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A Study in Participants With Rheumatoid Arthritis on Background Methotrexate Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01185353
First Posted: August 19, 2010
Last Update Posted: June 16, 2017
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.
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company
Results First Submitted: March 10, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Arthritis, Rheumatoid
Interventions: Drug: LY3009104
Drug: Placebo
Drug: Methotrexate

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This study consisted of 4 parts and a follow-up up to 28 days post the last dose of study drug.

Reporting Groups
  Description
1 Milligrams (mg) LY3009104 QD - Part A

Administered orally once daily (QD) for 12 weeks in Part A.

Methotrexate (MTX) was administered orally as background therapy.

2 mg LY3009104 QD - Parts A and B

Administered orally QD for 24 weeks in Parts A and B.

MTX was administered orally as background therapy.

4 mg LY3009104 QD - Parts A and B

Administered orally QD for 24 weeks in Parts A and B.

MTX was administered orally as background therapy.

8 mg LY3009104 QD - Parts A and B

Administered orally QD for 24 weeks in Parts A and B.

MTX was administered orally as background therapy.

Placebo QD - Part A

Placebo administered orally QD for 12 weeks in Part A.

MTX was administered orally as background therapy.

2 mg LY3009104 BID - Part B

Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 2 mg LY3009104 twice daily (BID) in Part B.

MTX was administered orally as background therapy.

4 mg LY3009104 QD - Part B

Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 4 mg LY3009104 QD in Part B.

MTX was administered orally as background therapy.

4 mg LY3009104 QD - Parts C and D

Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C.

Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C.

Participants who completed Part C continued to receive 4 mg LY3009104 QD in Part D.

MTX was administered orally as background therapy.

4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D

Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C.

Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C.

At Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.

Dose escalation criteria: ≥ 6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.

Participants who completed Part C received 4 mg LY3009104 QD in Part D.

MTX was administered orally as background therapy.

8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D

Participants who received 8 mg LY3009104 QD in Part B remained on 8 mg LY3009104 QD in Part C.

Participants who completed Part C received 4 mg LY3009104 QD in Part D.

MTX was administered orally as background therapy.


Participant Flow for 4 periods

Period 1:   Part A (Weeks 0 Through 12)
    1 Milligrams (mg) LY3009104 QD - Part A   2 mg LY3009104 QD - Parts A and B   4 mg LY3009104 QD - Parts A and B   8 mg LY3009104 QD - Parts A and B   Placebo QD - Part A   2 mg LY3009104 BID - Part B   4 mg LY3009104 QD - Part B   4 mg LY3009104 QD - Parts C and D   4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D   8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D
STARTED   49   52   52   50   98   0   0   0   0   0 
Received at Least 1 Dose of Study Drug   49   52   52   50   98   0   0   0   0   0 
COMPLETED   44   51   50   49   82   0   0   0   0   0 
NOT COMPLETED   5   1   2   1   16   0   0   0   0   0 
Adverse Event                1                1                1                1                5                0                0                0                0                0 
Entry Criteria Not Met                0                0                0                0                4                0                0                0                0                0 
Lack of Efficacy                2                0                0                0                1                0                0                0                0                0 
Physician Decision                0                0                1                0                2                0                0                0                0                0 
Protocol Violation                0                0                0                0                1                0                0                0                0                0 
Withdrawal by Subject                2                0                0                0                3                0                0                0                0                0 

