDMARD-naive Population) Placebo/160 mg LY2439821 (TNFα-IR Population) 80 mg/160 mg LY2439821 (TNFα-IR Population) 180 mg/160 mg LY2439821 (TNFα-IR Population)
Hide Arm/Group Description:
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Overall Number of Participants Analyzed 41 33 28 31 44 26 31 41 34
Mean (Standard Deviation)
Unit of Measure: mm
-36.1  (21.7) -30.1  (22.0) -38.5  (28.4) -38.0  (18.5) -31.0  (20.7) -44.4  (17.7) -30.1  (22.5) -28.9  (25.8) -32.7  (25.2)
20.Secondary Outcome
Title Change From Baseline in Individual Components of the ACR Core Set - CRP - Part A
Hide Description CRP is a biological marker of disease activity. A negative change indicated an improvement in participant's disease activity.
Time Frame Baseline, up to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.
Arm/Group Title Placebo (bDMARD-naive Population) 3 mg LY2439821 (bDMARD-naive Population) 10 mg LY2439821 (bDMARD-naive Population) 30 mg LY2439821 (bDMARD-naive Population) 80 mg LY2439821 (bDMARD-naive Population) 180 mg LY2439821 (bDMARD-naive Population) Placebo (TNFα-IR Population) 80 mg LY2439821 (TNFα-IR Population) 180 mg LY2439821 (TNFα-IR Population)
Hide Arm/Group Description:
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Overall Number of Participants Analyzed 54 40 35 37 56 37 64 65 59
Mean (Standard Deviation)
Unit of Measure: mg/L
-1.575  (22.336) -6.079  (10.289) -9.435  (23.148) -7.999  (14.740) -11.968  (19.792) -13.575  (25.692) 1.229  (14.811) -9.521  (20.312) -8.297  (21.955)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 3 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 10 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 30 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 80 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 180 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 80 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 180 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments P-value is for Week 12.
Method ANCOVA
Comments ANCOVA adjusted for treatment and baseline value.
21.Secondary Outcome
Title Change From Baseline in Individual Components of the ACR Core Set - CRP - Part B
Hide Description CRP is a biological marker of disease activity. A negative change indicated an improvement in participant's disease activity.
Time Frame Baseline, Week 64
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 CRP results.
Arm/Group Title Placebo/160 mg LY2439821 (bDMARD-naive Population) 3 mg/160 mg LY2439821 (bDMARD-naive Population) 10 mg/160 mg LY2439821 (bDMARD-naive Population) 30 mg/160 mg LY2439821 (bDMARD-naive Population) 80 mg/160 mg LY2439821 (bDMARD-naive Population) 180 mg/160 mg LY2439821 (bDMARD-naive Population) Placebo/160 mg LY2439821 (TNFα-IR Population) 80 mg/160 mg LY2439821 (TNFα-IR Population) 180 mg/160 mg LY2439821 (TNFα-IR Population)
Hide Arm/Group Description:
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Overall Number of Participants Analyzed 41 33 28 31 44 26 30 40 34
Mean (Standard Deviation)
Unit of Measure: mg/L
-10.548  (18.555) -4.556  (12.937) -11.340  (23.347) -7.865  (22.607) -14.519  (19.260) -6.860  (16.745) -12.094  (28.917) -10.130  (18.030) -9.004  (19.698)
22.Secondary Outcome
Title Percentage of Participants in European League Against Rheumatism Responder Index (EULAR) 28 - Part A
Hide Description Assessment of participant's rheumatoid arthritis (RA) by the EULAR that is based on the DAS 28 joint count. Participants were categorized as non-responders or responders (moderate responders + good responders). Percentage of participants was calculated as: (number of responders / number of participants) * 100.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.
Arm/Group Title Placebo (bDMARD-naive Population) 3 mg LY2439821 (bDMARD-naive Population) 10 mg LY2439821 (bDMARD-naive Population) 30 mg LY2439821 (bDMARD-naive Population) 80 mg LY2439821 (bDMARD-naive Population) 180 mg LY2439821 (bDMARD-naive Population]) Placebo (TNFα-IR Population) 80 mg LY2439821 (TNFα-IR Population) 180 mg LY2439821 (TNFα-IR Population)
Hide Arm/Group Description:
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Overall Number of Participants Analyzed 54 40 35 37 56 37 63 65 58
Measure Type: Number
Unit of Measure: percentage of participants
44.4 67.5 60.0 75.7 73.2 75.7 36.5 60.0 65.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 3 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments P-value is for Week 12 LOCF.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 10 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.076
Comments P-value is for Week 12 LOCF.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 30 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-value is for Week 12 LOCF.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 80 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is for Week 12 LOCF.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 180 mg LY2439821 (bDMARD-naive Population])
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-value is for Week 12.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 80 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments P-value is for Week 12 LOCF.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 180 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments P-value is for Week 12.
