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A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients (ARABESC-OLE)

Primary Purpose

Arthritis, Rheumatoid

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

FKB327

Humira®

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Rheumatoid, Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient has completed the Week 24 visit procedures of Study FKB327-002 (NCT02260791) and are continuing with methotrexate
In the investigator's opinion, the patient showed a clinical response to treatment during Study FKB327-002 (NCT02260791)

Exclusion Criteria:

Patient has evidence of a serious adverse event (SAE) ongoing from Study FKB327-002
Patient has presence of active and/or untreated latent tuberculosis (TB)

Other Inclusion/Exclusion criteria may apply.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FKB327

Humira®

Arm Description

Patients will receive the drug 40 mg every other week by subcutaneous injection. The treatment period may continue for 76 weeks.

Outcomes

Primary Outcome Measures

Number of Patients With Adverse Events as a Measure of Safety Per Treatment Group in Period I

Period I: Patients were carefully monitor for Adverse Events from signing of informed consent until week 30 and thereafter during Period II of the study. For patients who discontinued early, a follow-up period of 4 weeks was added to the Early Termination Visit. The investigator actively asked the patients for Adverse Events. Patients spontaneously reported Adverse Events to the Investigator during clinic visits or in between visits.

Number of Patients With Adverse Events as a Measure of Safety in Period II - Single Treatment Period

From week 30 all subjects were transferred to receive FKB327 treatment. Adverse Events were contentiously monitored and recorded during Period II. For patients discontinuing the study prematurely, a follow-up period of 4 weeks was added to the Early Termination Visit. The data for Period II is based on the number of patients in the Safety Analysis Set that entered Period II.

Number of Patients With Serious Adverse Events as a Measure of Safety Per Treatment Group in Period I

A Serious Adverse Event (SAE) was defined in the Protocol as: Death; or a Life-threatening Adverse Event (AE); Inpatient Hospitalization; Persistant or significant disability or incapacity; A congenital anomaly/birth defect; An important medical event that may not have resulted in death, have been life-threatening, or required hospitalization, but may have jeopardized the patient and may have required medical intervention to prevent 1 of the outcomes listed in this definition. SAEs were followed until resolution, the investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.

Number of Patients With Serious Adverse Events as a Measure of Safety in Period II - Single Treatment Period

Period II: at week 30 all patients were transferred to receive FKB327. Each subject was counted once within each System Organ Class (SOC) and Preferred Term (PT). Death defined as a fatal outcome of a (S)AE. SAEs were followed until resolution, the investigator confirmed the event was unlikely to resolve or the patient was lost to follow-up.

Changes in Vital Signs as a Measure of Safety - Systolic Blood Pressure

Systolic Blood Pressure is part of Vital Signs which were part of the subject safety evaluations. Systolic Blood Pressure was measured at the following time-points: Week 0, Week 4, Week 8, Week 12, Week 24 and Week 80/End o Study (EOS). Systolic Blood Pressure with changes from Baseline_002 (NCT022600791) was summarized by treatment sequence over the whole study period for each visit. Baseline_002 is defined as the last non-missing measurement collected prior to the first study medication administered at Week 0 from Study FKB327-002.

Changes in Vital Signs as a Measure of Safety - Diastolic Blood Pressure

Diastolic Blood Pressure is part of Vital Signs which were part of the subject safety evaluations. Diastolic Blood Pressure was measured at the following time-points: Week 0, Week 4, Week 8, Week 12, Week 24 and Week 80/End o Study (EOS). Diastolic Blood Pressure with changes from Baseline_002 (NCT022600791) was summarized by treatment sequence over the whole study period for each visit measured. Baseline_002 is defined as the last non-missing measurement collected prior to the first study medication administered at Week 0 from Study FKB327-002.

Changes in Vital Signs as a Measure of Safety - Pulse Rate

Pulse rate is part of Vital Signs which were part of the subject safety evaluations. Pulse rate was measured at the following time-points: Weeks 0, 4, 8, 12, 24 and 80/End of Study (EOS). Pulse Rate with changes from Baseline_002 (NCT022600791) was summarized by treatment sequence over the whole study period for each visit. Baseline_002 is defined as the last non-missing measurement collected prior to the first study medication administered at Week 0 from Study FKB327-002.

Changes in Vital Signs as a Measure of Safety - Temperature Measurements

Temperature measurements forms part of the vital signs which was one of the continuous safety measurements for the study primary endpoint. Temperature was measured at week 0, week 4, week 8, week 12, week 24 and at week 80 or at End of Study (EOS). Temperature with change from Baseline_002 were summarized by treatment sequence over the whole study period. Baseline_002 is defined as the last non-missing measurement collected prior to the first study medication administration at Week 0 from Study FKB327-002 (NCT02260791).

