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A Rheumatoid Arthritis Study in Participants (FLEX O)

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ClinicalTrials.gov Identifier: NCT01202760
Recruitment Status : Completed
First Posted : September 16, 2010
Results First Posted : April 25, 2018
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: LY2127399
Drug: Placebo

  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
No text entered.

Reporting Groups
  Description
120 mg LY2127399

LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240-mg (2 SC injections of 120 mg each) loading dose of LY2127399 when initiating treatment.

During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of Placebo every 2 weeks.

After 16 weeks, non-responders received 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.

90 mg LY2127399

LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180-mg (2 SC injections of 90 mg each) loading dose of LY2127399 when initiating treatment.

After 16 weeks, non-responders continued to receive 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.

Placebo

Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections of Placebo when initiating treatment.

After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.


Participant Flow:   Overall Study
    120 mg LY2127399   90 mg LY2127399   Placebo
STARTED   379   374   251 
Received at Least One Dose of Study Drug   379   371   250 
COMPLETED   332   322   216 
NOT COMPLETED   47   52   35 
Entry Criteria Not Met                0                3                1 
Adverse Event                11                9                10 
Death                2                1                0 
Lack of Efficacy                6                8                7 
Lost to Follow-up                0                2                1 
Parent / Caregiver Decision                0                1                0 
Withdrawal by Subject                17                18                14 
Physician Decision                0                1                0 
Protocol Violation                7                5                2 
Sponsor Decision                4                4                0 



  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, including participants who did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.

Reporting Groups
  Description
120 mg LY2127399

LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240-mg (2 SC injections of 120 mg each) loading dose of LY2127399 when initiating treatment.

During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of Placebo every 2 weeks.

After 16 weeks, non-responders received 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.

90 mg LY2127399

LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180-mg (2 SC injections of 90 mg each) loading dose of LY2127399 when initiating treatment.

After 16 weeks, non-responders continued to receive 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.

Placebo

Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections of Placebo when initiating treatment.

After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.

Total Total of all reporting groups

Baseline Measures
   120 mg LY2127399   90 mg LY2127399   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 379   374   251   1004 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.4  (11.2)   50.6  (12.2)   51.0  (12.0)   51.4  (11.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      293  77.3%      295  78.9%      209  83.3%      797  79.4% 
Male      86  22.7%      79  21.1%      42  16.7%      207  20.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      38  10.0%      47  12.6%      24   9.6%      109  10.9% 
Not Hispanic or Latino      193  50.9%      185  49.5%      133  53.0%      511  50.9% 
Unknown or Not Reported      148  39.1%      142  38.0%      94  37.5%      384  38.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      13   3.4%      21   5.6%      9   3.6%      43   4.3% 
Asian      96  25.3%      93  24.9%      59  23.5%      248  24.7% 
Native Hawaiian or Other Pacific Islander      1   0.3%      1   0.3%      0   0.0%      2   0.2% 
Black or African American      12   3.2%      13   3.5%      14   5.6%      39   3.9% 
White      254  67.0%      235  62.8%      162  64.5%      651  64.8% 
More than one race      2   0.5%      9   2.4%      6   2.4%      17   1.7% 
Unknown or Not Reported      1   0.3%      2   0.5%      1   0.4%      4   0.4% 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
United States   126   125   83   334 
Argentina   7   6   5   18 
Colombia   9   9   5   23 
Mexico   20   25   15   60 
Bulgaria   13   13   12   38 
Croatia   2   1   3   6 
Hungary   3   12   6   21 
Lithuania   14   10   11   35 
Poland   27   22   12   61 
Romania   0   1   3   4 
Russia   14   13   8   35 
Slovakia   8   3   2   13 
Ukraine   16   15   6   37 
Australia   2   3   2   7 
India   14   9   9   32 
Japan   44   42   28   114 
South Korea   7   6   5   18 
Malaysia   2   4   1   7 
New Zealand   6   2   6   14 
Sri Lanka   4   4   2   10 
South Africa   32   38   24   94 
Taiwan   9   11   3   23 
Tender Joint Count (68 Count) [1] 
[Units: Joint count]
Mean (Standard Deviation)
 22.8  (15.5)   23.7  (17.1)   22.8  (15.2)   23.2  (16.0) 
[1] Tender joint count 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 is translated into a single tender-versus-nontender dichotomy.
Swollen Joint Count (66 Count) [1] 
[Units: Joint count]
Mean (Standard Deviation)
 14.8  (11.6)   15.3  (11.6)   14.3  (10.6)   14.8  (11.4) 
[1] Swollen joint count 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.


  Outcome Measures

1.  Primary:   Percentage of Participants With American College of Rheumatology 20% (ACR20) Response   [ Time Frame: Up to 24 weeks ]

2.  Secondary:   Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Responses   [ Time Frame: Up to 24 weeks ]

3.  Secondary:   Mean Percent Improvement in American College of Rheumatology Percent Improvement (ACR-N)   [ Time Frame: Up to 24 weeks ]

4.  Secondary:   Change From Baseline to 24 Weeks in Tender Joint Count (68 Joint Count)   [ Time Frame: Baseline, up to 24 weeks ]

5.  Secondary:   Change From Baseline to 24 Weeks in Swollen Joint Count (66 Joint Count)   [ Time Frame: Baseline, up to 24 weeks ]

6.  Secondary:   Change From Baseline to 24 Weeks in Participant's Assessment of Pain (Visual Analog Scale)   [ Time Frame: Baseline, up to 24 weeks ]

7.  Secondary:   Change From Baseline to 24 Weeks in Participant's Global Assessment of Disease Activity (Visual Analog Scale)   [ Time Frame: Baseline, up to 24 weeks ]

8.  Secondary:   Change From Baseline to 24 Weeks in Physician’s Global Assessment of Disease Activity (Visual Analog Scale)   [ Time Frame: Baseline, up to 24 weeks ]

9.  Secondary:   Change From Baseline to 24 Weeks in Disease Activity Score (Based on 28 Joint Count)-C-Reactive Protein (DAS28-CRP)   [ Time Frame: Baseline, up to 24 weeks ]

10.  Secondary:   Change From Baseline to 24 Weeks in Health Assessment Questionnaire-Disability Index (HAQ-DI)   [ Time Frame: Baseline, up to 24 weeks ]

11.  Secondary:   Time to American College of Rheumatology 20% (ACR20) Response   [ Time Frame: Baseline through 24 weeks ]

12.  Secondary:   Probability of an ACR20 Response by 24 Weeks   [ Time Frame: Baseline through 24 weeks ]

13.  Secondary:   Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR) Response   [ Time Frame: Up to 24 weeks ]

14.  Secondary:   Change From Baseline to 24 Weeks in Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Survey Domain and Summary Scores   [ Time Frame: Baseline, up to 24 weeks ]

15.  Secondary:   Change From Baseline in C-reactive Protein (CRP) up to Week 24 Endpoint   [ Time Frame: Baseline, up to 24 weeks ]

16.  Secondary:   Change From Baseline to 24 Weeks in Absolute CD3-CD20+ B-cell Counts   [ Time Frame: Baseline, up to 24 weeks ]

17.  Secondary:   Change From Baseline to 24 Weeks in Serum Immunoglobulin (Ig) Levels   [ Time Frame: Baseline, up to 24 weeks ]

18.  Secondary:   Population Pharmacokinetics (PK)   [ Time Frame: Baseline through 24 weeks ]

19.  Secondary:   Percentage of Participants Developing Anti-LY2127399 Antibodies   [ Time Frame: Baseline through 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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



Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01202760     History of Changes
Other Study ID Numbers: 12978
H9B-MC-BCDO ( Other Identifier: Eli Lilly and Company )
CTRI/2011/07/001867 ( Registry Identifier: Clinical Trials Registry India )
First Submitted: September 14, 2010
First Posted: September 16, 2010
Results First Submitted: March 24, 2018
Results First Posted: April 25, 2018
Last Update Posted: April 25, 2018