ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 29 for:    LY2439821
Previous Study | Return to List | Next Study

A Study of LY2439821 in Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01236118
Recruitment Status : Completed
First Posted : November 8, 2010
Results First Posted : May 26, 2016
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Intervention Drug: LY2439821
Enrollment 28
Recruitment Details  
Pre-assignment Details Eligible participants must have completed Study I1F-JE-RHAL (NCT01253265) to meet the enrollment criteria of this study.
Arm/Group Title 30 mg LY2439821 80 mg LY2439821 160 mg LY2439821
Hide Arm/Group Description Included participants from 30 milligrams (mg) group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection once every week (Q1W) for the first 3 doses and once every 2 weeks (Q2W) until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection once every 4 weeks (Q4W) until Week 44. Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44. Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44.
Period Title: Overall Study
Started 6 5 17
Completed 4 4 14
Not Completed 2 1 3
Reason Not Completed
Adverse Event             2             0             2
Physician Decision             0             1             0
Withdrawal by Subject             0             0             1
Arm/Group Title 30 mg LY2439821 80 mg LY2439821 160 mg LY2439821 Total
Hide Arm/Group Description Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44. Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 Q1W subcutaneous injection for the first 3 doses and then Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44. Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 Q2W subcutaneous injection for the first 3 doses then Q4W until Week 44. Total of all reporting groups
Overall Number of Baseline Participants 6 5 17 28
Hide Baseline Analysis Population Description
All enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 5 participants 17 participants 28 participants
53.2  (15.0) 61.2  (8.1) 57.6  (11.4) 57.3  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 17 participants 28 participants
Female
3
  50.0%
5
 100.0%
10
  58.8%
18
  64.3%
Male
3
  50.0%
0
   0.0%
7
  41.2%
10
  35.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 17 participants 28 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
6
 100.0%
5
 100.0%
17
 100.0%
28
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian Number Analyzed 6 participants 5 participants 17 participants 28 participants
6 5 17 28
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 6 participants 5 participants 17 participants 28 participants
6 5 17 28
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 6 participants 5 participants 17 participants 28 participants
54.23  (9.69) 54.12  (7.66) 61.25  (15.55) 58.47  (13.48)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters (cm)
Number Analyzed 6 participants 5 participants 17 participants 28 participants
161.62  (9.62) 152.34  (6.20) 159.52  (8.87) 158.69  (8.90)
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms per square meter (kg/m^2)
Number Analyzed 6 participants 5 participants 17 participants 28 participants
20.68  (2.37) 23.38  (3.50) 23.95  (5.28) 23.15  (4.60)
[1]
Measure Description: BMI is an estimate of body fat based on body weight in kilograms divided by height squared in meters.
Weekly Dose of Methotrexate (MTX)  
Mean (Standard Deviation)
Unit of measure:  Milligrams per week (mg/week)
Number Analyzed 6 participants 5 participants 17 participants 28 participants
9.08  (1.86) 8.40  (0.89) 8.35  (0.79) 8.52  (1.10)
Number of Participants Given Doses in Study I1F-JE-RHAL (NCT01253265)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 17 participants 28 participants
LY2439821 4 4 14 22
Placebo 2 1 3 6
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs) [Clinically Significant Events]
Hide Description Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this report.
Time Frame Baseline through study completion (up to Week 56)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title 30 mg LY2439821 80 mg LY2439821 160 mg LY2439821
Hide Arm/Group Description:
Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 Q1W subcutaneous injection for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44.
Overall Number of Participants Analyzed 6 5 17
Measure Type: Number
Unit of Measure: participants
AEs (All Causalities) 6 5 16
AEs (Drug-Related) 3 4 7
SAEs 1 0 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 30 mg LY2439821 80 mg LY2439821 160 mg LY2439821
Hide Arm/Group Description Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44. Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44. Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44.