Summary of Most Common Clinical Significant Laboratory Parameters Reported as Adverse Events (Reported by ≥1% of the Patients)

Clinical Laboratory tests for hematology and serum chemistry were performed by the sites and analysed at a Central Laboratory. Urine dip-stick tests were performed by the sites. Laboratory samples were taken at the following time-points (weeks): 0; 4; 8; 12; 24; 30; 42; 54; 66; 76 and 80/End of Study (EOS). Each result outside its normal range was review and assessed by the investigator whether or not it was Clinically Significant (CS) or Not Clinically Significant (NCS) CS laboratory abnormalities were recorded as AEs.

Secondary Outcome Measures

Changes in Disease Activity Score 28 Based on C Reactive Protein (DAS28 CRP) Score Compared to Baseline as a Measure of Efficacy

The DAS28 score is a combined index that has been developed to measure the disease activity in patients with Rheumatoid arthritis (RA) and has been extensively validated for the use in clinical studies. The DAS28-CRP assessment involved evaluating the number of tender (TJC) and the swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (Visual analogue scale (VAS) from 0-100, very well to extremely bad). The individual results are summarized using a formula. 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. During the FKB327-003 study for Period I and Period II the DAS28-CRP score was compared to Baseline in study FKB327-002 (NCT02260791).

American College of Rheumatology 20 (ACR20) Response Rates From Baseline as a Measure of Efficacy

An ACR20 response means that the patient achieved a 20% improvement in Tender Joint Count (TJC) and Swollen Joint Count (SJC) and a 20% improvement in at least 3 of the other 5 Core Data Set elements listed below: Acute phase reactant (C-reactive protein, CRP) A high level of CRP in the blood is a marker of inflammation. Patient global assessment of disease activity assessed on a Visual Analog Scale (VAS) ranging from very well to extremely bad was assessed on a 100 point scale. (from 0 to 100) Physician global assessment of disease activity assessed on a VAS ranging from very low to very high was assessed on 100 point scale Patient pain scale assessed on a VAS ranging from very well to extremely bad was assessed on 100 point scale Disability/functional questionnaire (patient completed Heath Assessment Questionnaire Disability Index (HAQ-DI)) A higher response rate is a better outcome. The minimum possible value is 0% and the maximum possible value is 100%

American College of Rheumatology 50 (ACR50) Response Rates From Baseline as a Measure of Efficacy

An ACR50 response means that the patient achieved a 50% improvement in Tender Joint Count (TJC) and Swollen Joint Count (SJC) and in at least 3 of the other 5 Core Data Set elements listed below: Acute phase reactant (C-reactive protein, CRP) A high level of CRP in the blood is a marker of inflammation. Patient global assessment of disease activity assessed on a Visual Analog Scale (VAS) ranging from very well to extremely bad was assessed on a 100 point scale. (from 0 to 100) Physician global assessment of disease activity assessed on a VAS ranging from very low to very high was assessed on 100 point scale Patient pain scale assessed on a VAS ranging from very well to extremely bad was assessed on 100 point scale Disability/functional questionnaire (patient completed Heath Assessment Questionnaire Disability Index (HAQ-DI)) A higher response rate is a better outcome. The minimum possible value is 0% and the maximum possible value is 100%

American College of Rheumatology 70 (ACR70) Response Rates From Baseline as a Measure of Efficacy

An ACR70 response means that the patient achieved a 70% improvement in Tender Joint Count (TJC) and Swollen Joint Count (SJC) and in at least 3 of the other 5 Core Data Set elements listed below: Acute phase reactant (C-reactive protein,CRP) A high level of CRP in the blood is a marker of inflammation. Patient global assessment of disease activity assessed on a Visual Analog Scale (VAS) ranging from very well to extremely bad was assessed on a 100 point scale. (from 0 to 100) Physician global assessment of disease activity assessed on a VAS ranging from very low to very high was assessed on 100 point scale Patient pain scale assessed on a VAS ranging from very well to extremely bad was assessed on 100 point scale Disability/functional questionnaire (patient completed Heath Assessment Questionnaire Disability Index (HAQ-DI)) A higher response rate is a better outcome. The minimum possible value is 0% and the maximum possible value is 100%

Full Information

NCT ID

NCT02405780

First Posted

March 17, 2015

Last Updated

March 1, 2019

Sponsor

Fujifilm Kyowa Kirin Biologics Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02405780

Brief Title

A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients

Acronym

ARABESC-OLE

Official Title

An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients With Rheumatoid Arthritis on Concomitant Methotrexate

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

June 10, 2015 (Actual)

Primary Completion Date

January 18, 2018 (Actual)

Study Completion Date

January 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fujifilm Kyowa Kirin Biologics Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the study is to compare the long-term safety, effectiveness and immunogenicity of FKB327 in comparison to Humira® in rheumatoid arthritis patients who have completed study FKB327-002 and have inadequate disease control on methotrexate.

