An Open Label Extension Study in Participants With Rheumatoid Arthritis
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00837811
Collaborator
(none)
182
62
1
35
2.9
0.1
Study Details
Study Description
Brief Summary
To evaluate the safety and tolerability of LY2127399 administered as subcutaneous injections for 48 weeks in participants with Rheumatoid Arthritis
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
182 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Rheumatoid Arthritis.
Study Start Date
:
Feb 1, 2009
Actual Primary Completion Date
:
Jan 1, 2011
Actual Study Completion Date
:
Jan 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LY2127399
|
Biological: LY2127399
60 milligrams [(mg) with potential for dose escalation to 120 mg] subcutaneously every 4 weeks for 48 weeks
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52)]
A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module. Participants were on treatment up to 48 weeks. If a participant completed 48 weeks of treatment, the post-study treatment follow-up started at the next visit, 4 weeks later (Week 52). If a participant discontinued treatment early [early discontinuation (ED)], the post-study treatment follow-up started immediately afterwards. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)].
- Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs [Baseline through Week 112]
For each planned laboratory evaluation, the range of values to be reported as AEs, regardless of causality, was pre-specified. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)].
Secondary Outcome Measures
- Change From Baseline in Tender Joint Count [Individual Component of the American College of Rheumatology (ACR) Core Set] [Baseline, up to and through Week 52]
The number of tender and painful joints was determined by examination of 28 joints (14 on each side) which included: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. Joints were assessed by pressure and joint manipulation on physical examination. The participant was asked for pain sensations on these manipulations and the investigator watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in tender joint count indicated an improvement in the participant's condition.
- Change From Baseline in Swollen Joint Count (Individual Component of the ACR Core Set) [Baseline, up to and through Week 52]
The number of swollen joints was determined by examination of 28 joints (14 on each side) which included: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in swollen joint count indicated an improvement in the participant's condition.
- Change From Baseline in Participant's Assessment of Disease Activity (Individual Component of the ACR Core Set) [Baseline, up to and through Week 52]
Participant's assessment of their current arthritis disease activity using a visual analog scale (VAS), which ranged from 0 millimeters (mm) (no arthritis activity) to 100 mm (extremely active arthritis). Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in disease activity score indicated an improvement in the participant's condition.
- Change From Baseline in Physician's Global Assessment of Disease Activity (Individual Component of the ACR Core Set) [Baseline, up to and through Week 52]
Physician's assessment of disease activity using a VAS that ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in disease activity score indicated an improvement in the participant's condition.
- Change From Baseline in Health Assessment Questionnaire-Disability Index [(HAQ-DI) Individual Component of the ACR Core Set] [Baseline, up to and through Week 52]
The disability section of the health assessment questionnaire scored the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area, which ranged from 0 (no disability) to 3 (severe disability), were averaged to calculate HAQ-DI. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in HAQ-DI score indicated an improvement in the participant's condition.
- Change From Baseline in Participant's Assessment of Joint Pain (Individual Component of the ACR Core Set) [Baseline, up to and through Week 52]
Participant's assessment of joint pain using a VAS, which ranged from 0 mm (no pain) to 100 mm (worst possible pain). Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in joint pain indicated an improvement in the participant's condition.
- Percent Change From Baseline in C-Reactive Protein [(CRP) Individual Component of the ACR Core Set] [Baseline, up to and through Week 52]
CRP is an indicator of inflammation. The percentage of change in CRP from baseline=[(post-baseline CRP-baseline CRP)/baseline CRP]*100. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A negative change indicated an improvement in the participant's condition.
- Percentage of Participants Achieving ACR20 Response [Baseline, up to and through Week 52]
ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had ≥20% improvement from baseline in both tender and swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR20 response=(number of ACR20 responders/number of participants treated)*100. Participants who discontinued from study prior to Week 52 were imputed as non-responders. Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF. This composite data imputation was denoted as non-responder imputation (NRI)/LOCF. Baseline: the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
- Percentage of Participants ACR50 Response [Baseline, up to and through Week 52]
ACR50 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR50 Responder: had ≥50% improvement from baseline in both tender and swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR50 response=(number of ACR50 responders/number of participants treated)*100. Participants who discontinued from study prior to Week 52 were imputed as non-responders. Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF. This composite data imputation was denoted as NRI/LOCF. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
- Percentage of Participants Achieving ACR70 Response [Baseline, up to and through Week 52]
ACR70 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR70 Responder: had ≥70% improvement from baseline in both tender and swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR70 response=(number of ACR70 responders/number of participants treated)*100. Participants who discontinued from study prior to Week 52 were imputed as non-responders. Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF. This composite data imputation was denoted as NRI/LOCF. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
- ACR-N Response [Baseline, up to and through Week 52]
The ACR-N Responder Index was a composite of clinical, laboratory, and functional measures of rheumatoid arthritis. This index was defined as the lowest of either a) percent change in tender joint count, b) percent change in swollen joint count, or c) median percent change in 5 core ACR criteria: participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. For example, a participant with an ACR-N of X had an improvement ≥X% in both tender and swollen joint counts and a median improvement ≥X% in the 5 criteria previously mentioned. Baseline was the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. Results for the 60/120/60 mg LY2127399 treatment arm were not analyzed as the participant did not have an ACR assessment.
- Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score [Baseline, up to and through Week 52]
The FACIT Fatigue Scale was a brief participant-reported measure of fatigue and consisted of 13 items. Scores ranged from 0 to 52, where higher scores indicated less fatigue. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. An increase in FACIT fatigue score indicated an improvement of the participant's condition.
- Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) [Baseline, up to and through Week 52]
The DAS28 consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP (milligrams per liter [mg/L]), and participant global assessment of his or her disease activity using a VAS (participant global VAS). The DAS28 was calculated by using the following formula: DAS28-CRP=0.56*square root(TJC28)+0.28*square root(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. Scores ranged from 1.0 to 9.4 where lower scores indicated less disease activity and remission is DAS28 <2.6. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in DAS28 indicated an improvement in the participant's condition.
- Percentage of Participants With Response Based on European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28) [Baseline, up to and through Week 52]
EULAR28 was defined by the participant's change from baseline in DAS28 score and the absolute DAS28 score achieved. DAS28 consisted of composite score of the following: tender joint count, swollen joint count, CRP, and participant global assessment of his\her disease activity (participant global VAS). EULAR28 categories included: No Response [improvement in DAS28 ≤0.6 units (u) or post-baseline DAS28 score >5.1 with improvement ≤1.2 u], Moderate Response (post-baseline DAS28 score ≤5.1 with improvement >0.6 u but <1.2 u or post-baseline DAS28 score >3.2 with improvement >1.2 u), and Good Response (post-baseline DAS28 score ≤3.2 with improvement >1.2 u). Baseline was the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. Percentage of participants=(number of participants with specific response/participants assessed)*100. Displayed percentages may not add up to 100% because of rounding.
- Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores [Baseline, up to and through Week 52]
SF-36 was a 36-item, health-related survey that assessed participant's quality of life on 8 domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health, mental health, social functioning, vitality and 2 component scores (mental and physical health). Domain scores calculated by summing individual items for each domain and transforming scores into 0 to 100 scale; higher scores indicated better health status. The mental component summary (MCS) score, based on SF-36 domains, consisted of social functioning, vitality, mental health, and role-emotional scales (range: 0 to 100). The physical component summary (PCS) score, based on SF-36 domains, consisted of physical functioning, bodily pain, role-physical, and general health scales (range: 0 to 100). Baseline: last assessment prior to participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
- Pharmacodynamics: Change From Baseline in Total B Cells [Cluster Designation 20+ (CD20+)] Absolute Cell Counts [Baseline, Weeks 52, 60, 72, 80, 88, and 100]
B-lymphocyte antigen CD20+ is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928). A negative change indicated a decrease in cell count.
- Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts) [Baseline, Weeks 52, 60, 72, 80, 88, and 100]
Cell surface marker CD19, CD27, and immunoglobulin D (IgD) expression levels were used to define the various B cell subsets. Cell surface markers were defined as being either present (+) or absent (-). Peripheral blood B cell subsets included: mature naive cells (CD19+IgD+CD27-); immature/transitional cells (CD19+IgD-CD27-); switched memory (CD19+IgD-CD27+); and non-switched memory (CD19+IgD+CD27+). Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928). A negative change indicated a decrease in cell count.