All-Cause Mortality
30 mg LY2439821 80 mg LY2439821 160 mg LY2439821
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
30 mg LY2439821 80 mg LY2439821 160 mg LY2439821
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/6 (16.67%)      0/5 (0.00%)      2/17 (11.76%)    
Cardiac disorders       
Acute myocardial infarction  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Infections and infestations       
Cellulitis  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Eczema infected  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Vascular disorders       
Aortic dissection  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
30 mg LY2439821 80 mg LY2439821 160 mg LY2439821
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      5/5 (100.00%)      16/17 (94.12%)    
Blood and lymphatic system disorders       
Iron deficiency anaemia  1  0/6 (0.00%)  0 1/5 (20.00%)  1 1/17 (5.88%)  1
Lymphadenopathy  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
Ear and labyrinth disorders       
Ear pain  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
Eye disorders       
Eyelid oedema  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
Gastrointestinal disorders       
Colonic polyp  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Constipation  1  1/6 (16.67%)  1 0/5 (0.00%)  0 1/17 (5.88%)  1
Crohn's disease  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Dental caries  1  0/6 (0.00%)  0 0/5 (0.00%)  0 2/17 (11.76%)  2
Diarrhoea  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Gastritis  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Gastritis atrophic  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
Gingivitis  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
Haemorrhoids  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Hiatus hernia  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
Lip swelling  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
Mouth ulceration  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Nausea  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
Reflux oesophagitis  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
Stomatitis  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
Vomiting  1  2/6 (33.33%)  2 0/5 (0.00%)  0 0/17 (0.00%)  0
General disorders       
Administration site reaction  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  13
Injection site erythema  1  1/6 (16.67%)  17 1/5 (20.00%)  11 1/17 (5.88%)  2
Injection site induration  1  0/6 (0.00%)  0 1/5 (20.00%)  1 1/17 (5.88%)  1
Oedema peripheral  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Pain  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Hepatobiliary disorders       
Hepatic function abnormal  1  0/6 (0.00%)  0 0/5 (0.00%)  0 2/17 (11.76%)  2
Hyperbilirubinaemia  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
Infections and infestations       
Bronchitis  1  0/6 (0.00%)  0 0/5 (0.00%)  0 2/17 (11.76%)  2
Gastroenteritis  1  0/6 (0.00%)  0 1/5 (20.00%)  1 0/17 (0.00%)  0
Herpes zoster  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
Influenza  1  0/6 (0.00%)  0 1/5 (20.00%)  1 0/17 (0.00%)  0
Nasopharyngitis  1  1/6 (16.67%)  1 0/5 (0.00%)  0 4/17 (23.53%)  4
Pharyngitis  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Pneumonia  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Sinusitis  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Systemic mycosis  1  0/6 (0.00%)  0 1/5 (20.00%)  1 0/17 (0.00%)  0
Tinea pedis  1  0/6 (0.00%)  0 1/5 (20.00%)  1 1/17 (5.88%)  1
Upper respiratory tract infection  1  0/6 (0.00%)  0 0/5 (0.00%)  0 2/17 (11.76%)  3
Injury, poisoning and procedural complications       
Chillblains  1  0/6 (0.00%)  0 1/5 (20.00%)  1 0/17 (0.00%)  0
Contusion  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
Rib fracture  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  2
Skeletal injury  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
Thermal burn  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
Investigations       
Alanine aminotransferase increased  1  0/6 (0.00%)  0 0/5 (0.00%)  0 2/17 (11.76%)  3
Aspartate aminotransferase increased  1  0/6 (0.00%)  0 0/5 (0.00%)  0 2/17 (11.76%)  3
Blood urea increased  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
C-reactive protein increased  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Eosinophil count increased  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  3
Hepatitis b dna assay positive  1  0/6 (0.00%)  0 1/5 (20.00%)  1 0/17 (0.00%)  0
Lymphocyte count decreased  1  1/6 (16.67%)  1 0/5 (0.00%)  0 2/17 (11.76%)  2
Oxygen saturation decreased  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Weight increased  1  0/6 (0.00%)  0 1/5 (20.00%)  1 2/17 (11.76%)  2
White blood cell count decreased  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Metabolism and nutrition disorders       
Type 2 diabetes mellitus  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Musculoskeletal and connective tissue disorders       
Back pain  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
Hand deformity  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Muscle spasms  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  2
Musculoskeletal pain  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
Myalgia  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Pain in extremity  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
Rheumatoid arthritis  1  2/6 (33.33%)  2 0/5 (0.00%)  0 4/17 (23.53%)  4
Spondylolisthesis  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Nervous system disorders       
Dizziness  1  0/6 (0.00%)  0 1/5 (20.00%)  1 0/17 (0.00%)  0
Dysgeusia  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  4
Headache  1  0/6 (0.00%)  0 1/5 (20.00%)  1 0/17 (0.00%)  0
Hypoaesthesia  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Psychiatric disorders       
Insomnia  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
Renal and urinary disorders       
Haematuria  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Respiratory, thoracic and mediastinal disorders       
Rhinitis allergic  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
Skin and subcutaneous tissue disorders       
Dermal cyst  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
Eczema  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Eczema asteatotic  1  0/6 (0.00%)  0 1/5 (20.00%)  1 1/17 (5.88%)  1
Hyperkeratosis  1  0/6 (0.00%)  0 1/5 (20.00%)  1 1/17 (5.88%)  1
Hyperkeratosis palmaris and plantaris  1  0/6 (0.00%)  0 1/5 (20.00%)  1 0/17 (0.00%)  0
Urticaria  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
Surgical and medical procedures       
Cardioversion  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Percutaneous coronary intervention  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Skin operation  1  1/6 (16.67%)  1 0/5 (0.00%)  0 0/17 (0.00%)  0
Vascular disorders       
Haematoma  1  0/6 (0.00%)  0 0/5 (0.00%)  0 1/17 (5.88%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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: NCT01236118     History of Changes
Other Study ID Numbers: 13625
I1F-JE-RHAM ( Other Identifier: Eli Lilly and Company )
First Submitted: November 4, 2010
First Posted: November 8, 2010
Results First Submitted: April 20, 2016
Results First Posted: May 26, 2016
Last Update Posted: May 26, 2016