Detailed Description

The first period of this extension study was an open label, randomised, comparative, multi centre, 2 arm extension Phase 3 study in patients with RA who were taking a stable dose of MTX and who had continued from the preceding Study FKB327-002 (NCT02260791). The transition from Study FKB327-002 was ideally to occur without interruption: the Week 24 visit of Study FKB327-002 was to be on the same day as the Week 0 visit of Study FKB327-003. Patients who had received FKB327 in Study FKB327-002 received FKB327 or Humira in a 2:1 ratio and patients who had received Humira in Study FKB327-002 received Humira or FKB327 in a 2:1 ratio (Period I). The second period of the study was an open label, single arm extension in which all patients received FKB327 treatment from Week 30 to Week 76 (Period II), followed by a 4 week Follow up period. Clinic visits were scheduled for Weeks 0, 2, 4, 8, 12, 24, 30, 32, 34, 42, 54, 66, 76, and 80. The patient or carer was allowed to administer interim doses of study drug at home every other week (eow) between clinic visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthritis, Rheumatoid

Keywords

Rheumatoid, Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

645 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FKB327

Arm Type

Experimental

Arm Description

Patients will receive the drug 40 mg every other week by subcutaneous injection. The treatment period may continue for 76 weeks.

Arm Title

Humira®

Arm Type

Active Comparator

Arm Description

Patients will receive the drug 40 mg every other week by subcutaneous injection. The treatment period may continue for 76 weeks.

Intervention Type

Drug

Intervention Name(s)

FKB327

Other Intervention Name(s)

adalimumab biosimilar

Intervention Description

Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 28 weeks. Patients may continue to receive FKB327 40 mg every other week by subcutaneous injection for up to 76 weeks.

Intervention Type

Drug

Intervention Name(s)

Humira®

Other Intervention Name(s)

adalimumab

Intervention Description

Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 28 weeks. Patients may then receive FKB327 40 mg every other week by subcutaneous injection from week 30 to week 76.

Primary Outcome Measure Information:

Title

Number of Patients With Adverse Events as a Measure of Safety Per Treatment Group in Period I

Description

Time Frame

Period I: from Week 0 up until Week 30;

Title

Number of Patients With Adverse Events as a Measure of Safety in Period II - Single Treatment Period

Description

Time Frame

Period II: from Week 30 up to Week 80

Title

Number of Patients With Serious Adverse Events as a Measure of Safety Per Treatment Group in Period I

Description

Time Frame

Period I: from Week 0 up until Week 30

Title

Number of Patients With Serious Adverse Events as a Measure of Safety in Period II - Single Treatment Period

Description

Time Frame

Period II: from Week 30 up to Week 80

Title

Changes in Vital Signs as a Measure of Safety - Systolic Blood Pressure

Description

Time Frame

From Week 0 to Week 80

Title

Changes in Vital Signs as a Measure of Safety - Diastolic Blood Pressure

Description

Time Frame

From Week 0 to Week 80

Title

Changes in Vital Signs as a Measure of Safety - Pulse Rate

Description

Time Frame

From Week 0 to Week 80

Title

Changes in Vital Signs as a Measure of Safety - Temperature Measurements

Description

Time Frame

From Week 0 to Week 80

Title

Summary of Most Common Clinical Significant Laboratory Parameters Reported as Adverse Events (Reported by ≥1% of the Patients)

Description

Time Frame

From Week 0 to Week 80

Secondary Outcome Measure Information:

Title

Changes in Disease Activity Score 28 Based on C Reactive Protein (DAS28 CRP) Score Compared to Baseline as a Measure of Efficacy

Description

Time Frame

From Week 0 of FKB327-002 to Week 80

Title

American College of Rheumatology 20 (ACR20) Response Rates From Baseline as a Measure of Efficacy

Description

Time Frame

From Week 0 to Week 80

Title

American College of Rheumatology 50 (ACR50) Response Rates From Baseline as a Measure of Efficacy

Description

Time Frame

From Week 0 to Week 80

Title

American College of Rheumatology 70 (ACR70) Response Rates From Baseline as a Measure of Efficacy

Description

Time Frame

From Week 0 to Week 80

Other Pre-specified Outcome Measures:

Title

Proportion of Patients Developing Anti-drug Antibodies (ADAs)

Description

Blood samples for assessment of Anti-Drug antibodies (ADA) were collected prior to dosing (trough samples) at Baseline (Week 0) and at Weeks 12, 24, 30, 54, 76 and 80/EOS. All ADA activity was listed and summarized for each treatment sequence by time point during the overall treatment period as well as by treatment group for each period (Period I and Period II). Descriptive statistics included absolute counts (n) and percentage (%).