- Pharmacodynamics: Change From Baseline in Serum Immunoglobulin [Baseline, up to Week 52]
Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin A (IgA) levels are reported. Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928). A negative change indicated a decrease in immunoglobulin levels.
- Pharmacodynamics: Change From Baseline in Rheumatoid Factor (RF) Levels at Week 52 [Baseline, Week 52]
RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. Higher RF levels indicate an aggressive rheumatoid arthritis and a higher risk of joint damage. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. A decrease in RF levels indicated an improvement in the participant's condition. Results for the 60/120/60 mg LY2127399 treatment arm were not analyzed as the participant did not have a Week 52 RF level assessment.
- Pharmacodynamics: Change From Baseline in Serum Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies [Baseline, up to Week 52]
Anti-CCP antibodies were measured using an enzyme-linked immunosorbent assay (ELISA) method. In general, high levels of the antibody indicated an aggressive rheumatoid arthritis and a higher risk of joint damage. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. A decrease in anti-CCP antibodies indicated an improvement in the participant's condition.
- Pharmacodynamics: Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR) [Baseline, up to Week 52]
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. Normal range was considered to be 0 to 20 or 0 to 30 millimeters per hour (mm/h), depending on the reference range used by the laboratory. Higher scores indicated greater inflammation. Percent change from baseline ESR=[(post-baseline ESR- baseline ESR)/baseline ESR]*100. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. A decrease in ESR indicated an improvement in the participant's condition.
- Number of Participants With LY2127399 Immunogenicity (Anti-LY2127399 Antibodies) [Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post-study treatment follow-up (start of Week 53 or ED up to and through Week 112)]
The number of participants who had treatment-emergent or follow-up emergent anti-LY2127399 antibodies [anti-drug antibodies (ADA)] is reported. Treatment-emergent was defined as participants who had any sample from baseline through Week 52 that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Follow-up emergent was defined as any sample during follow-up that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer. The number of participants with baseline positive ADA data is also reported. Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928).
Other Outcome Measures
- Number of Participants Who Died, Any Cause [Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post-study treatment follow-up (start of Week 53 or ED up to and through Week 72 and start of Week 73 up to and through Week 112)]
A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. Participants were on treatment up to 48 weeks. If a participant completed 48 weeks of treatment, the post-study treatment follow-up started at the next visit, 4 weeks later (Week 52). If a participant discontinued treatment early, the post-study treatment follow-up started immediately afterwards. After treatment discontinuation, participants could be followed beyond Week 72 for B cell recovery (up to Week 112).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Have given written informed consent
-
Women must not be pregnant, breastfeeding or be at risk to become pregnant during study participation
-
Have participated in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)
Exclusion Criteria:
-
Have had, during Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928), any safety event, [including having a recent, ongoing, or serious infection, a serious drug reaction, or any adverse event (AE) that caused discontinuation from treatment] that in the opinion of the investigator poses an unacceptable risk to participation in the study.
-
Have received, during Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928), any drug not allowed by the study protocol including unapproved drugs, biologic disease-modifying anti-rheumatic drugs (DMARDs), or live vaccines.
-
Enrollment in any other clinical trial involving off-label use of an investigational drug or device, or enrollment in any other type of medical research.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Birmingham | Alabama | United States | 35205 |
| 2 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Huntsville | Alabama | United States | 35801 |
| 3 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mesa | Arizona | United States | 85208 |
| 4 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Palm Desert | California | United States | 92260 |
| 5 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Riverside | California | United States | 92501 |
| 6 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Santa Maria | California | United States | 93454 |
| 7 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Upland | California | United States | 91786 |
| 8 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Jupiter | Florida | United States | 33458 |
| 9 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Vero Beach | Florida | United States | 32960 |
| 10 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Zephyrhills | Florida | United States | 33542 |
| 11 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Baltimore | Maryland | United States | 21239 |
| 12 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Saint Louis | Missouri | United States | 63141 |
| 13 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hickory | North Carolina | United States | 28601 |
| 14 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Middleburg Heights | Ohio | United States | 44130 |
| 15 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Philadelphia | Pennsylvania | United States | 19152 |
| 16 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Orangeburg | South Carolina | United States | 29118 |
| 17 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Memphis | Tennessee | United States | 38119 |
| 18 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Dallas | Texas | United States | 75231 |
| 19 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mesquite | Texas | United States | 75150 |
| 20 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Elizabeth Vale | South Australia | Australia | 5112 |
| 21 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Vienna | Austria | 1100 | |
| 22 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Liege | Belgium | 4000 | |
| 23 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Campinas | Brazil | 13015-011 | |
| 24 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Curitiba | Brazil | 80060-240 | |
| 25 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Goiania | Brazil | 74605-050 | |
| 26 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Porto Alegre | Brazil | 90610-970 | |
| 27 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Setor Oeste/Goiania | Brazil | 74100-125 | |
| 28 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Winnipeg | Manitoba | Canada | R3A 1M4 |
| 29 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hamilton | Ontario | Canada | N2M 5N6 |
| 30 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kitchener | Ontario | Canada | N2M 5N6 |
| 31 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Santiago | Chile | ||
| 32 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Valdivia | Chile | ||
| 33 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Vina Del Mar | Chile | ||
| 34 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hildesheim | Germany | 31134 | |
| 35 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Leipzig | Germany | 04103 | |
| 36 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Budapest | Hungary | 1023 | |
| 37 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Esztergom | Hungary | 2500 | |
| 38 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kistarcsa | Hungary | 2143 | |
| 39 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Szolnok | Hungary | 5000 | |
| 40 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lucknow | India | 226018 | |
| 41 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pune | India | 411001 | |
| 42 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Secunderabad | India | 500003 | |
| 43 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chihuahua | Mexico | 31000 | |
| 44 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cuernavaca | Mexico | 62270 | |
| 45 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Guadalajara | Mexico | 44100 | |
| 46 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mexico City | Mexico | 06700 | |
| 47 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Monterrey | Mexico | 64000 | |
| 48 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Luis Potosi | Mexico | 78210 | |
| 49 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tampico | Mexico | 89000 | |
| 50 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bialystok | Poland | 15-337 | |
| 51 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chelm Slaski | Poland | 41-403 | |
| 52 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Elblag | Poland | 82-300 | |
| 53 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Krakow | Poland | 30-510 | |
| 54 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lubin | Poland | 20-022 | |
| 55 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lublin | Poland | 20-954 | |
| 56 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Poznan | Poland | 60-356 | |
| 57 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Torun | Poland | 87-100 | |
| 58 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Warsaw | Poland | 00-235 | |
| 59 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Wroclaw | Poland | 50-088 | |
| 60 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Juan | Puerto Rico | 00918 | |
| 61 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Brasov | Romania | 500365 | |