Period 2:   Part B (Weeks 12 Through 24)
    1 Milligrams (mg) LY3009104 QD - Part A   2 mg LY3009104 QD - Parts A and B   4 mg LY3009104 QD - Parts A and B   8 mg LY3009104 QD - Parts A and B   Placebo QD - Part A   2 mg LY3009104 BID - Part B   4 mg LY3009104 QD - Part B   4 mg LY3009104 QD - Parts C and D   4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D   8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D
STARTED   0   51   50   49   0   63   63   0   0   0 
COMPLETED   0   50   48   45   0   59   57   0   0   0 
NOT COMPLETED   0   1   2   4   0   4   6   0   0   0 
Adverse Event                0                0                1                0                0                1                0                0                0                0 
Lack of Efficacy                0                1                0                1                0                0                0                0                0                0 
Lost to Follow-up                0                0                0                1                0                0                1                0                0                0 
Withdrawal by Subject                0                0                1                2                0                3                4                0                0                0 
Entry Criteria Not Met                0                0                0                0                0                0                1                0                0                0 

Period 3:   Part C (Weeks 24 Through 76)
    1 Milligrams (mg) LY3009104 QD - Part A   2 mg LY3009104 QD - Parts A and B   4 mg LY3009104 QD - Parts A and B   8 mg LY3009104 QD - Parts A and B   Placebo QD - Part A   2 mg LY3009104 BID - Part B   4 mg LY3009104 QD - Part B   4 mg LY3009104 QD - Parts C and D   4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D   8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D
STARTED   0   0   0   0   0   0   0   108   61   32 
COMPLETED   0   0   0   0   0   0   0   92   53   24 
NOT COMPLETED   0   0   0   0   0   0   0   16   8   8 
Adverse Event                0                0                0                0                0                0                0                8                2                2 
Withdrawal by Subject                0                0                0                0                0                0                0                6                2                2 
Lost to Follow-up                0                0                0                0                0                0                0                2                1                1 
Lack of Efficacy                0                0                0                0                0                0                0                0                2                0 
Death                0                0                0                0                0                0                0                0                0                1 
Entry Criteria Not Met                0                0                0                0                0                0                0                0                0                1 
Physician Decision                0                0                0                0                0                0                0                0                0                1 
Reason missing                0                0                0                0                0                0                0                0                1                0 

Period 4:   Part D (Weeks 76 Through 128)
    1 Milligrams (mg) LY3009104 QD - Part A   2 mg LY3009104 QD - Parts A and B   4 mg LY3009104 QD - Parts A and B   8 mg LY3009104 QD - Parts A and B   Placebo QD - Part A   2 mg LY3009104 BID - Part B   4 mg LY3009104 QD - Part B   4 mg LY3009104 QD - Parts C and D   4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D   8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D
STARTED   0   0   0   0   0   0   0   79   47   18 
COMPLETED   0   0   0   0   0   0   0   76   40   17 
NOT COMPLETED   0   0   0   0   0   0   0   3   7   1 
Lost to Follow-up                0                0                0                0                0                0                0                1                3                0 
Withdrawal by Subject                0                0                0                0                0                0                0                1                2                1 
Adverse Event                0                0                0                0                0                0                0                1                2                0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least 1 dose of study drug.

Reporting Groups
  Description
1 mg LY3009104

Administered orally QD for initial 12 weeks (Part A) followed by randomization to either 4 mg QD or 2 mg BID for an additional 12 weeks (Part B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.

MTX was administered orally as background therapy.

2 mg LY3009104

Administered orally QD for 24 weeks (Parts A and B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.

MTX was administered orally as background therapy.

4 mg LY3009104

Administered orally QD for 24 weeks (Parts A and B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.

MTX was administered orally as background therapy.

8 mg LY3009104

Administered orally QD for 24 weeks (Parts A and B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.

MTX was administered orally as background therapy.

Placebo

Placebo administered orally QD for initial 12 weeks (Part A) followed by randomization to either 4 mg QD or 2 mg BID for an additional 12 weeks (Part B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.

MTX was administered orally as background therapy.

