ClinicalTrials.gov
ClinicalTrials.gov Menu

A Moderate to Severe Rheumatoid Arthritis Study (RA-BEACON)

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: NCT01721044
Recruitment Status : Completed
First Posted : November 2, 2012
Results First Posted : January 18, 2018
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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

  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
Participants who did not adequately respond (nonresponders) to study drug were eligible for rescue treatment with baricitinib 4 mg beginning at Week 16. Nonresponders were defined as lack of improvement of at least 20% in both tender joint count and swollen joint count at both Weeks 14 and 16 compared to baseline.

Reporting Groups
  Description
Placebo Placebo administered orally (PO) once daily (QD) through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
Baricitinib 2 mg Baricitinib 2 milligram (mg) administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Baricitinib 4 mg Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.

Participant Flow for 2 periods

Period 1:   Treatment Period
    Placebo   Baricitinib 2 mg   Baricitinib 4 mg
STARTED   176   174 [1]   177 
Rescue Week 16-24   56   38   33 
COMPLETED   144   157   158 
NOT COMPLETED   32   17   19 
Adverse Event                7                7                10 
Death                0                0                1 
Lack of Efficacy                16                4                4 
Lost to Follow-up                0                0                1 
Physician Decision                1                0                2 
Protocol Violation                1                0                0 
Withdrawal by Subject                7                6                1 
[1] Randomized to 4mg (N=11) but received 2mg due to moderate renal impairment were included in 4mg arm

Period 2:   Follow Up
    Placebo   Baricitinib 2 mg   Baricitinib 4 mg
STARTED   19 [1]   9 [1]   20 [2] 
COMPLETED   19   9   20 
NOT COMPLETED   0   0   0 
[1] Participants from treatment who entered the post-treatment follow-up period.
[2] Participants from treatment and rescue who entered the post-treatment follow-up period.



  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.
Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug.

Reporting Groups
  Description
Placebo Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Baricitinib 2 mg Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Baricitinib 4 mg Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Total Total of all reporting groups

Baseline Measures
   Placebo   Baricitinib 2 mg   Baricitinib 4 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 176   174   177   527 
Age 
[Units: Years]
Mean (Standard Deviation)
       
Participants Analyzed   176   174   177   527 
   56.0  (10.7)   55.1  (11.1)   55.9  (11.3)   55.7  (11.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Participants Analyzed   176   174   177   527 
Female   145   137   149   431 
Male   31   37   28   96 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Participants Analyzed   176   174   177   527 
American Indian or Alaska Native   9   12   11   32 
Asian   11   9   12   32 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   8   9   7   24 
White   147   144   144   435 
More than one race   1   0   0   1 
Unknown or Not Reported   0   0   3   3 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
Argentina         
Participants Analyzed   176   174   177   527 
Argentina   9   5   7   21 
Australia         
Participants Analyzed   176   174   177   527 
Australia   8   9   4   21 
Austria         
Participants Analyzed   176   174   177   527 
Austria   5   3   8   16 
Belgium         
Participants Analyzed   176   174   177   527 
Belgium   1   1   1   3 
Canada         
Participants Analyzed   176   174   177   527 
Canada   1   4   3   8 
Denmark         
Participants Analyzed   176   174   177   527 
Denmark   2   3   1   6 
France         
Participants Analyzed   176   174   177   527 
France   7   10   7   24 
Germany         
Participants Analyzed   176   174   177   527 
Germany   8   5   6   19 
Greece         
Participants Analyzed   176   174   177   527 
Greece   4   3   2   9 
Israel         
Participants Analyzed   176   174   177   527 
Israel   9   8   13   30 
Italy         
Participants Analyzed   176   174   177   527 
Italy   2   3   3   8 
Japan         
Participants Analyzed   176   174   177   527 
Japan   6   6   8   20 
Mexico         
Participants Analyzed   176   174   177   527 
Mexico   9   12   10   31 
Netherlands         
Participants Analyzed   176   174   177   527 
Netherlands   0   1   1   2 
Poland         
Participants Analyzed   176   174   177   527 
Poland   10   13   9   32 
South Korea         
Participants Analyzed   176   174   177   527 
South Korea   4   3   3   10 
Spain         
Participants Analyzed   176   174   177   527 
Spain   10   7   10   27 
Switzerland         
Participants Analyzed   176   174   177   527 
Switzerland   1   2   4   7 
Turkey         
Participants Analyzed   176   174   177   527 
Turkey   1   1   1   3 
United Kingdom         
Participants Analyzed   176   174   177   527 
United Kingdom   2   1   1   4 
United States         
Participants Analyzed   176   174   177   527 
United States   77   74   75   226 
Duration of Rheumatoid Arthritis [1] 
[Units: Years]
Mean (Standard Deviation)
       