| 62 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Targu-Mures | Romania | 540136 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UCT/GMT-5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00837811
Other Study ID Numbers:
- 11768
- H9B-MC-BCDI
- CTRI/2009/091/000765
First Posted:
Feb 5, 2009
Last Update Posted:
Apr 25, 2018
Last Verified:
Mar 1, 2018
Keywords provided by Eli Lilly and Company
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | After ≥3 months treatment, investigator could choose 1-time dose increase [120 milligrams (mg) LY2127399 (LY)] for participants (pts) with ≥4 tender and ≥4 swollen joints. Additionally, 1-time dose decrease back to 60 mg LY permitted. Pts completing Week 72 completed study, but could be followed beyond Week 72 for B cell recovery (up to Week 112). |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 |
|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). |
| Period Title: Overall Study | |||
| STARTED | 60 | 121 | 1 |
| Received Any Amount of Study Drug | 60 | 121 | 1 |
| Had at Least 1 Efficacy Assessment | 59 | 121 | 1 |
| Included in Efficacy Analyses | 59 | 120 | 1 |
| COMPLETED | 53 | 87 | 0 |
| NOT COMPLETED | 7 | 34 | 1 |
Baseline Characteristics
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 | Total |
|---|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). | Total of all reporting groups |
| Overall Participants | 59 | 121 | 1 | 181 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
53.4
(11.86)
|
51.5
(12.20)
|
61.5
(NA)
|
52.2
(12.08)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
50
84.7%
|
99
81.8%
|
1
100%
|
150
82.9%
|
| Male |
9
15.3%
|
22
18.2%
|
0
0%
|
31
17.1%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| White |
34
57.6%
|
80
66.1%
|
1
100%
|
115
63.5%
|
| Black or African American |
1
1.7%
|
12
9.9%
|
0
0%
|
13
7.2%
|
| Hispanic |
19
32.2%
|
24
19.8%
|
0
0%
|
43
23.8%
|
| East Asian |
5
8.5%
|
4
3.3%
|
0
0%
|
9
5%
|
| West Asian |
0
0%
|
1
0.8%
|
0
0%
|
1
0.6%
|
| Region of Enrollment (Count of Participants) | ||||
| Austria |
3
5.1%
|
3
2.5%
|
0
0%
|
6
3.3%
|
| Australia |
1
1.7%
|
0
0%
|
0
0%
|
1
0.6%
|
| Belgium |
0
0%
|
1
0.8%
|
0
0%
|
1
0.6%
|
| Brazil |
4
6.8%
|
9
7.4%
|
0
0%
|
13
7.2%
|
| Canada |
0
0%
|
4
3.3%
|
0
0%
|
4
2.2%
|
| Chile |
5
8.5%
|
8
6.6%
|
0
0%
|
13
7.2%
|
| Germany |
1
1.7%
|
1
0.8%
|
0
0%
|
2
1.1%
|
| Hungary |
6
10.2%
|
6
5%
|
0
0%
|
12
6.6%
|
| India |
5
8.5%
|
4
3.3%
|
0
0%
|
9
5%
|
| Mexico |
12
20.3%
|
12
9.9%
|
0
0%
|
24
13.3%
|
| Poland |
12
20.3%
|
30
24.8%
|
0
0%
|
42
23.2%
|
| Puerto Rico |
0
0%
|
1
0.8%
|
0
0%
|
1
0.6%
|
| Romania |
3
5.1%
|
3
2.5%
|
0
0%
|
6
3.3%
|
| United States |
7
11.9%
|
39
32.2%
|
1
100%
|
47
26%
|
Outcome Measures
| Title | Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
|---|---|
| Description | A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module. Participants were on treatment up to 48 weeks. If a participant completed 48 weeks of treatment, the post-study treatment follow-up started at the next visit, 4 weeks later (Week 52). If a participant discontinued treatment early [early discontinuation (ED)], the post-study treatment follow-up started immediately afterwards. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. |
| Time Frame | Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug. |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 |
|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). |
| Measure Participants | 60 | 121 | 1 |
| Any TEAE |
38
64.4%
|
95
78.5%
|
1
100%
|
| Any SAE |
4
6.8%
|
16
13.2%
|
1
100%
|
| Title | Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs |
|---|---|
| Description | For each planned laboratory evaluation, the range of values to be reported as AEs, regardless of causality, was pre-specified. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. |
| Time Frame | Baseline through Week 112 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug. |
| Arm/Group Title | 60 mg LY2127399 Treatment | 60/120 mg LY2127399 Treatment | 60/120/60 mg LY2127399 Treatment | 60 mg LY2127399 Post-Study Treatment Follow-Up | 60/120 mg LY2127399 Post-Study Treatment Follow-Up | 60/120/60 mg LY2127399 Post-Study Treatment Follow-Up |
|---|---|---|---|---|---|---|
| Arm/Group Description | AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit). LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit). LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit). LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). | AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment. No study drug was administered during the post-study treatment follow-up. | AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment. No study drug was administered during the post-study treatment follow-up. | AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and subsequently, a dose decrease back to 60 mg LY2127399 during study treatment. No study drug was administered during the post-study treatment follow-up. |
| Measure Participants | 60 | 121 | 1 | 60 | 121 | 1 |
| Alanine Aminotransferase (ALT) Increased |
0
0%
|
1
0.8%
|
0
0%
|
0
0%
|
1
NaN
|
0
NaN
|
| Aspartate Aminotransferase (AST) Increased |
0
0%
|
1
0.8%
|
0
0%
|
0
0%
|
1
NaN
|
0
NaN
|
| B-Lymphocyte Count Decreased |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
NaN
|
0
NaN
|
| Blood Alkaline Phosphatase Increased |
0
0%
|
1
0.8%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
| Blood Cholesterol Increased |
1
1.7%
|
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
| Blood Immunoglobulin M (IgM) Increased |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
NaN
|
0
NaN
|
| Gamma-Glutamyltransferase (GGT) Increased |
0
0%
|
2
1.7%
|
0
0%
|
1
0.6%
|
0
NaN
|
0
NaN
|
| Hepatic Enzyme Increased |
0
0%
|
1
0.8%
|
0
0%
|
1
0.6%
|
0
NaN
|
0
NaN
|
| Neutrophil Count Increased |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
NaN
|
0
NaN
|
| Vitamin D Decreased |
1
1.7%
|
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
| White Blood Cell Count Increased |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
NaN
|
0
NaN
|
| Dyslipidaemia |
0
0%
|
1
0.8%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
| Hypercholesterolaemia |
0
0%
|
2
1.7%
|
1
100%
|
0
0%
|
0
NaN
|
0
NaN
|
| Hyperglycaemia |
0
0%
|
1
0.8%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
| Hyperlipidaemia |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
NaN
|
0
NaN
|
| Hypokalaemia |
0
0%
|
0
0%
|
1
100%
|
0
0%
|
1
NaN
|
0
NaN
|
| Vitamin B12 Deficiency |
0
0%
|
1
0.8%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
| Vitamin D Deficiency |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
NaN
|
0
NaN
|
| Title | Change From Baseline in Tender Joint Count [Individual Component of the American College of Rheumatology (ACR) Core Set] |
|---|---|
| Description | The number of tender and painful joints was determined by examination of 28 joints (14 on each side) which included: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. Joints were assessed by pressure and joint manipulation on physical examination. The participant was asked for pain sensations on these manipulations and the investigator watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in tender joint count indicated an improvement in the participant's condition. |
| Time Frame | Baseline, up to and through Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug and had at least 1 post-baseline tender joint assessment; excludes site with GCP issues; Last observation carried forward (LOCF). |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 |
|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). |
| Measure Participants | 59 | 120 | 1 |
| Mean (Standard Deviation) [tender joints] |
-9.2
(8.0)
|
-6.5
(8.2)
|
-12.0
(NA)
|
| Title | Change From Baseline in Swollen Joint Count (Individual Component of the ACR Core Set) |
|---|---|
| Description | The number of swollen joints was determined by examination of 28 joints (14 on each side) which included: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in swollen joint count indicated an improvement in the participant's condition. |
| Time Frame | Baseline, up to and through Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug and had at least 1 post-baseline swollen joint assessment; excludes site with GCP issues; LOCF. |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 |
|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). |
| Measure Participants | 59 | 120 | 1 |
| Mean (Standard Deviation) [swollen joints] |
-7.6
(6.8)
|
-5.3
(6.6)
|
2.0
(NA)
|
| Title | Change From Baseline in Participant's Assessment of Disease Activity (Individual Component of the ACR Core Set) |
|---|---|
| Description | Participant's assessment of their current arthritis disease activity using a visual analog scale (VAS), which ranged from 0 millimeters (mm) (no arthritis activity) to 100 mm (extremely active arthritis). Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in disease activity score indicated an improvement in the participant's condition. |
| Time Frame | Baseline, up to and through Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug and had at least 1 post-baseline self-rated assessment of disease activity; excludes site with GCP issues; LOCF. |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 |
|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). |
| Measure Participants | 57 | 117 | 1 |
| Mean (Standard Deviation) [mm] |
-26.1
(27.1)
|
-16.7
(30.7)
|
-68.0
(NA)
|
| Title | Change From Baseline in Physician's Global Assessment of Disease Activity (Individual Component of the ACR Core Set) |
|---|---|
| Description | Physician's assessment of disease activity using a VAS that ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in disease activity score indicated an improvement in the participant's condition. |
| Time Frame | Baseline, up to and through Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug and had at least 1 post-baseline physician's global assessment of disease activity; excludes site with GCP issues; LOCF. |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 |