Total Total of all reporting groups

Baseline Measures
   1 mg LY3009104   2 mg LY3009104   4 mg LY3009104   8 mg LY3009104   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 49   52   52   50   98   301 
Age 
[Units: Years]
Mean (Standard Deviation)
           
Participants Analyzed 
[Units: Participants]
 49   52   52   50   98   301 
   53.1  (11.07)   50.7  (13.12)   52.5  (10.42)   52.7  (10.91)   49.2  (12.15)   51.2  (11.71) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Participants Analyzed 
[Units: Participants]
 49   52   52   50   98   301 
Female      42  85.7%      44  84.6%      37  71.2%      41  82.0%      85  86.7%      249  82.7% 
Male      7  14.3%      8  15.4%      15  28.8%      9  18.0%      13  13.3%      52  17.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
           
Participants Analyzed 
[Units: Participants]
 49   52   52   50   98   301 
Hispanic or Latino      10  20.4%      7  13.5%      12  23.1%      11  22.0%      16  16.3%      56  18.6% 
Not Hispanic or Latino      36  73.5%      41  78.8%      36  69.2%      36  72.0%      78  79.6%      227  75.4% 
Unknown or Not Reported      3   6.1%      4   7.7%      4   7.7%      3   6.0%      4   4.1%      18   6.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
           
Participants Analyzed 
[Units: Participants]
 49   52   52   50   98   301 
American Indian or Alaska Native      4   8.2%      3   5.8%      3   5.8%      2   4.0%      7   7.1%      19   6.3% 
Asian      8  16.3%      8  15.4%      7  13.5%      9  18.0%      15  15.3%      47  15.6% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      1   1.9%      2   3.8%      2   4.0%      6   6.1%      11   3.7% 
White      37  75.5%      40  76.9%      40  76.9%      37  74.0%      70  71.4%      224  74.4% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
           
United States             
Participants Analyzed 
[Units: Participants]
 49   52   52   50   98   301 
United States   16   16   16   16   31   95 
Hungary             
Participants Analyzed 
[Units: Participants]
 49   52   52   50   98   301 
Hungary   3   3   3   2   2   13 
Czech Republic             
Participants Analyzed 
[Units: Participants]
 49   52   52   50   98   301 
Czech Republic   4   3   6   3   7   23 
Mexico             
Participants Analyzed 
[Units: Participants]
 49   52   52   50   98   301 
Mexico   7   8   8   8   16   47 
Poland             
Participants Analyzed 
[Units: Participants]
 49   52   52   50   98   301 
Poland   4   5   6   7   11   33 
Ukraine             
Participants Analyzed 
[Units: Participants]
 49   52   52   50   98   301 
Ukraine   6   6   5   3   9   29 
Croatia             
Participants Analyzed 
[Units: Participants]
 49   52   52   50   98   301 
Croatia   0   1   0   1   5   7 
Romania             
Participants Analyzed 
[Units: Participants]
 49   52   52   50   98   301 
Romania   2   2   1   3   3   11 
India             
Participants Analyzed 
[Units: Participants]
 49   52   52   50   98   301 
India   7   8   7   7   14   43 
Duration of Rheumatoid Arthritis 
[Units: Years]
Mean (Standard Deviation)
           
Participants Analyzed 
[Units: Participants]
 49   52   52   50   98   301 
   5.45  (3.885)   5.53  (4.377)   5.28  (4.466)   6.63  (5.048)   5.40  (4.283)   5.62  (4.401) 
Tender Joint Counts (TJC) [1] 
[Units: Number of joints]
Mean (Standard Deviation)
           
Participants Analyzed 
[Units: Participants]
 49   52   52   50   98   301 
   21.4  (10.90)   23.0  (12.60)   19.9  (12.71)   24.4  (13.76)   22.2  (12.06)   22.2  (12.38) 
[1] TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy.
Swollen Joint Counts (SJC) [1] 
[Units: Number of joints]
Mean (Standard Deviation)
           
Participants Analyzed 
[Units: Participants]
 49   52   52   50   98   301 
   15.2  (6.55)   17.0  (9.32)   14.8  (7.54)   16.1  (7.92)   15.8  (8.64)   15.8  (8.13) 
[1] SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint.
High Sensitivity C-Reactive Protein (hsCRP) [1] [2] 
[Units: Milligrams/liter (mg/L)]
Mean (Standard Deviation)
           