Participants Analyzed   176   174   177   527 
   14.0  (9.6)   13.7  (8.0)   14.3  (9.4)   14.0  (9.0) 
[1] Time from Symptom Onset of Rheumatoid Arthritis
Tender Joint Count of 68 Evaluable Joints [1] 
[Units: Number of Joints]
Mean (Standard Deviation)
       
Participants Analyzed   174   174   177   525 
   28.3  (16.4)   31.0  (16.3)   28.1  (15.6)   29.1  (16.1) 
[1] Tender joint count based on 68 joints.
Swollen Joint Count of 66 Evaluable Joints [1] 
[Units: Number of Joints]
Mean (Standard Deviation)
       
Participants Analyzed   174   174   177   525 
   17.2  (10.8)   18.6  (12.3)   16.3  (8.9)   17.4  (10.8) 
[1] Swollen joint count based on 66 joints.
High Sensitivity C-Reactive Protein (hsCRP) 
[Units: Milligrams/liter (mg/L)]
Mean (Standard Deviation)
       
Participants Analyzed   176   174   177   527 
   20.64  (25.26)   19.87  (22.48)   19.76  (24.84)   20.09  (24.19) 


  Outcome Measures

1.  Primary:   Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response - Placebo Versus Baricitinib 4 mg   [ Time Frame: Week 12 ]

2.  Secondary:   Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 4 mg   [ Time Frame: Baseline, Week 12 ]

3.  Secondary:   Change From Baseline in the Disease Activity Score Based on a 28-Joint Count (DAS-28) High Sensitivity C-Reactive Protein (hsCRP) - Placebo Versus Baricitinib 4 mg   [ Time Frame: Baseline, Week 12 ]

4.  Secondary:   Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission - Simplified Disease Activity Index (SDAI) ≤3.3 - Placebo Versus Baricitinib 4 mg   [ Time Frame: Week 12 ]

5.  Secondary:   Percentage of Participants Achieving ACR20 Response - Placebo Versus Baricitinib 2 mg   [ Time Frame: Week 12 ]

6.  Secondary:   Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 2 mg   [ Time Frame: Baseline, Week 12 ]

7.  Secondary:   Change From Baseline in the DAS28 - hsCRP - Placebo Versus Baricitinib 2 mg   [ Time Frame: Baseline, Week 12 ]

8.  Secondary:   Percentage of Participants Achieving ACR/EULAR Remission - SDAI ≤3.3 - Placebo Versus Baricitinib 2 mg   [ Time Frame: Week 12 ]

9.  Secondary:   Percentage of Participants Achieving ACR20 Response   [ Time Frame: Week 24 ]

10.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response   [ Time Frame: Week 12 and Week 24 ]

11.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response   [ Time Frame: Week 12 and Week 24 ]

12.  Secondary:   Change From Baseline in DAS28 - Erythrocyte Sedimentation Rate (ESR)   [ Time Frame: Baseline, Week 12 ]

13.  Secondary:   Change From Baseline in Clinical Disease Activity Index Score   [ Time Frame: Baseline, Week 24 ]

14.  Secondary:   Change From Baseline in Measures of SDAI Score   [ Time Frame: Baseline, Week 24 ]

15.  Secondary:   Percentage of Participants Achieving ACR/EULAR Remission – Boolean Remission   [ Time Frame: Week 24 ]

16.  Secondary:   Change From Baseline in Duration of Participant Reported Outcome - Morning Joint Stiffness   [ Time Frame: Baseline, Week 24 ]

17.  Secondary:   Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)   [ Time Frame: Baseline, Week 24 ]

18.  Secondary:   Change From Baseline in Worst Joint Pain NRS   [ Time Frame: Baseline, Week 24 ]

19.  Secondary:   Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Scale Scores   [ Time Frame: Baseline, Week 12, Week 24 ]

20.  Secondary:   Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)   [ Time Frame: Baseline, Week 12, Week 24 ]

21.  Secondary:   Change From Baseline in European Quality of Life-5 Dimensions-5 Level Scores   [ Time Frame: Baseline, Week 12, Week 24 ]

22.  Secondary:   Percentage Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores   [ Time Frame: Baseline, Week 12, Week 24 ]

23.  Secondary:   Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib   [ Time Frame: Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose. ]

24.  Secondary:   Population PK: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib   [ Time Frame: Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose. ]


  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


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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01721044     History of Changes
Other Study ID Numbers: 14058
I4V-MC-JADW ( Other Identifier: Eli Lilly and Company )
First Submitted: November 1, 2012
First Posted: November 2, 2012
Results First Submitted: March 10, 2017
Results First Posted: January 18, 2018
Last Update Posted: January 18, 2018