Arthritis, RheumatoidPhase 3ARABESCNCT02260791
A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients
A Phase 3 study testing FKB327 and Humira® in people with Arthritis, Rheumatoid, run by Fujifilm Kyowa Kirin Biologics Co., Ltd. at 100 sites in 12 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- FKB327 and Humira®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 728 participants
- Where
- 100 sitesin 12 countries
- Study dates
- Dec 2014to Jul 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 years or over
- Patients have been diagnosed with Rheumatoid Arthritis (RA) for at least 3 months
- Patient has active RA
- Patient has taken a stable dose of methotrexate for at least 3 months
Who cannot join
- Patient has been previously treated with adalimumab
- Patient has been previously treated or has ongoing treatment with prohibited medications
- Patient has been immunised with a live or attenuated vaccine in past 4 weeks
- Patient has positive result for HIV, HBV, HCV or TB infection
- Other Inclusion/Exclusion criteria may apply.
Trial locations and contacts
100 sites in 12 countries.
100 sites in 12 countries
Russia17 sites
Research Site
Kazan', Tatarstan Republic
Research Site D
Moscow
Research Site SM
Moscow
Research Site ST
Moscow
Research Site
Nizhny Novgorod
Research Site
Penza
Research Site
Perm
Research Site
Petrozavodsk, Karelia Republic
Research Site
Ryazan
Research Site B
Saint Petersburg
Research Site Z
Saint Petersburg
Research Site
Saratov
Research Site
Smolensk
Research Site
Ufa, Bashkortostan Republic
Research Site
Vladimir
Research Site E
Yaroslavl
Research Site S
Yaroslavl
United States16 sites
Research Site
Amarillo, Texas
Research Site
Austin, Texas
Research Site
Boca Raton, Florida
Research Site
Brandon, Florida
Research Site
Duncansville, Pennsylvania
Research Site
Durham, North Carolina
Research Site
Jacksonville, Florida
Research Site
Lansing, Michigan
Research Site
Mesquite, Texas
Research Site
Miami, Florida
Research Site
Miami Lakes, Florida
Research Site
Middleburg Heights, Ohio
Research Site
Palm Desert, California
Research Site
Peoria, Arizona
Research Site
Sarasota, Florida
Research Site
Shreveport, Louisiana
Ukraine14 sites
Research Site
Chernivtsi
Research Site
Ivano-Frankivsk
Research Site A
Kyiv
Research Site B
Kyiv
Research Site P
Kyiv
Research Site
Lutsk
Research Site C
Lviv
Research Site N
Lviv
Research Site
Poltava
Research Site
Ternopil
Research Site
Uzhhorod
Research Site G
Vinnytsia
Research Site Sh
Vinnytsia
Research Site St
Vinnytsia
Poland10 sites
Research Site D
Bialystok
Research Site R
Bialystok
Research Site
Gdynia
Research Site
Katowice
Research Site KL
Krakow
Research Site KR
Krakow
Research Site
Lublin
Research Site P
Poznan
Research Site RH
Poznan
Research Site
Torun
Romania9 sites
Research Site
Brăila
Research Site
Brasov
Research Site C
Bucharest
Research Site R
Bucharest
Research Site T
Bucharest
Research Site
Constanța
Research Site
Galati
Research Site
Oradea, Bihor County
Research Site
Sfantu Gheorghe
Peru7 sites
Research Site B
Arequipa
Research Site M
Arequipa
Research Site CA
Lima
Research Site CH
Lima
Research Site PA
Lima
Research Site PE
Lima
Research Site S
Lima
Czechia6 sites
Research Site
Brno
Research Site
Hlučín
Research Site U
Prague
Research Site
Prague
Research Site
Uherské Hradiště
Research Site
Zlín
Germany6 sites
Research Site
Aachen
Research Site
Berlin
Research Site
Hamburg
Research Site
Hildesheim
Research Site
Munich
Research Site
Ratingen
Chile5 sites
Research Site
Osorno
Research Site
Puerto Varas
Research Site G
Santiago
Research Site M
Santiago
Research Site
Temuco
Spain5 sites
Research Site A
Barcelona
Research Site G
Barcelona
Research Site
Bilbao, Vizcaya
Research Site
Málaga
Research Site
Santiago de Compostela, La Coruna
Canada3 sites
Research Site
Mississauga, Ontario
Research Site
Saint Catherines, Ontario
Research Site
Trois-Rivières, Quebec
About this study
Official title: 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.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- FKB327, Humira®
- Keywords
- Rheumatoid, Arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FKB327Drug
Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.
Humira®Drug
Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.
| Study group | Role | What they receive |
|---|---|---|
| FKB327 | Experimental | Patients will receive FKB327 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks. Receives: Drug: FKB327 |
| Humira® | Active comparator | Patients will receive Humira® 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks. Receives: Drug: Humira® |
What is being measured
The primary outcome is the main question the study is designed to answer.