Participants Analyzed 
[Units: Participants]
 49   52   52   50   97   300 
   11.22  (12.410)   12.02  (22.111)   11.39  (16.941)   14.32  (15.602)   14.03  (23.527)   12.81  (19.402) 
[1] HsCRP is a laboratory analyte that is an indicator of inflammation. Decreases in hsCRP represent reductions in inflammation.
[2] All randomized participants who received at least one dose of study drug and had evaluable hsCRP data at baseline.
Erythrocyte Sedimentation Rate (ESR) [1] 
[Units: Millimeters/hour (mm/hr)]
Mean (Standard Deviation)
           
Participants Analyzed 
[Units: Participants]
 49   52   52   50   98   301 
   38.2  (17.57)   36.5  (14.62)   35.4  (17.16)   43.3  (18.17)   39.9  (20.94)   38.8  (18.39) 
[1] ESR is a laboratory analyte that is an indicator of inflammation. Decreases represent reductions in inflammation.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants in the 4 mg and 8 mg Dose Groups Who Achieved an American College of Rheumatology 20 (ACR20) Responder Index Response Baseline Through Week 12   [ Time Frame: Baseline through Week 12 ]

2.  Secondary:   Percentage of Participants Who Achieved an ACR20 Responder Index Response Baseline Through Week 12 - Model Based Dose Response   [ Time Frame: Baseline through Week 12 ]

3.  Secondary:   Percentage of Participants Who Achieved an ACR20 Responder Index Response Baseline Through Week 24   [ Time Frame: Baseline through Weeks 2, 4, 8, 12, 16, 20, 24 ]

4.  Secondary:   Percentage of Participants Who Achieved an ACR20 Response Baseline Through Weeks 76 and 128   [ Time Frame: Baseline through Weeks 76 and 128 ]

5.  Secondary:   Percentage of Participants Who Achieved an ACR 50 Responder Index Response Baseline Through Week 24   [ Time Frame: Baseline through Weeks 2, 4, 8, 12, 16, 20, 24 ]

6.  Secondary:   Percentage of Participants Who Achieved an ACR50 Response Baseline Through Weeks 76 and 128   [ Time Frame: Baseline through Weeks 76 and 128 ]

7.  Secondary:   Percentage of Participants Who Achieved an ACR70 Responder Index Response Baseline Through Week 24   [ Time Frame: Baseline through Weeks 2, 4, 8, 12, 16, 20, 24 ]

8.  Secondary:   Percentage of Participants Who Achieved an ACR70 Response Baseline Through Weeks 76 and 128   [ Time Frame: Baseline through Weeks 76 and 128 ]

9.  Secondary:   Percentage of Participants Who Achieved an ACR50 Response Baseline Through Week 12 - Model Based Dose Response   [ Time Frame: Baseline through Week 12 ]

10.  Secondary:   ACR Percent Improvement (ACR-N)   [ Time Frame: Baseline through Week 12 ]

11.  Secondary:   Mean Change From Baseline to Weeks 12 and 24 in Tender and Swollen Joint Counts (TJC and SJC)   [ Time Frame: Baseline, Weeks 12 and 24 ]

12.  Secondary:   Mean Change From Baseline to Weeks 76 and 128 in TJC and SJC   [ Time Frame: Baseline, Weeks 76 and 128 ]

13.  Secondary:   Mean Change From Baseline to Weeks 12 and 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score   [ Time Frame: Baseline, Weeks 12 and 24 ]

14.  Secondary:   Mean Change From Baseline to Weeks 76 and 128 in HAQ-DI Score   [ Time Frame: Baseline, Weeks 76 and 128 ]