|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). |
| Measure Participants | 58 | 120 | 1 |
| Mean (Standard Deviation) [mm] |
-29.1
(23.6)
|
-18.4
(26.9)
|
-38.0
(NA)
|
| Title | Change From Baseline in Health Assessment Questionnaire-Disability Index [(HAQ-DI) Individual Component of the ACR Core Set] |
|---|---|
| Description | The disability section of the health assessment questionnaire scored the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area, which ranged from 0 (no disability) to 3 (severe disability), were averaged to calculate HAQ-DI. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in HAQ-DI score indicated an improvement in the participant's condition. |
| Time Frame | Baseline, up to and through Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug and had at least 1 post-baseline HAQ-DI assessment; excludes site with GCP issues; LOCF. |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 |
|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). |
| Measure Participants | 59 | 118 | 1 |
| Mean (Standard Deviation) [units on a scale] |
-0.3
(0.5)
|
-0.3
(0.6)
|
-0.5
(NA)
|
| Title | Change From Baseline in Participant's Assessment of Joint Pain (Individual Component of the ACR Core Set) |
|---|---|
| Description | Participant's assessment of joint pain using a VAS, which ranged from 0 mm (no pain) to 100 mm (worst possible pain). Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in joint pain indicated an improvement in the participant's condition. |
| Time Frame | Baseline, up to and through Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug and had at least 1 post-baseline self-rated assessment of joint pain; excludes site with GCP issues; LOCF. |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 |
|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). |
| Measure Participants | 59 | 118 | 1 |
| Mean (Standard Deviation) [mm] |
-26.9
(26.4)
|
-13.4
(30.2)
|
-68.0
(NA)
|
| Title | Percent Change From Baseline in C-Reactive Protein [(CRP) Individual Component of the ACR Core Set] |
|---|---|
| Description | CRP is an indicator of inflammation. The percentage of change in CRP from baseline=[(post-baseline CRP-baseline CRP)/baseline CRP]*100. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A negative change indicated an improvement in the participant's condition. |
| Time Frame | Baseline, up to and through Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug and had at least 1 post-baseline CRP assessment; excludes site with GCP issues; LOCF. |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 |
|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). |
| Measure Participants | 58 | 120 | 1 |
| Mean (Standard Deviation) [percent change] |
-11.1
(164.6)
|
50.7
(214.4)
|
241.4
(NA)
|
| Title | Percentage of Participants Achieving ACR20 Response |
|---|---|
| Description | ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had ≥20% improvement from baseline in both tender and swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR20 response=(number of ACR20 responders/number of participants treated)*100. Participants who discontinued from study prior to Week 52 were imputed as non-responders. Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF. This composite data imputation was denoted as non-responder imputation (NRI)/LOCF. Baseline: the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. |
| Time Frame | Baseline, up to and through Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug and had at least 1 post-baseline ACR20 assessment; excludes site with GCP issues; missing data imputed by NRI/LOCF. Four (4), 29, and 1 participants were imputed as non-responders for the 60 mg, 60/120 mg, and 60/120/60 mg LY2127399 groups, respectively. |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 |
|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). |
| Measure Participants | 59 | 120 | 1 |
| Number [percentage of participants] |
66.1
112%
|
32.5
26.9%
|
0.0
0%
|
| Title | Percentage of Participants ACR50 Response |
|---|---|
| Description | ACR50 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR50 Responder: had ≥50% improvement from baseline in both tender and swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR50 response=(number of ACR50 responders/number of participants treated)*100. Participants who discontinued from study prior to Week 52 were imputed as non-responders. Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF. This composite data imputation was denoted as NRI/LOCF. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. |
| Time Frame | Baseline, up to and through Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug and had at least 1 post-baseline ACR50 assessment; excludes site with GCP issues; missing data imputed by NRI/LOCF. Four (4), 29, and 1 participants were imputed as non-responders for the 60 mg, 60/120 mg, and 60/120/60 mg LY2127399 groups, respectively. |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 |
|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). |
| Measure Participants | 59 | 120 | 1 |
| Number [percentage of participants] |
33.9
57.5%
|
13.3
11%
|
0.0
0%
|
| Title | Percentage of Participants Achieving ACR70 Response |
|---|---|
| Description | ACR70 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR70 Responder: had ≥70% improvement from baseline in both tender and swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR70 response=(number of ACR70 responders/number of participants treated)*100. Participants who discontinued from study prior to Week 52 were imputed as non-responders. Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF. This composite data imputation was denoted as NRI/LOCF. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. |
| Time Frame | Baseline, up to and through Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug and had at least 1 post-baseline ACR70 assessment; excludes site with GCP issues; missing data imputed by NRI/LOCF. Four (4), 29, and 1 participants were imputed as non-responders for the 60 mg, 60/120 mg, and 60/120/60 mg LY2127399 groups, respectively. |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 |
|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). |
| Measure Participants | 59 | 120 | 1 |
| Number [percentage of participants] |
18.6
31.5%
|
6.7
5.5%
|
0.0
0%
|
| Title | ACR-N Response |
|---|---|
| Description | The ACR-N Responder Index was a composite of clinical, laboratory, and functional measures of rheumatoid arthritis. This index was defined as the lowest of either a) percent change in tender joint count, b) percent change in swollen joint count, or c) median percent change in 5 core ACR criteria: participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. For example, a participant with an ACR-N of X had an improvement ≥X% in both tender and swollen joint counts and a median improvement ≥X% in the 5 criteria previously mentioned. Baseline was the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. Results for the 60/120/60 mg LY2127399 treatment arm were not analyzed as the participant did not have an ACR assessment. |
| Time Frame | Baseline, up to and through Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug and had at least 1 post-baseline ACR-N assessment; excludes site with GCP issues; LOCF. No participant was analyzed in the 60/120/60 mg LY2127399 treatment arm. |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 |
|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). |
| Measure Participants | 59 | 120 | 0 |
| Mean (Standard Deviation) [units on a scale] |
31.9
(47.6)
|
11.3
(46.4)
|
| Title | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score |
|---|---|
| Description | The FACIT Fatigue Scale was a brief participant-reported measure of fatigue and consisted of 13 items. Scores ranged from 0 to 52, where higher scores indicated less fatigue. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. An increase in FACIT fatigue score indicated an improvement of the participant's condition. |
| Time Frame | Baseline, up to and through Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug and had at least 1 post-baseline FACIT assessment; excludes site with GCP issues; LOCF. |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 |
|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). |
| Measure Participants | 59 | 118 | 1 |
| Mean (Standard Deviation) [units on a scale] |
5.2
(10.4)
|
5.1
(10.5)
|
-6.0
(NA)
|
| Title | Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) |
|---|---|
| Description | The DAS28 consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP (milligrams per liter [mg/L]), and participant global assessment of his or her disease activity using a VAS (participant global VAS). The DAS28 was calculated by using the following formula: DAS28-CRP=0.56*square root(TJC28)+0.28*square root(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. Scores ranged from 1.0 to 9.4 where lower scores indicated less disease activity and remission is DAS28 <2.6. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in DAS28 indicated an improvement in the participant's condition. |
| Time Frame | Baseline, up to and through Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug and had at least 1 post-baseline DAS28 assessment; excludes site with GCP issues; LOCF. |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 |
|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). |
| Measure Participants | 56 | 117 | 1 |
| Mean (Standard Deviation) [units on a scale] |
-2.0
(1.5)
|
-1.3
(1.5)
|
-1.3
(NA)
|
| Title | Percentage of Participants With Response Based on European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28) |
|---|---|