Method Fisher Exact
Comments [Not Specified]
23.Secondary Outcome
Title Percentage of Participants in EULAR28 - Part B
Hide Description Assessment of participant's RA by the EULAR that is based on the DAS28 joint count. Participants were categorized as non-responders or responders (moderate responders + good responders). Percentage of participants was calculated as: (number of responders / number of participants) * 100.
Time Frame Week 64
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 EULAR28 results.
Arm/Group Title Placebo/160 mg LY2439821 (bDMARD-naive Population) 3 mg/160 mg LY2439821 (bDMARD-naive Population) 10 mg/160 mg LY2439821 (bDMARD-naive Population) 30 mg/160 mg LY2439821 (bDMARD-naive Population) 80 mg/160 mg LY2439821 (bDMARD-naive Population) 180 mg/160 mg LY2439821 (bDMARD-naive Population) Placebo/160 mg LY2439821 (TNFα-IR Population) 80 mg/160 mg LY2439821 (TNFα-IR Population) 180 mg/160 mg LY2439821 (TNFα-IR Population)
Hide Arm/Group Description:
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Overall Number of Participants Analyzed 41 33 28 31 44 26 31 41 33
Measure Type: Number
Unit of Measure: percentage of participants
90.2 81.8 82.1 83.9 84.1 88.5 64.5 73.2 69.7
24.Secondary Outcome
Title ACR-N - Part A
Hide Description ACR-N was a continuous measure of clinical, laboratory and functional outcomes in RA that characterized the percentage of improvement in RA disease activity from baseline. The index was defined as the lowest of either: the percent change in TJC, the percent change in SJC, or the median percent change of the remaining 5 ACR core criteria: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. For each criterion, percent change was calculated as: [(post baseline value - baseline value) / baseline value] * 100.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part A FAS: All randomized participants who received at least 1 dose of study drug with results at Week 12; LOCF.
Arm/Group Title Placebo (bDMARD-naive Population) 3 mg LY2439821 (bDMARD-naive Population) 10 mg LY2439821 (bDMARD-naive Population) 30 mg LY2439821 (bDMARD-naive Population) 80 mg LY2439821 (bDMARD-naive Population) 180 mg LY2439821(bDMARD-naive Population) Placebo (TNFα-IR Population) 80 mg LY2439821 (TNFα-IR Population) 180 mg LY2439821 (TNFα-IR Population)
Hide Arm/Group Description:
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Overall Number of Participants Analyzed 47 36 34 36 54 35 56 60 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
-11.034  (104.809) -0.699  (139786) 15.162  (51.130) 11.137  (128.516) 18.351  (41.493) 23.375  (42.173) -7.356  (45.724) 2.264  (59.277) 11.541  (49.358)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 3 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.307
Comments P-value is for Week 12.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 10 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.104
Comments P-value is for Week 12.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 30 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.139
Comments P-value is for Week 12.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 80 mg LY2439821 (bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments P-value is for Week 12.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo (bDMARD-naive Population), 180 mg LY2439821(bDMARD-naive Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments P-value is for Week 12.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 80 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.160
Comments P-value is for Week 12.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo (TNFα-IR Population), 180 mg LY2439821 (TNFα-IR Population)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments P-value is for Week 12.
Method ANCOVA
Comments [Not Specified]
25.Secondary Outcome
Title ACR-N - Part B
Hide Description ACR-N was a continuous measure of clinical, laboratory and functional outcomes in RA that characterized the percentage of improvement in RA disease activity from baseline. The index was defined as the lowest of either: the percent change in TJC, the percent change in SJC, or the median percent change of the remaining 5 ACR core criteria: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. For each criterion, percent change was calculated as: [(post baseline value - baseline value)/baseline value] * 100.
Time Frame Week 64
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 ACR-N results.
Arm/Group Title Placebo/160 mg LY2439821 (bDMARD-naive Population) 3 mg/160 mg LY2439821 (bDMARD-naive Population) 10 mg/160 mg LY2439821 (bDMARD-naive Population) 30 mg/160 mg LY2439821 (bDMARD-naive Population) 80 mg LY2439821 (bDMARD-naive Population) 180 mg LY2439821 (bDMARD-naive Population) Placebo (TNFα-IR Population) 80 mg LY2439821 (TNFα-IR Population) 180 mg LY2439821 (TNFα-IR Population)
Hide Arm/Group Description:
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Overall Number of Participants Analyzed 40 32 28 31 44 26 31 41 34
Mean (Standard Deviation)
Unit of Measure: units on a scale
36.839  (42.241) 33.154  (32.439) 39.922  (37.930) 34.847  (69.410) 38.996  (30.715) 49.152  (31.544) 22.230  (54.682) 14.389  (45.461) 30.891  (41.415)