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

October 23, 2017 updated by: Fujifilm Kyowa Kirin Biologics Co., Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

728

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
  • Canada
    • Ontario
      • Mississauga, Ontario, Canada
        • Research Site
      • St. Catherines, Ontario, Canada
        • Research Site
    • Quebec
      • Trois-Rivieres, Quebec, Canada
        • Research Site
  • Chile
      • Osorno, Chile
        • Research Site
      • Puerto Varas, Chile
        • Research Site
      • Santiago, Chile
        • Research Site G
      • Santiago, Chile
        • Research Site M
      • Temuco, Chile
        • Research Site
  • Czechia
      • Brno, Czechia
        • Research Site
      • Hlucin, Czechia
        • Research Site
      • Prague, Czechia
        • Research Site
      • Prague, Czechia
        • Research Site U
      • Uherske Hradiste, Czechia
        • Research Site
      • Zlin, Czechia
        • Research Site
  • Germany
      • Aachen, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Hildesheim, Germany
        • Research Site
      • Munich, Germany
        • Research Site
      • Ratingen, Germany
        • Research Site
  • Peru
      • Arequipa, Peru
        • Research Site B
      • Arequipa, Peru
        • Research Site M
      • Lima, Peru
        • Research Site CA
      • Lima, Peru
        • Research Site CH
      • Lima, Peru
        • Research Site PA
      • Lima, Peru
        • Research Site PE
      • Lima, Peru
        • Research Site S
  • Poland
      • Bialystok, Poland
        • Research Site D
      • Bialystok, Poland
        • Research Site R
      • Gdynia, Poland
        • Research Site
      • Katowice, Poland
        • Research Site
      • Krakow, Poland
        • Research Site KL
      • Krakow, Poland
        • Research Site KR
      • Lublin, Poland
        • Research Site
      • Poznan, Poland
        • Research Site P
      • Poznan, Poland
        • Research Site RH
      • Torun, Poland
        • Research Site
  • Romania
      • Braila, Romania
        • Research Site
      • Brasov, Romania
        • Research Site
      • Bucharest, Romania
        • Research Site C
      • Bucharest, Romania
        • Research Site R
      • Bucharest, Romania
        • Research Site T
      • Constanta, Romania
        • Research Site
      • Galati, Romania
        • Research Site
      • Sfântu Gheorghe, Romania
        • Research Site
    • Bihor
      • Oradea, Bihor, Romania
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation
        • Research Site D
      • Moscow, Russian Federation
        • Research Site SM
      • Moscow, Russian Federation
        • Research Site St
      • Nizhny Novgorod, Russian Federation
        • Research Site
      • Penza, Russian Federation
        • Research Site
      • Perm, Russian Federation
        • Research Site
      • Ryazan, Russian Federation
        • Research Site
      • Saint-Petersburg, Russian Federation
        • Research Site B
      • Saint-Petersburg, Russian Federation
        • Research Site Z
      • Saratov, Russian Federation
        • Research Site
      • Smolensk, Russian Federation
        • Research Site
      • Vladimir, Russian Federation
        • Research Site
      • Yaroslavl, Russian Federation
        • Research Site E
      • Yaroslavl, Russian Federation
        • Research Site S
    • Bashkortostan Republic
      • Ufa, Bashkortostan Republic, Russian Federation
        • Research Site
    • Karelia Republic
      • Petrozavodsk, Karelia Republic, Russian Federation
        • Research Site
    • Tatarstan Republic
      • Kazan, Tatarstan Republic, Russian Federation
        • Research Site
  • Spain
      • Barcelona, Spain
        • Research Site A
      • Barcelona, Spain
        • Research Site G
      • Malaga, Spain
        • Research Site
    • La Coruna
      • Santiago de Compostela, La Coruna, Spain
        • Research Site
    • Vizcaya
      • Bilbao, Vizcaya, Spain
        • Research Site
  • Ukraine
      • Chernivtsi, Ukraine
        • Research Site
      • Ivano-Frankivsk, Ukraine
        • Research Site
      • Kyiv, Ukraine
        • Research Site A
      • Kyiv, Ukraine
        • Research Site B
      • Kyiv, Ukraine
        • Research Site P
      • Lutsk, Ukraine
        • Research Site
      • Lviv, Ukraine
        • Research Site C
      • Lviv, Ukraine
        • Research Site N
      • Poltava, Ukraine
        • Research Site
      • Ternopil, Ukraine
        • Research Site
      • Uzhgorod, Ukraine
        • Research Site
      • Vinnytsia, Ukraine
        • Research Site G
      • Vinnytsia, Ukraine
        • Research Site Sh
      • Vinnytsia, Ukraine
        • Research Site St
  • United States
    • Arizona
      • Peoria, Arizona, United States
        • Research Site
    • California
      • Palm Desert, California, United States
        • Research Site
    • Florida
      • Boca Raton, Florida, United States
        • Research Site
      • Brandon, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Miami Lakes, Florida, United States
        • Research Site
      • Sarasota, Florida, United States
        • Research Site
    • Louisiana
      • Shreveport, Louisiana, United States
        • Research Site
    • Michigan
      • Lansing, Michigan, United States
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States
        • Research Site
    • Ohio
      • Middleburg Heights, Ohio, United States
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
        • Research Site
    • Texas
      • Amarillo, Texas, United States
        • Research Site
      • Austin, Texas, United States
        • Research Site
      • Mesquite, Texas, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FKB327
Patients will receive FKB327 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks.
Drug: FKB327
Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.
Active Comparator: Humira®
Patients will receive Humira® 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks.
Drug: Humira®
Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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])
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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])
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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])
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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])
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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.
Baseline and Week 24
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.
Baseline and Week 24
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.
Baseline and Week 24
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.
Baseline and Week 24
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.
Baseline and Week 24
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.
Baseline and Week 24
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.
Baseline and Week 24
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.
Baseline and Week 24
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.
Baseline, Week 12 and Week 24

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and last sampling day
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).
Week 2, Week 4, Week 12, Week 20, and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujifilm Kyowa Kirin Biologics Co., Ltd.

Investigators

  • Principal Investigator: Josephine Glover, MD, Coephycient Pharmaceutical Consultancy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

July 29, 2014

First Submitted That Met QC Criteria

October 6, 2014

First Posted (Estimate)

October 9, 2014

Study Record Updates

Last Update Posted (Actual)

November 28, 2017

Last Update Submitted That Met QC Criteria

October 23, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FKB327-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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