| Description | EULAR28 was defined by the participant's change from baseline in DAS28 score and the absolute DAS28 score achieved. DAS28 consisted of composite score of the following: tender joint count, swollen joint count, CRP, and participant global assessment of his\her disease activity (participant global VAS). EULAR28 categories included: No Response [improvement in DAS28 ≤0.6 units (u) or post-baseline DAS28 score >5.1 with improvement ≤1.2 u], Moderate Response (post-baseline DAS28 score ≤5.1 with improvement >0.6 u but <1.2 u or post-baseline DAS28 score >3.2 with improvement >1.2 u), and Good Response (post-baseline DAS28 score ≤3.2 with improvement >1.2 u). Baseline was the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. Percentage of participants=(number of participants with specific response/participants assessed)*100. Displayed percentages may not add up to 100% because of rounding. |
| Time Frame | Baseline, up to and through Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug and had at least 1 post-baseline EULAR28 assessment; excludes site with GCP issues; LOCF. |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 |
|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). |
| Measure Participants | 56 | 117 | 1 |
| No response |
16.1
27.3%
|
44.4
36.7%
|
0
0%
|
| Moderate response |
48.2
81.7%
|
39.3
32.5%
|
100.0
10000%
|
| Good response |
35.7
60.5%
|
16.2
13.4%
|
0
0%
|
| Title | Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores |
|---|---|
| Description | SF-36 was a 36-item, health-related survey that assessed participant's quality of life on 8 domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health, mental health, social functioning, vitality and 2 component scores (mental and physical health). Domain scores calculated by summing individual items for each domain and transforming scores into 0 to 100 scale; higher scores indicated better health status. The mental component summary (MCS) score, based on SF-36 domains, consisted of social functioning, vitality, mental health, and role-emotional scales (range: 0 to 100). The physical component summary (PCS) score, based on SF-36 domains, consisted of physical functioning, bodily pain, role-physical, and general health scales (range: 0 to 100). Baseline: last assessment prior to participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. |
| Time Frame | Baseline, up to and through Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug and had at least 1 post-baseline SF-36 assessment; excludes site with GCP issues; LOCF. |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 |
|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). |
| Measure Participants | 59 | 117 | 1 |
| Physical Health Component Summary Score |
5.7
(8.0)
|
4.1
(9.6)
|
1.4
(NA)
|
| Mental Health Component Summary Score |
4.7
(12.2)
|
2.9
(10.1)
|
-2.9
(NA)
|
| Title | Pharmacodynamics: Change From Baseline in Total B Cells [Cluster Designation 20+ (CD20+)] Absolute Cell Counts |
|---|---|
| Description | B-lymphocyte antigen CD20+ is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928). A negative change indicated a decrease in cell count. |
| Time Frame | Baseline, Weeks 52, 60, 72, 80, 88, and 100 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug and a post-baseline total B cell assessment at the specified time points. |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 |
|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). |
| Measure Participants | 53 | 83 | 1 |
| Week 52 |
-113.1
(103.4)
|
-110.3
(121.7)
|
|
| Week 60 |
-135.9
(119.0)
|
-143.1
(135.3)
|
|
| Week 72 |
-141.0
(105.4)
|
-151.6
(117.8)
|
|
| Week 80 |
-137.6
(85.7)
|
-150.9
(127.7)
|
-262.0
(NA)
|
| Week 88 |
-109.9
(83.8)
|
-148.6
(131.3)
|
-143.0
(NA)
|
| Week 100 |
-71.7
(68.7)
|
-127.3
(121.4)
|
-95.0
(NA)
|
| Title | Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts) |
|---|---|
| Description | Cell surface marker CD19, CD27, and immunoglobulin D (IgD) expression levels were used to define the various B cell subsets. Cell surface markers were defined as being either present (+) or absent (-). Peripheral blood B cell subsets included: mature naive cells (CD19+IgD+CD27-); immature/transitional cells (CD19+IgD-CD27-); switched memory (CD19+IgD-CD27+); and non-switched memory (CD19+IgD+CD27+). Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928). A negative change indicated a decrease in cell count. |
| Time Frame | Baseline, Weeks 52, 60, 72, 80, 88, and 100 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug and had the specified peripheral blood B cell subset assessment post-baseline at the specified time points. |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 |
|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). |
| Measure Participants | 52 | 82 | 1 |
| Mature Naive Cells, Week 52 |
-115.0
(79.9)
|
-109.2
(92.2)
|
|
| Mature Naive Cells, Week 60 |
-138.8
(67.1)
|
||
| Mature Naive Cells, Week 72 |
-95.9
(75.4)
|
-102.6
(90.4)
|
|
| Mature Naive Cells, Week 80 |
-189.0
(NA)
|
-80.1
(62.8)
|
-123.0
(NA)
|
| Mature Naive Cells, Week 88 |
-116.5
(99.7)
|
-111.7
(75.5)
|
|
| Mature Naive Cells, Week 100 |
-89.0
(108.9)
|
||
| Immature/Transitional Cells, Week 52 |
-5.8
(7.10)
|
-4.5
(13.2)
|
|
| Immature/Transitional Cells, Week 60 |
-6.5
(7.9)
|
||
| Immature/Transitional Cells, Week 72 |
-8.6
(8.9)
|
-8.5
(15.5)
|
|
| Immature/Transitional Cells, Week 80 |
-5.0
(NA)
|
-9.0
(12.1)
|
-10.0
(NA)
|
| Immature/Transitional Cells, Week 88 |
-3.0
(4.2)
|
-9.0
(10.5)
|
|
| Immature/Transitional Cells, Week 100 |
-6.5
(0.7)
|
||
| Switched Memory Cells, Week 52 |
12.6
(27.1)
|
13.1
(31.4)
|
|
| Switched Memory Cells, Week 60 |
-6.5
(16.3)
|
||
| Switched Memory Cells, Week 72 |
-14.7
(18.9)
|
-17.7
(36.1)
|
|
| Switched Memory Cells, Week 80 |
-10.0
(NA)
|
-7.5
(17.3)
|
-23.0
(NA)
|
| Switched Memory Cells, Week 88 |
-10.0
(5.7)
|
-9.0
(10.2)
|
|
| Switched Memory Cells, Week 100 |
-13.0
(22.6)
|
||
| Non-Switched Memory Cells, Week 52 |
6.0
(22.0)
|
8.3
(22.2)
|
|
| Non-Switched Memory Cells, Week 60 |
-3.8
(2.2)
|
||
| Non-Switched Memory Cells, Week 72 |
-10.5
(18.0)
|
-7.3
(18.7)
|
|
| Non-Switched Memory Cells, Week 80 |
-4.0
(NA)
|
-3.6
(4.3)
|
-35.0
(NA)
|
| Non-Switched Memory Cells, Week 88 |
-18.0
(17.0)
|
-8.2
(9.7)
|
|
| Non-Switched Memory Cells, Week 100 |
-10.5
(9.2)
|
| Title | Pharmacodynamics: Change From Baseline in Serum Immunoglobulin |
|---|---|
| Description | Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin A (IgA) levels are reported. Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928). A negative change indicated a decrease in immunoglobulin levels. |
| Time Frame | Baseline, up to Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug and had at least 1 post-baseline serum immunoglobulin assessment; LOCF. |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 |
|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). |
| Measure Participants | 59 | 121 | 1 |
| IgG |
-1.8
(2.1)
|
-2.0
(3.8)
|
-1.9
(NA)
|
| IgM |
-0.3
(0.4)
|
-0.3
(0.5)
|
-0.2
(NA)
|
| IgA |
-0.6
(0.8)
|
-0.5
(0.7)
|
-0.8
(NA)
|
| Title | Number of Participants Who Died, Any Cause |
|---|---|
| Description | A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. Participants were on treatment up to 48 weeks. If a participant completed 48 weeks of treatment, the post-study treatment follow-up started at the next visit, 4 weeks later (Week 52). If a participant discontinued treatment early, the post-study treatment follow-up started immediately afterwards. After treatment discontinuation, participants could be followed beyond Week 72 for B cell recovery (up to Week 112). |
| Time Frame | Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post-study treatment follow-up (start of Week 53 or ED up to and through Week 72 and start of Week 73 up to and through Week 112) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug. |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 |
|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). |
| Measure Participants | 60 | 121 | 1 |
| Died on study treatment [up to Week (Wk) 52] |
0
0%
|
1
0.8%
|
0
0%
|
| Died post-study treatment Wk 53/ED through Wk 72 |
1
1.7%
|
0
0%
|
0
0%
|
| Died post-study treatment Wk 73 through Wk 100 |
1
1.7%
|
1
0.8%
|
0
0%
|
| Title | Pharmacodynamics: Change From Baseline in Rheumatoid Factor (RF) Levels at Week 52 |
|---|---|
| Description | RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. Higher RF levels indicate an aggressive rheumatoid arthritis and a higher risk of joint damage. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. A decrease in RF levels indicated an improvement in the participant's condition. Results for the 60/120/60 mg LY2127399 treatment arm were not analyzed as the participant did not have a Week 52 RF level assessment. |
| Time Frame | Baseline, Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug and had Week 52 post-baseline RF level assessment, excluding the site with GCP issues. No participant was analyzed in the 60/120/60 mg LY2127399 treatment arm. |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 |
|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). |
| Measure Participants | 50 | 87 |
| Mean (Standard Deviation) [international units/milliliter (IU/mL)] |
-26.9
(241.4)
|
-53.8
(312.6)
|
| Title | Pharmacodynamics: Change From Baseline in Serum Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies |
|---|---|
| Description | Anti-CCP antibodies were measured using an enzyme-linked immunosorbent assay (ELISA) method. In general, high levels of the antibody indicated an aggressive rheumatoid arthritis and a higher risk of joint damage. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. A decrease in anti-CCP antibodies indicated an improvement in the participant's condition. |
| Time Frame | Baseline, up to Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug and had at least 1 post-baseline anti-CCP assessment, excluding site with GCP issues; LOCF. |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 |
|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). |
| Measure Participants | 52 | 113 | 1 |
| Mean (Standard Deviation) [units per milliliter (U/mL)] |
6.9
(241.9)
|
-19.4
(358.7)
|
0.0
(NA)
|
| Title | Pharmacodynamics: Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR) |
|---|---|
| Description | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. Normal range was considered to be 0 to 20 or 0 to 30 millimeters per hour (mm/h), depending on the reference range used by the laboratory. Higher scores indicated greater inflammation. Percent change from baseline ESR=[(post-baseline ESR- baseline ESR)/baseline ESR]*100. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. A decrease in ESR indicated an improvement in the participant's condition. |
| Time Frame | Baseline, up to Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug and had at least 1 post-baseline ESR assessment, excluding site with GCP issues; LOCF. |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 |
|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). |
| Measure Participants | 57 | 116 | 1 |
| Mean (Standard Deviation) [percent change] |
5.0
(63.7)
|
20.9
(103.9)
|
-25.0
(NA)
|
| Title | Number of Participants With LY2127399 Immunogenicity (Anti-LY2127399 Antibodies) |
|---|---|
| Description | The number of participants who had treatment-emergent or follow-up emergent anti-LY2127399 antibodies [anti-drug antibodies (ADA)] is reported. Treatment-emergent was defined as participants who had any sample from baseline through Week 52 that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Follow-up emergent was defined as any sample during follow-up that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer. The number of participants with baseline positive ADA data is also reported. Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928). |
| Time Frame | Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post-study treatment follow-up (start of Week 53 or ED up to and through Week 112) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received any amount of study drug. |
| Arm/Group Title | 60 mg LY2127399 | 60/120 mg LY2127399 | 60/120/60 mg LY2127399 |
|---|---|---|---|
| Arm/Group Description | LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). |
| Measure Participants | 60 | 121 | 1 |
| Baseline Positive ADA |
2
3.4%
|
1
0.8%
|
0
0%
|
| Treatment-Emergent ADA |
6
10.2%
|
15
12.4%
|
0
0%
|
| Follow-Up Emergent ADA |
2
3.4%
|
5
4.1%
|
0
0%
|
Adverse Events
| Time Frame | Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post treatment follow-up (start of Week 53 or ED up to and through Week 112) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Participants (pt) treated up to 48 weeks (wks). If pt completed 48 wks of treatment, post-study treatment follow-up started next visit, 4 wks later (Wk 52). If pt discontinued treatment early, post-study treatment follow-up started immediately afterwards. After treatment discontinuation, pts followed beyond Wk 72 for B cell recovery (up to Wk 112). | |||||||||||
| Arm/Group Title | 60 mg LY2127399 Treatment | 60/120 mg LY2127399 Treatment | 60/120/60 mg LY2127399 Treatment | 60 mg LY2127399 Post-Study Treatment Follow-Up | 60/120 mg LY2127399 Post-Study Treatment Follow-Up | 60/120/60 mg LY2127399 Post-Study Treatment Follow-Up | ||||||
| Arm/Group Description | AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit). LY2127399: 60 mg subcutaneous injections every 4 weeks for 48 weeks. | AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit). LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, participants had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Participants remained at this dose level for the remainder of study treatment (48 weeks in total). | AEs reported while on study treatment (baseline up to Week 48) plus up to 3 weeks after discontinuation of study treatment (until next study visit). LY2127399: 60 mg subcutaneous injections every 4 weeks. After at least 3 months of treatment, the participant had a dose increase to 120 mg LY2127399, administered once every 4 weeks. Subsequently, the participant had a dose decrease back to 60 mg LY2127399, administered once every 4 weeks for the remainder of study treatment (48 weeks in total). | AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who received only the 60 mg LY2127399 dose during study treatment. No study drug was administered during the post-study treatment follow-up. | AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 during study treatment. No study drug was administered during the post-study treatment follow-up. | AEs that started or worsened after discontinuation of study treatment (Week 52 or ED) through end of study (Week 72) plus 28 weeks, for participants who had a dose increase to 120 mg LY2127399 and a dose decrease back to 60 mg LY2127399 during study treatment. No study drug was administered during the post-study treatment follow-up. | ||||||
All Cause Mortality |
||||||||||||
| 60 mg LY2127399 Treatment | 60/120 mg LY2127399 Treatment | 60/120/60 mg LY2127399 Treatment | 60 mg LY2127399 Post-Study Treatment Follow-Up | 60/120 mg LY2127399 Post-Study Treatment Follow-Up | 60/120/60 mg LY2127399 Post-Study Treatment Follow-Up | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||
Serious Adverse Events |
||||||||||||
| 60 mg LY2127399 Treatment | 60/120 mg LY2127399 Treatment | 60/120/60 mg LY2127399 Treatment | 60 mg LY2127399 Post-Study Treatment Follow-Up | 60/120 mg LY2127399 Post-Study Treatment Follow-Up | 60/120/60 mg LY2127399 Post-Study Treatment Follow-Up | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/60 (6.7%) | 16/121 (13.2%) | 1/1 (100%) | 5/60 (8.3%) | 4/121 (3.3%) | 0/1 (0%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| PANCYTOPENIA | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 1/1 (100%) | 1 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| Cardiac disorders | ||||||||||||
| HYPERTROPHIC CARDIOMYOPATHY | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| MYOCARDIAL INFARCTION | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| MYOCARDIAL ISCHAEMIA | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||
| GASTRIC ULCER | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| PANCREATITIS ACUTE | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| General disorders | ||||||||||||
| DEVICE DISLOCATION | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| Infections and infestations | ||||||||||||
| GASTROENTERITIS VIRAL | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| HEPATITIS A | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| INTERVERTEBRAL DISCITIS | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| OSTEOMYELITIS | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| PNEUMONIA | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| PNEUMONIA NECROTISING | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| PSOAS ABSCESS | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||
| BRAIN CONTUSION | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| FALL | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| POST PROCEDURAL HAEMORRHAGE | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| RIB FRACTURE | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| TRACHEAL OBSTRUCTION | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||
| DIABETIC KETOACIDOSIS | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||
| OSTEONECROSIS | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| RHEUMATOID ARTHRITIS | 1/60 (1.7%) | 1 | 4/121 (3.3%) | 4 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| BENIGN LUNG NEOPLASM | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| BREAST CANCER | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| COLON CANCER METASTATIC | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| OVARIAN EPITHELIAL CANCER | 0/51 (0%) | 0 | 0/99 (0%) | 0 | 0/1 (0%) | 0 | 1/51 (2%) | 1 | 0/99 (0%) | 0 | 0/1 (0%) | 0 |
| Nervous system disorders | ||||||||||||
| CEREBROVASCULAR ACCIDENT | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| ISCHAEMIC STROKE | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 1/1 (100%) | 1 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| ASTHMA | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| PULMONARY FIBROSIS | 0/60 (0%) | 0 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| RESPIRATORY FAILURE | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| RHEUMATOID LUNG | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| Vascular disorders | ||||||||||||
| ARTERIOSCLEROSIS | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||
| 60 mg LY2127399 Treatment | 60/120 mg LY2127399 Treatment | 60/120/60 mg LY2127399 Treatment | 60 mg LY2127399 Post-Study Treatment Follow-Up | 60/120 mg LY2127399 Post-Study Treatment Follow-Up | 60/120/60 mg LY2127399 Post-Study Treatment Follow-Up | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 36/60 (60%) | 93/121 (76.9%) | 1/1 (100%) | 23/60 (38.3%) | 47/121 (38.8%) | 0/1 (0%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| ANAEMIA | 2/60 (3.3%) | 2 | 7/121 (5.8%) | 7 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| IRON DEFICIENCY ANAEMIA | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| LEUKOCYTOSIS | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| LYMPHADENOPATHY | 0/60 (0%) | 0 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| MICROCYTIC ANAEMIA | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| THROMBOCYTOPENIA | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| Cardiac disorders | ||||||||||||
| BUNDLE BRANCH BLOCK LEFT | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| CORONARY ARTERY DISEASE | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| MYOCARDIAL ISCHAEMIA | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| PALPITATIONS | 2/60 (3.3%) | 2 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| SPLINTER HAEMORRHAGES | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| TACHYCARDIA | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| VENTRICULAR EXTRASYSTOLES | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| Ear and labyrinth disorders | ||||||||||||
| CERUMEN IMPACTION | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| EXTERNAL EAR INFLAMMATION | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| TYMPANIC MEMBRANE PERFORATION | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| VERTIGO | 0/60 (0%) | 0 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| Endocrine disorders | ||||||||||||
| HYPOTHYROIDISM | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| Eye disorders | ||||||||||||
| CATARACT | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| CONJUNCTIVAL HAEMORRHAGE | 2/60 (3.3%) | 2 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| CONJUNCTIVITIS | 1/60 (1.7%) | 1 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| OPEN ANGLE GLAUCOMA | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| RETINAL DETACHMENT | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| ULCERATIVE KERATITIS | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||
| ABDOMINAL PAIN | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| ABDOMINAL PAIN UPPER | 2/60 (3.3%) | 2 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| ABDOMINAL TENDERNESS | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| CONSTIPATION | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| DENTAL CARIES | 2/60 (3.3%) | 2 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| DIARRHOEA | 1/60 (1.7%) | 1 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 2/60 (3.3%) | 2 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| DYSPEPSIA | 0/60 (0%) | 0 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| DYSPHAGIA | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| GASTRITIS | 0/60 (0%) | 0 | 3/121 (2.5%) | 3 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| GASTROOESOPHAGEAL REFLUX DISEASE | 1/60 (1.7%) | 1 | 1/121 (0.8%) | 1 | 1/1 (100%) | 1 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| IRRITABLE BOWEL SYNDROME | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| MOUTH ULCERATION | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 1/1 (100%) | 1 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| NAUSEA | 1/60 (1.7%) | 1 | 1/121 (0.8%) | 1 | 1/1 (100%) | 1 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| ORAL MUCOSAL ERUPTION | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| PANCREATITIS | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| SALIVARY GLAND ENLARGEMENT | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| UMBILICAL HERNIA | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| VOMITING | 1/60 (1.7%) | 1 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| General disorders | ||||||||||||
| ASTHENIA | 0/60 (0%) | 0 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| CHEST PAIN | 0/60 (0%) | 0 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| DRUG INTOLERANCE | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| FATIGUE | 1/60 (1.7%) | 1 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| INJECTION SITE HAEMORRHAGE | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| INJECTION SITE NODULE | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| INJECTION SITE PAIN | 2/60 (3.3%) | 2 | 12/121 (9.9%) | 12 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| INJECTION SITE PARAESTHESIA | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| INJECTION SITE RASH | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| MALAISE | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| OEDEMA PERIPHERAL | 0/60 (0%) | 0 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| PYREXIA | 1/60 (1.7%) | 1 | 4/121 (3.3%) | 4 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| Hepatobiliary disorders | ||||||||||||
| CHOLELITHIASIS | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| CHOLESTASIS | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| Immune system disorders | ||||||||||||
| DRUG HYPERSENSITIVITY | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| Infections and infestations | ||||||||||||
| ABSCESS LIMB | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| BRONCHIOLITIS | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| BRONCHITIS | 6/60 (10%) | 7 | 8/121 (6.6%) | 8 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| CELLULITIS | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| CONJUNCTIVITIS BACTERIAL | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| CYSTITIS | 1/60 (1.7%) | 1 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| FUNGAL SKIN INFECTION | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| GASTROENTERITIS | 2/60 (3.3%) | 2 | 3/121 (2.5%) | 3 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| GASTROENTERITIS VIRAL | 0/60 (0%) | 0 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| GASTROINTESTINAL INFECTION | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| HERPES ZOSTER | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| HORDEOLUM | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| INFECTED BITES | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| INFLUENZA | 2/60 (3.3%) | 2 | 4/121 (3.3%) | 4 | 0/1 (0%) | 0 | 2/60 (3.3%) | 2 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| LABYRINTHITIS | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| LARYNGITIS | 1/60 (1.7%) | 1 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| NASOPHARYNGITIS | 5/60 (8.3%) | 5 | 9/121 (7.4%) | 9 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 |
| ORAL HERPES | 0/60 (0%) | 0 | 4/121 (3.3%) | 4 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| OTITIS MEDIA | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 |
| PHARYNGITIS | 3/60 (5%) | 3 | 5/121 (4.1%) | 6 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| PHARYNGITIS BACTERIAL | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| PHARYNGOTONSILLITIS | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| PNEUMONIA | 1/60 (1.7%) | 1 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| RESPIRATORY TRACT INFECTION | 0/60 (0%) | 0 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| RHINITIS | 1/60 (1.7%) | 1 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| SIALOADENITIS | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| SINUSITIS | 2/60 (3.3%) | 2 | 3/121 (2.5%) | 3 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 3/121 (2.5%) | 3 | 0/1 (0%) | 0 |
| SKIN INFECTION | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| SOFT TISSUE INFECTION | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| STAPHYLOCOCCAL INFECTION | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| STAPHYLOCOCCAL PHARYNGITIS | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| STAPHYLOCOCCAL SKIN INFECTION | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| TOOTH ABSCESS | 1/60 (1.7%) | 1 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| TOOTH INFECTION | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| TRACHEITIS | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| UPPER RESPIRATORY TRACT INFECTION | 2/60 (3.3%) | 2 | 12/121 (9.9%) | 12 | 0/1 (0%) | 0 | 2/60 (3.3%) | 2 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 |
| URINARY TRACT INFECTION | 2/60 (3.3%) | 2 | 13/121 (10.7%) | 13 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 3/121 (2.5%) | 3 | 0/1 (0%) | 0 |
| VAGINAL ABSCESS | 0/51 (0%) | 0 | 0/99 (0%) | 0 | 0/1 (0%) | 0 | 0/51 (0%) | 0 | 1/99 (1%) | 1 | 0/1 (0%) | 0 |
| VAGINAL INFECTION | 0/51 (0%) | 0 | 1/99 (1%) | 1 | 0/1 (0%) | 0 | 0/51 (0%) | 0 | 0/99 (0%) | 0 | 0/1 (0%) | 0 |
| VIRAL INFECTION | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | 1/60 (1.7%) | 1 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| VULVOVAGINAL MYCOTIC INFECTION | 1/51 (2%) | 1 | 1/99 (1%) | 1 | 0/1 (0%) | 0 | 0/51 (0%) | 0 | 0/99 (0%) | 0 | 0/1 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||
| ANAEMIA POSTOPERATIVE | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| ANIMAL BITE | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| ANKLE FRACTURE | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| CONTUSION | 1/60 (1.7%) | 1 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| DRUG EXPOSURE DURING PREGNANCY | 0/51 (0%) | 0 | 1/99 (1%) | 1 | 0/1 (0%) | 0 | 0/51 (0%) | 0 | 0/99 (0%) | 0 | 0/1 (0%) | 0 |
| EPICONDYLITIS | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| EXCORIATION | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| FACIAL BONES FRACTURE | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| FALL | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| FIBULA FRACTURE | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| FOOT FRACTURE | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| JOINT SPRAIN | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| LACERATION | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| LIMB INJURY | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| MUSCLE RUPTURE | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| MUSCLE STRAIN | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| NAIL INJURY | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| RADIUS FRACTURE | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| TENDON INJURY | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| TENDON RUPTURE | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| THERMAL BURN | 1/60 (1.7%) | 1 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| TOOTH FRACTURE | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| Investigations | ||||||||||||
| ALANINE AMINOTRANSFERASE INCREASED | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| ASPARTATE AMINOTRANSFERASE INCREASED | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| ASPIRATION JOINT | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| ASPIRATION PLEURAL CAVITY | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| B-LYMPHOCYTE COUNT DECREASED | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| BLOOD ALKALINE PHOSPHATASE INCREASED | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| BLOOD CHOLESTEROL INCREASED | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| BLOOD IMMUNOGLOBULIN M INCREASED | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| BLOOD PRESSURE INCREASED | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| BODY TEMPERATURE INCREASED | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| ECG SIGNS OF VENTRICULAR HYPERTROPHY | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| ELECTROCARDIOGRAM ST SEGMENT ABNORMAL | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | 0/60 (0%) | 0 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| HEART RATE INCREASED | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| HEPATIC ENZYME INCREASED | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| NEUTROPHIL COUNT INCREASED | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| QRS AXIS ABNORMAL | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| VITAMIN D DECREASED | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| WEIGHT DECREASED | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| WEIGHT INCREASED | 1/60 (1.7%) | 1 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| WHITE BLOOD CELL COUNT INCREASED | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||
| DIABETES MELLITUS | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 1/1 (100%) | 1 | 1/60 (1.7%) | 1 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 |
| DYSLIPIDAEMIA | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| GOUT | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| HYPERCHOLESTEROLAEMIA | 0/60 (0%) | 0 | 2/121 (1.7%) | 2 | 1/1 (100%) | 1 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| HYPERGLYCAEMIA | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| HYPERLIPIDAEMIA | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| HYPOKALAEMIA | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 1/1 (100%) | 1 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| VITAMIN B12 DEFICIENCY | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| VITAMIN D DEFICIENCY | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||
| ARTHRALGIA | 2/60 (3.3%) | 2 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| ATLANTOAXIAL INSTABILITY | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| BACK PAIN | 2/60 (3.3%) | 2 | 5/121 (4.1%) | 5 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| BURSITIS | 1/60 (1.7%) | 1 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| ENTHESOPATHY | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| EXOSTOSIS | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| FASCIITIS | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| FIBROMYALGIA | 2/60 (3.3%) | 2 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| FOOT DEFORMITY | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| INTERVERTEBRAL DISC DEGENERATION | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| INTERVERTEBRAL DISC PROTRUSION | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| MUSCLE SPASMS | 1/60 (1.7%) | 1 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| MUSCULOSKELETAL CHEST PAIN | 1/60 (1.7%) | 1 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| MUSCULOSKELETAL PAIN | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| MYOFASCIAL PAIN SYNDROME | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| OSTEOARTHRITIS | 0/60 (0%) | 0 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| OSTEOCHONDROSIS | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| OSTEOPOROSIS | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| PAIN IN EXTREMITY | 1/60 (1.7%) | 1 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| RHEUMATOID ARTHRITIS | 10/60 (16.7%) | 11 | 28/121 (23.1%) | 30 | 0/1 (0%) | 0 | 3/60 (5%) | 3 | 14/121 (11.6%) | 14 | 0/1 (0%) | 0 |
| TENDONITIS | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| BENIGN NEOPLASM OF THYROID GLAND | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| Nervous system disorders | ||||||||||||
| CARPAL TUNNEL SYNDROME | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 |
| DIZZINESS | 1/60 (1.7%) | 1 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| HEADACHE | 2/60 (3.3%) | 2 | 3/121 (2.5%) | 3 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| HYPERAESTHESIA | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| MIGRAINE | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| NEUROPATHY PERIPHERAL | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| PARAESTHESIA | 0/60 (0%) | 0 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| RADICULAR SYNDROME | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| SOMNOLENCE | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| SYNCOPE | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| VASCULAR DEMENTIA | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| VITH NERVE PARALYSIS | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| Psychiatric disorders | ||||||||||||
| ANXIETY | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| DEPRESSION | 1/60 (1.7%) | 1 | 4/121 (3.3%) | 4 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| INSOMNIA | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 1/1 (100%) | 1 | 1/60 (1.7%) | 1 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||
| DYSURIA | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 1/60 (1.7%) | 2 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| NEPHROLITHIASIS | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| NEPHROPATHY | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| RENAL COLIC | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||||||
| BREAST CYST | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| MENORRHAGIA | 1/51 (2%) | 1 | 0/99 (0%) | 0 | 0/1 (0%) | 0 | 0/51 (0%) | 0 | 0/99 (0%) | 0 | 0/1 (0%) | 0 |
| METRORRHAGIA | 0/51 (0%) | 0 | 0/99 (0%) | 0 | 0/1 (0%) | 0 | 1/51 (2%) | 1 | 0/99 (0%) | 0 | 0/1 (0%) | 0 |
| POSTMENOPAUSAL HAEMORRHAGE | 0/51 (0%) | 0 | 1/99 (1%) | 1 | 0/1 (0%) | 0 | 0/51 (0%) | 0 | 0/99 (0%) | 0 | 0/1 (0%) | 0 |
| UTERINE POLYP | 0/51 (0%) | 0 | 1/99 (1%) | 1 | 0/1 (0%) | 0 | 0/51 (0%) | 0 | 0/99 (0%) | 0 | 0/1 (0%) | 0 |
| VAGINAL HAEMORRHAGE | 0/51 (0%) | 0 | 1/99 (1%) | 1 | 0/1 (0%) | 0 | 0/51 (0%) | 0 | 0/99 (0%) | 0 | 0/1 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| ALLERGIC COUGH | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| ASTHMA | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 0/60 (0%) | 0 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| COUGH | 3/60 (5%) | 3 | 3/121 (2.5%) | 3 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| DYSPHONIA | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| EMPHYSEMA | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| EPISTAXIS | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| HYDROPNEUMOTHORAX | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| PULMONARY EMBOLISM | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| RALES | 0/60 (0%) | 0 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| RHINORRHOEA | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| SINUS CONGESTION | 0/60 (0%) | 0 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||
| ACNE | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| ALOPECIA | 0/60 (0%) | 0 | 3/121 (2.5%) | 3 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| DERMATITIS | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| DERMATITIS ALLERGIC | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| DERMATOSIS | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| ECCHYMOSIS | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| ECZEMA NUMMULAR | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| ERYTHEMA | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| ERYTHEMA NODOSUM | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| HYPERKERATOSIS | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| INCREASED TENDENCY TO BRUISE | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| INGROWING NAIL | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| MACULE | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| PETECHIAE | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| RASH | 0/60 (0%) | 0 | 3/121 (2.5%) | 3 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| RASH GENERALISED | 1/60 (1.7%) | 1 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| RASH PAPULAR | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| SKIN INDURATION | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| SKIN LESION | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| SKIN ULCER | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| Surgical and medical procedures | ||||||||||||
| ARTHRODESIS | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| CATARACT OPERATION | 0/60 (0%) | 0 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| DEBRIDEMENT | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| HIP ARTHROPLASTY | 1/60 (1.7%) | 1 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| KNEE ARTHROPLASTY | 0/60 (0%) | 0 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| SYNOVECTOMY | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| TOOTH EXTRACTION | 1/60 (1.7%) | 1 | 2/121 (1.7%) | 2 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| Vascular disorders | ||||||||||||
| AORTIC ARTERIOSCLEROSIS | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| HAEMATOMA | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| HOT FLUSH | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| HYPERTENSION | 4/60 (6.7%) | 4 | 8/121 (6.6%) | 8 | 1/1 (100%) | 1 | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 |
| HYPERTENSIVE CRISIS | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| HYPOTENSION | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| PHLEBITIS SUPERFICIAL | 0/60 (0%) | 0 | 1/121 (0.8%) | 1 | 0/1 (0%) | 0 | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
| VENOUS INSUFFICIENCY | 0/60 (0%) | 0 | 0/121 (0%) | 0 | 0/1 (0%) | 0 | 1/60 (1.7%) | 1 | 0/121 (0%) | 0 | 0/1 (0%) | 0 |
Limitations/Caveats
Data integrity issues were identified at 1 study site involving 1 participant. Therefore, this site/participant is excluded from all efficacy analyses/results.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 800-545-5979 |
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00837811
Other Study ID Numbers:
- 11768
- H9B-MC-BCDI
- CTRI/2009/091/000765
First Posted:
Feb 5, 2009
Last Update Posted:
Apr 25, 2018
Last Verified:
Mar 1, 2018