American College of Rheumatology (ACR) 20 Response Rate
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])
Measured: Week 24
Secondary outcomes (13)
Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score
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.
Measured: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
ACR20 Response Rates Over Time
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])
Measured: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
ACR50 Response Rates Over Time
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])
Measured: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
ACR70 Response Rates Over Time
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])
Measured: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Swollen Joint Count
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.
Measured: Baseline and Week 24
Tender Joint Count
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.
Measured: Baseline and Week 24
Analysis of Serum C-Reactive Protein (CRP) Concentration
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.
Measured: Baseline and Week 24
Patient Assessment of Disease Activity
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.
Measured: Baseline and Week 24
Physician Assessment of Disease Activity
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.
Measured: Baseline and Week 24
Patient's Assessment of Pain
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.
Measured: Baseline and Week 24
Health Assessment Questionnaire Disability Index (HAQ-DI)
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.
Measured: Baseline and Week 24
DAS28-CRP Score Over Time
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.
Measured: Baseline and Week 24
DAS28 Score Based on Erythrocyte Sedimentation Rate (DAS28-ESR)
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.
Measured: Baseline, Week 12 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 728 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujifilm Kyowa Kirin Biologics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Josephine Glover, MD, Principal investigator, Coephycient Pharmaceutical Consultancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260791
- Sponsor's protocol ID
- FKB327-002
- Acronym
- ARABESC
- Status last verified
- Oct 2017
- First submitted
- 29 Jul 2014
- Last updated
- 28 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.
PubMed 33263165Genovese MC, Glover J, Greenwald M, Porawska W, El Khouri EC, Dokoupilova E, Vargas JI, Stanislavchuk M, Kellner H, Baranova E, Matsunaga N, Alten R. FKB327, an adalimumab biosimilar, versus the reference product: results of a randomized, Phase III, double-blind study, and its open-label extension. Arthritis Res Ther. 2019 Dec 12;21(1):281. doi: 10.1186/s13075-019-2046-0.
PubMed 31831079
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety With the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate
- ClinicalTrials.gov ID
- NCT02260791
- Acronym / sponsor ID
- ARABESC / FKB327-002
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Rheumatoid, Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 728 participants (actual)
- Lead sponsor
- Fujifilm Kyowa Kirin Biologics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 9 Oct 2014 (estimated)
- Results
- Posted 20 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FKB327 | Experimental | Drug: FKB327Patients will receive FKB327 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks. |
| Humira® | Active comparator | Drug: Humira®Patients will receive Humira® 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged 18 years or over
- Patients have been diagnosed with Rheumatoid Arthritis (RA) for at least 3 months
- Patient has active RA
- Patient has taken a stable dose of methotrexate for at least 3 months
Key exclusion criteria (5 listed)
- Patient has been previously treated with adalimumab
- Patient has been previously treated or has ongoing treatment with prohibited medications
- Patient has been immunised with a live or attenuated vaccine in past 4 weeks
- Patient has positive result for HIV, HBV, HCV or TB infection
- Other Inclusion/Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FKB327Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks. | Drug | FKB327 |
| Humira®Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks. | Drug | Humira® |
Primary outcome
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])
13 secondary outcomes
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
ACR20 Response Rates Over Time
Time frame: 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
ACR70 Response Rates Over Time
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Swollen Joint Count
Time frame: Baseline and Week 24
Tender Joint Count
Time frame: Baseline and Week 24
Analysis of Serum C-Reactive Protein (CRP) Concentration
Time frame: Baseline and Week 24
Patient Assessment of Disease Activity
Time frame: Baseline and Week 24
Physician Assessment of Disease Activity
Time frame: Baseline and Week 24
Patient's Assessment of Pain
Time frame: Baseline and Week 24
Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: Baseline and Week 24
DAS28-CRP Score Over Time
Time frame: Baseline and Week 24
DAS28 Score Based on Erythrocyte Sedimentation Rate (DAS28-ESR)
Time frame: Baseline, Week 12 and Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33263165Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.
- Derived from this study: PubMed 31831079Genovese MC, Glover J, Greenwald M, Porawska W, El Khouri EC, Dokoupilova E, Vargas JI, Stanislavchuk M, Kellner H, Baranova E, Matsunaga N, Alten R. FKB327, an adalimumab biosimilar, versus the reference product: results of a randomized, Phase III, double-blind study, and its open-label extension. Arthritis Res Ther. 2019 Dec 12;21(1):281. doi: 10.1186/s13075-019-2046-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josephine Glover, MD principal investigator
Coephycient Pharmaceutical Consultancy
100 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FKB327 and Humira® in people with Arthritis, Rheumatoid, run by Fujifilm Kyowa Kirin Biologics Co., Ltd. at 100 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 100 sites in Russia, United States, Ukraine, Poland, Romania and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American College of Rheumatology (ACR) 20 Response Rate (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02260791, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.