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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: November 28, 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.
July 29, 2014
October 9, 2014
July 5, 2017
September 20, 2017
November 28, 2017
December 2014
July 2016   (Final data collection date for primary outcome measure)
American College of Rheumatology (ACR) 20 Response Rate [ Time Frame: Week 24 ]

The primary efficacy endpoint was the ACR20 response rate at Week 24.

An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.

  • Acute phase reactant (CRP)
  • Patient global assessment of disease activity
  • Physician global assessment of disease activity
  • Patient pain scale
  • Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index [HAQ-DI])
American College of Rheumatology (ACR) 20 Response Rate [ Time Frame: Week 24 ]
Complete list of historical versions of study NCT02260791 on ClinicalTrials.gov Archive Site
  • Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 ]
    The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The DAS28-CRP is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.
  • ACR20 Response Rates Over Time [ Time Frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 ]

    An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.

    • Acute phase reactant (CRP)
    • Patient global assessment of disease activity
    • Physician global assessment of disease activity
    • Patient pain scale
    • Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index [HAQ-DI])
  • ACR50 Response Rates Over Time [ Time Frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 ]

    An ACR50 response meant that the patient achieved a 50% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.

    • Acute phase reactant (CRP)
    • Patient global assessment of disease activity
    • Physician global assessment of disease activity
    • Patient pain scale
    • Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index [HAQ-DI])
  • ACR70 Response Rates Over Time [ Time Frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 ]

    An ACR70 response meant that the patient achieved a 70% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.

    • Acute phase reactant (CRP)
    • Patient global assessment of disease activity
    • Physician global assessment of disease activity
    • Patient pain scale
    • Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index [HAQ-DI])
  • Swollen Joint Count [ Time Frame: Baseline and Week 24 ]
    Counts of swollen joints from amongst 66 selected joints performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66 with higher scores indicating severe disease. Swollen joint count is a value of the individual ACR core set variables.
  • Tender Joint Count [ Time Frame: Baseline and Week 24 ]
    Counts of tender joints from amongst 68 selected joints were performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68 with higher scores indicating severe disease.Tender joint count is a value of the individual ACR core set variables.
  • Analysis of Serum C-Reactive Protein (CRP) Concentration [ Time Frame: Baseline and Week 24 ]
    Analysis of serum C-Reactive Protein (CRP) concentrations for inclusion in the ACR20/50/70 and DAS28-CRP scores was performed by a central laboratory. Elevation of CRP is a nonspecific marker of inflammation. Values above 10 mg/L were considered to be abnormally high. Decrease in level of CRP indicates reduction in inflammation.
  • Patient Assessment of Disease Activity [ Time Frame: Baseline and Week 24 ]
    Patient assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scales (ranging from very well (0) to extremely bad (100)).The patient assessment of disease activity VAS will contribute to the calculation of the DAS28 score. The patient assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response.
  • Physician Assessment of Disease Activity [ Time Frame: Baseline and Week 24 ]
    Physician assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scale (ranging from very low (0) to very high (100)). The physician assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response.
  • Patient's Assessment of Pain [ Time Frame: Baseline and Week 24 ]
    An injection site pain visual analogue score (VAS) will be administered to the patient. To determine the extent of the pain, patients will be asked to place a small vertical mark on a horizontal scale from 0 to 100, the ends of which are labelled with the extreme responses to be measured ("No pain" at 0 and "Intolerable pain" at 100). Patient's assessment of pain is a value of the individual ACR core set variables.
  • Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: Baseline and Week 24 ]
    The HAQ-DI is a 20-question, self-administered instrument that measures the patient's functional ability on a 4-level difficulty scale (0 to 3, with 0 representing normal or no difficulty and 3 representing inability to perform). Eight categories of functioning are included: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. This scale is sensitive to change and is a good predictor of future disability. HAQ-DI is a value of the individual ACR core set variables.
  • DAS28-CRP Score Over Time [ Time Frame: Baseline and Week 24 ]
    The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.
  • DAS28 Score Based on Erythrocyte Sedimentation Rate (DAS28-ESR) [ Time Frame: Baseline, Week 12 and Week 24 ]
    The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-ESR assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum ESR, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.
  • Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score [ Time Frame: Week 24 ]
  • ACR20 Response Rates Over Time [ Time Frame: Week 24 ]
  • ACR50 Response Rates Over Time [ Time Frame: Week 24 ]
  • ACR70 Response Rates Over Time [ Time Frame: Week 24 ]
  • Values of the individual ACR core set variables (swollen joint count, tender joint count, CRP, patient's assessment of disease activity, physician's assessment of disease activity, patient's assessment of pain, HAQ-DI) [ Time Frame: Week 24 ]
  • DAS28-CRP score and change in DAS28-CRP score over time [ Time Frame: Week 24 ]
  • DAS28 score based on erythrocyte sedimentation rate (DAS28-ESR) [ Time Frame: Weeks 12 and 24 ]
  • Percentage of Patients Developing Anti-drug Antibodies (ADAs) [ Time Frame: Baseline and last sampling day ]
    Blood samples for the assessment of ADA activity were collected at Baseline (Week 0), prior to dosing at Weeks 2, 4, 12, and 24.
  • Trough Adalimumab Concentration [ Time Frame: Week 2, Week 4, Week 12, Week 20, and Week 24 ]
    Blood samples for the quantification of adalimumab concentration in serum were collected at Baseline (Week 0), prior to dosing at Weeks 2, 4, 12 and 20, and Week 24. Samples were taken prior to dosing (trough samples).
  • Proportion of patients developing Anti-drug antibodies (ADAs) [ Time Frame: Week 24 ]
  • Trough Adalimumab Concentration [ Time Frame: Week 24 ]
  • Safety as assessed by adverse events, serious adverse events, serious infections, malignancies, vital signs, and laboratory abnormalities [ Time Frame: Week 26 ]
 
A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients
A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety With the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate
The purpose of the study is to compare the effectiveness and safety of FKB327 in comparison to Humira® in rheumatoid arthritis patients who have inadequate disease control on methotrexate.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • Drug: FKB327
    Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.
  • Drug: Humira®
    Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.
  • Experimental: FKB327
    Patients will receive FKB327 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks.
    Intervention: Drug: FKB327
  • Active Comparator: Humira®
    Patients will receive Humira® 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks.
    Intervention: Drug: Humira®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
728
July 2016
July 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female aged 18 years or over
  2. Patients have been diagnosed with Rheumatoid Arthritis (RA) for at least 3 months
  3. Patient has active RA
  4. Patient has taken a stable dose of methotrexate for at least 3 months

Exclusion Criteria:

  1. Patient has been previously treated with adalimumab
  2. Patient has been previously treated or has ongoing treatment with prohibited medications
  3. Patient has been immunised with a live or attenuated vaccine in past 4 weeks
  4. Patient has positive result for HIV, HBV, HCV or TB infection

Other Inclusion/Exclusion criteria may apply.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Canada,   Chile,   Czechia,   Germany,   Peru,   Poland,   Romania,   Russian Federation,   Spain,   Ukraine,   United States
Czech Republic,   Serbia
 
NCT02260791
FKB327-002
No
Not Provided
Not Provided
Fujifilm Kyowa Kirin Biologics Co., Ltd.
Fujifilm Kyowa Kirin Biologics Co., Ltd.
Not Provided
Principal Investigator: Josephine Glover, MD Coephycient Pharmaceutical Consultancy
Fujifilm Kyowa Kirin Biologics Co., Ltd.
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP