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A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients (ARABESC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02260791
First Posted: October 9, 2014
Last Update Posted: October 20, 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.
Information provided by (Responsible Party):
Fujifilm Kyowa Kirin Biologics Co., Ltd.
Results First Submitted: July 5, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Arthritis, Rheumatoid
Interventions: Drug: FKB327
Drug: Humira®

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled in 109 sites in 12 countries in 3 geographical regions: North America, Europe and Rest of World. The first participant enrolled on 05 January 2015 and the last participant completed on 12 July 2016.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Screening details:

Patients were randomised in a 1:1 ratio to receive either FKB327 40 mg eow or Humira 40 mg eow using the following stratification factors: prior biological treatment for Rheumatoid Arthritis (RA) (yes/no) and Screening disease activity (DAS28-CRP ≤5.1/>5.1).


Reporting Groups
  Description
FKB327 Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
Humira® Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.

Participant Flow:   Overall Study
    FKB327   Humira®
STARTED   366   362 
COMPLETED   333   328 
NOT COMPLETED   33   34 
Lost to Follow-up                4                4 
Lack of Efficacy                2                1 
Adverse Event                13                9 
Death                1                0 
Withdrawal by Subject                11                16 
Screen failure                0                1 
Protocol deviation                2                3 



  Baseline Characteristics
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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.
The Safety Analysis Set was defined as the set of patients who received at least 1 dose of randomised treatment.

Reporting Groups
  Description
FKB327 Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
Humira® Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
Total Total of all reporting groups

Baseline Measures
   FKB327   Humira®   Total 
Overall Participants Analyzed 
[Units: Participants]
 366   362   728 
Age 
[Units: Years]
Mean (Full Range)
 53 
 (18 to 85) 
 53.6 
 (21 to 93) 
 53.3 
 (18 to 93) 
Age, Customized 
[Units: Participants]
Count of Participants
     
<18 years   0   0   0 
Between 18 and 65 years   302   299   601 
>65 years   64   63   127 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      281  76.8%      284  78.5%      565  77.6% 
Male      85  23.2%      78  21.5%      163  22.4% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   0.3%      1   0.3%      2   0.3% 
Asian      1   0.3%      1   0.3%      2   0.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2   0.5%      4   1.1%      6   0.8% 
White      311  85.0%      308  85.1%      619  85.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      51  13.9%      48  13.3%      99  13.6% 
Region of Enrollment 
[Units: Participants]
     
Canada   3   4   7 
Romania   15   13   28 
United States   39   39   78 
Czech Republic   33   34   67 
Ukraine   56   58   114 
Poland   67   67   134 
Bulgaria   7   7   14 
Chile   20   21   41 
Peru   51   49   100 
Germany   14   12   26 
Spain   4   6   10 
Russia   57   52   109 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   American College of Rheumatology (ACR) 20 Response Rate   [ Time Frame: Week 24 ]

2.  Secondary:   Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score   [ Time Frame: Week 24 ]

3.  Secondary:   ACR20 Response Rates Over Time   [ Time Frame: Week 24 ]

4.  Secondary:   ACR50 Response Rates Over Time   [ Time Frame: Week 24 ]

5.  Secondary:   ACR70 Response Rates Over Time   [ Time Frame: Week 24 ]

6.  Secondary:   Swollen Joint Count   [ Time Frame: Week 24 ]

7.  Secondary:   Tender Joint Count   [ Time Frame: Week 24 ]

8.  Secondary:   Analysis of Serum C-Reactive Protein (CRP) Concentration   [ Time Frame: Week 24 ]

9.  Secondary:   Patient Assessment of Disease Activity   [ Time Frame: Week 24 ]

10.  Secondary:   Physician Assessment of Disease Activity   [ Time Frame: Week 24 ]

11.  Secondary:   Patient's Assessment of Pain   [ Time Frame: Week 24 ]

12.  Secondary:   Health Assessment Questionnaire Disability Index (HAQ-DI)   [ Time Frame: Week 24 ]

13.  Secondary:   DAS28-CRP Score Over Time   [ Time Frame: Baseline and Week 24 ]

14.  Secondary:   DAS28 Score Based on Erythrocyte Sedimentation Rate (DAS28-ESR)   [ Time Frame: Baseline, Week 12 and Week 24 ]

15.  Other Pre-specified:   Percentage of Patients Developing Anti-drug Antibodies (ADAs)   [ Time Frame: Week 24 ]

16.  Other Pre-specified:   Trough Adalimumab Concentration   [ Time Frame: Week 24 ]


  Serious Adverse Events
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Time Frame Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Additional Description Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.

Reporting Groups
  Description
FKB327 Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
Humira® Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.

Serious Adverse Events
    FKB327   Humira®
Total, All-Cause Mortality     
# participants affected / at risk   1/366 (0.27%)   0/362 (0.00%) 
Total, Serious Adverse Events     
# participants affected / at risk   15/366 (4.10%)   19/362 (5.25%) 
Gastrointestinal disorders     
Anal fistula * 1     
# participants affected / at risk   1/366 (0.27%)   0/362 (0.00%) 
# events   1   0 
Hepatobiliary disorders     
Cholelithiasis * 1     
# participants affected / at risk   0/366 (0.00%)   1/362 (0.28%) 
# events   0   1 
Immune system disorders     
Amyloidosis * 1     
# participants affected / at risk   1/366 (0.27%)   0/362 (0.00%) 
# events   1   0 
Infections and infestations     
Pneumonia * 1     
# participants affected / at risk   3/366 (0.82%)   0/362 (0.00%) 
# events   3   0 
Disseminated tuberculosis * 1     
# participants affected / at risk   1/366 (0.27%)   1/362 (0.28%) 
# events   1   1 
Pulmonary tuberculosis * 1     
# participants affected / at risk   0/366 (0.00%)   2/362 (0.55%) 
# events   0   2 
Bronchopneumonia * 1     
# participants affected / at risk   1/366 (0.27%)   0/362 (0.00%) 
# events   1   0 
Cervicitis * 1     
# participants affected / at risk   1/366 (0.27%)   0/362 (0.00%) 
# events   1   0 
Erysipelas * 1     
# participants affected / at risk   1/366 (0.27%)   0/362 (0.00%) 
# events   1   0 
Gangrene * 1     
# participants affected / at risk   1/366 (0.27%)   0/362 (0.00%) 
# events   1   0 
Latent tuberculosis * 1     
# participants affected / at risk   1/366 (0.27%)   0/362 (0.00%) 
# events   1   0 
Osteomyelitis chronic * 1     
# participants affected / at risk   0/366 (0.00%)   1/362 (0.28%) 
# events   0   1 
Pyelonephritis acute * 1     
# participants affected / at risk   0/366 (0.00%)   1/362 (0.28%) 
# events   0   1 
Sepsis * 1     
# participants affected / at risk   1/366 (0.27%)   0/362 (0.00%) 
# events   1   0 
Urinary tract infection * 1     
# participants affected / at risk   1/366 (0.27%)   0/362 (0.00%) 
# events   1   0 
Injury, poisoning and procedural complications     
Hip fracture * 1     
# participants affected / at risk   0/366 (0.00%)   2/362 (0.55%) 
# events   0   2 
Femoral neck fracture * 1     
# participants affected / at risk   0/366 (0.00%)   1/362 (0.28%) 
# events   0   1 
Spinal compression fracture * 1     
# participants affected / at risk   0/366 (0.00%)   1/362 (0.28%) 
# events   0   1 
Traumatic fracture * 1     
# participants affected / at risk   0/366 (0.00%)   1/362 (0.28%) 
# events   0   1 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Squamous cell carcinoma * 1     
# participants affected / at risk   1/366 (0.27%)   1/362 (0.28%) 
# events   1   1 
Lymphoma * 1     
# participants affected / at risk   0/366 (0.00%)   1/362 (0.28%) 
# events   0   1 
Plasma cell myeloma * 1     
# participants affected / at risk   1/366 (0.27%)   0/362 (0.00%) 
# events   1   0 
Uterine leiomyoma * 1     
# participants affected / at risk   0/366 (0.00%)   1/362 (0.28%) 
# events   0   1 
Nervous system disorders     
Cerebrovascular accident * 1     
# participants affected / at risk   1/366 (0.27%)   1/362 (0.28%) 
# events   1   1 
Renal and urinary disorders     
Nephrotic syndrome * 1     
# participants affected / at risk   1/366 (0.27%)   0/362 (0.00%) 
# events   1   0 
Renal colic * 1     
# participants affected / at risk   0/366 (0.00%)   1/362 (0.28%) 
# events   0   1 
Respiratory, thoracic and mediastinal disorders     
Lung infiltration * 1     
# participants affected / at risk   0/366 (0.00%)   1/362 (0.28%) 
# events   0   1 
Skin and subcutaneous tissue disorders     
Lichen sclerosus * 1     
# participants affected / at risk   1/366 (0.27%)   0/362 (0.00%) 
# events   1   0 
Vascular disorders     
Aortic aneurysm * 1     
# participants affected / at risk   0/366 (0.00%)   1/362 (0.28%) 
# events   0   1 
Thrombophlebitis * 1     
# participants affected / at risk   1/366 (0.27%)   0/362 (0.00%) 
# events   1   0 
Thrombosis * 1     
# participants affected / at risk   0/366 (0.00%)   1/362 (0.28%) 
# events   0   1 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (17.1)




  Other Adverse Events


  Limitations and Caveats
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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 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: Clinical Trial Information
Organization: Fujifilm Kyowa Kirin Biologics Co., Ltd., EU Branch
phone: +44 1896 668 173
e-mail: Clinical-Trials@fk-b.com



Responsible Party: Fujifilm Kyowa Kirin Biologics Co., Ltd.
ClinicalTrials.gov Identifier: NCT02260791     History of Changes
Other Study ID Numbers: FKB327-002
First Submitted: July 29, 2014
First Posted: October 9, 2014
Results First Submitted: July 5, 2017
Results First Posted: September 20, 2017
Last Update Posted: October 20, 2017