15.  Secondary:   Mean Change From Baseline to Weeks 12 and 24 in High-Sensitivity C-Reactive Protein (hsCRP)   [ Time Frame: Baseline, Weeks 12 and 24 ]

16.  Secondary:   Mean Change From Baseline to Weeks 76 and 128 in hsCRP   [ Time Frame: Baseline, Weeks 76 and 128 ]

17.  Secondary:   Mean Change From Baseline to Weeks 12 and 24 in Erythrocyte Sedimentation Rate (ESR)   [ Time Frame: Baseline, Weeks 12 and 24 ]

18.  Secondary:   Mean Change From Baseline to Weeks 76 and 128 in ESR   [ Time Frame: Baseline, Weeks 76 and 128 ]

19.  Secondary:   Mean Change From Baseline to Weeks 12 and 24 in Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity and Patient's Assessment of Pain   [ Time Frame: Baseline, Weeks 12 and 24 ]

20.  Secondary:   Mean Change From Baseline to Weeks 76 and 128 in Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity and Patient's Assessment of Pain   [ Time Frame: Baseline, Weeks 76 and 128 ]

21.  Secondary:   Mean Change From Baseline to Weeks 12 and 24 in Disease Activity Score (DAS) Based on the 28 Diarthrodial Joint Count and CRP Level (DAS28-CRP)   [ Time Frame: Baseline, Weeks 12 and 24 ]

22.  Secondary:   Mean Change From Baseline to Weeks 76 and 128 in DAS28-CRP   [ Time Frame: Baseline, Weeks 76 and 128 ]

23.  Secondary:   Percentage of Responders According to European League Against Rheumatism Responder Index Based on 28-joint Count (EULAR28) Baseline Through Weeks 12 and 24   [ Time Frame: Baseline through Weeks 12 and 24 ]

24.  Secondary:   Percentage of Responders According to EULAR28 Baseline Through Weeks 76 and 128   [ Time Frame: Baseline, Weeks 76 and 128 ]

25.  Secondary:   Percentage of Participants Meeting Low Disease Activity and Remission Based on the 28 Diarthrodial Joint Count (DAS28) Baseline Through Weeks 12 and 24   [ Time Frame: Baseline through Weeks 12 and 24 ]

26.  Secondary:   Percentage of Participants Meeting Low Disease Activity and Remission Based on the 28 Diarthrodial Joint Count (DAS28) Baseline Through Weeks 76 and 128   [ Time Frame: Baseline through Weeks 76 and 128 ]

27.  Secondary:   Mean Change From Baseline Through Week 12 in Duration (Minutes) of Morning Stiffness   [ Time Frame: Baseline, Weeks 4, 8, 12 ]

28.  Secondary:   Mean Change From Baseline to Week 12 in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores   [ Time Frame: Baseline, Week 12 ]

29.  Secondary:   Mean Change From Baseline to Week 12 in Brief Pain Inventory Modified Short Form (BPI-sf Modified) Worst-Pain-in-the Past-24-hours Item Score   [ Time Frame: Baseline, Week 12 ]

30.  Secondary:   Mean Change From Baseline to Week 12 in Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) Score   [ Time Frame: Baseline, Week 12 ]

31.  Secondary:   Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104   [ Time Frame: Baseline through 24 weeks ]

32.  Secondary:   Population PK: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of LY3009104   [ Time Frame: Baseline through 24 weeks ]

33.  Secondary:   Mean Change From Baseline Through Week 12 in the ENSEMBLE Minimum Data Set 1.0   [ Time Frame: Baseline, 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked 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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01185353     History of Changes
Other Study ID Numbers: 13854
I4V-MC-JADA ( Other Identifier: Eli Lilly and Company )
CTRI/2011/06/001834 ( Registry Identifier: Clinical Trials Registry India )
First Submitted: August 18, 2010
First Posted: August 19, 2010
Results First Submitted: March 10, 2017
Results First Posted: April 21, 2017
Last Update Posted: June 16, 2017