Time Frame

From Week 0 to Week 80

Title

Trough Adalimumab Concentration

Description

Blood samples for the quantification of adalimumab concentration in serum were collected prior to dosing (trough samples) at Baseline (Week 0), and at weeks 12, 24 , 30, 54, 76 and 80/EOS.

Time Frame

From Week 0 to Week 80

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient has completed the Week 24 visit procedures of Study FKB327-002 (NCT02260791) and are continuing with methotrexate In the investigator's opinion, the patient showed a clinical response to treatment during Study FKB327-002 (NCT02260791) Exclusion Criteria: Patient has evidence of a serious adverse event (SAE) ongoing from Study FKB327-002 Patient has presence of active and/or untreated latent tuberculosis (TB) Other Inclusion/Exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Josephine Glover, MD

Organizational Affiliation

Coephycient Pharmaceutical Consultancy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

Research Site

City

Palm Desert

State/Province

California

ZIP/Postal Code

92260

Country

United States

Facility Name

Research Site

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Facility Name

Research Site

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

Facility Name

Research Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32207

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Facility Name

Research Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Research Site

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71101

Country

United States

Facility Name

Research Site

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48910

Country

United States

Facility Name

Research Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27704

Country

United States

Facility Name

Research Site

City

Middleburg Heights

State/Province

Ohio

ZIP/Postal Code

44130

Country

United States

Facility Name

Research Site

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Research Site

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79124

Country

United States

Facility Name

Research Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78745

Country

United States

Facility Name

Research Site

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75150

Country

United States

Facility Name

Research Site

City

St. Catherines

State/Province

Ontario

Country

Canada

Facility Name

Research Site

City

Trois-Rivieres

State/Province

Quebec

Country

Canada

Facility Name

Research Site

City

Osorno

Country

Chile

Facility Name

Research Site

City

Puerto Varas

Country

Chile

Facility Name

Research Site G

City

Santiago

Country

Chile

Facility Name

Research Site M

City

Santiago

Country

Chile

Facility Name

Research Site

City

Temuco

Country

Chile

Facility Name

Research Site

City

Brno

Country

Czechia

Facility Name

Research Site

City

Hlucin

Country

Czechia

Facility Name

Research Site U

City

Prague

Country

Czechia

Facility Name

Research Site

City

Prague

Country

Czechia

Facility Name

Research Site

City

Uherske Hradiste

Country

Czechia

Facility Name

Research Site

City

Zlin

Country

Czechia

Facility Name

Research Site

City

Aachen

Country

Germany

Facility Name

Research Site

City

Berlin

Country

Germany

Facility Name

Research Site

City

Hamburg

Country

Germany

Facility Name

Research Site

City

Munich

Country

Germany

Facility Name

Research Site

City

Ratingen

Country

Germany

Facility Name

Research Site B

City

Arequipa

Country

Peru

Facility Name

Research Site M

City

Arequipa

Country

Peru

Facility Name

Research Site CA

City

Lima

Country

Peru

Facility Name

Research Site CH

City

Lima

Country

Peru

Facility Name

Research Site PA

City

Lima

Country

Peru

Facility Name

Research Site S

City

Lima

Country

Peru

Facility Name

Research Site D

City

Bialystok

Country

Poland

Facility Name

Research Site R

City

Bialystok

Country

Poland

Facility Name

Research Site

City

Gdynia

Country

Poland

Facility Name

Research Site

City

Katowice

Country

Poland

Facility Name

Research Site KL

City

Krakow

Country

Poland

Facility Name

Research Site KR

City

Krakow

Country

Poland

Facility Name

Research Site

City

Lublin

Country

Poland

Facility Name

Research Site P

City

Poznan

Country

Poland

Facility Name

Research Site RH

City

Poznan

Country

Poland

Facility Name

Research Site

City

Torun

Country

Poland

Facility Name

Research Site

City

Oradea

State/Province

Bihor

Country

Romania

Facility Name

Research Site

City

Sfantu Gheorghe

State/Province

Covasna

Country

Romania

Facility Name

Research Site

City

Braila

Country

Romania

Facility Name

Research Site

City

Brasov

Country

Romania

Facility Name

Research Site C

City

Bucharest

Country

Romania

Facility Name

Research Site R

City

Bucharest

Country

Romania

Facility Name

Research Site T

City

Bucharest

Country

Romania

Facility Name

Research Site

City

Galati

Country

Romania

Facility Name

Research Site

City

Ufa

State/Province

Bashkortostan Republic

Country

Russian Federation

Facility Name

Research Site

City

Petrozavodsk

State/Province

Karelia Republic

Country

Russian Federation

Facility Name

Research Site

City

Kazan

State/Province

Tatarstan Republic

Country

Russian Federation

Facility Name

Research Site D

City

Moscow

Country

Russian Federation

Facility Name

Research Site SM

City

Moscow

Country

Russian Federation

Facility Name

Research Site ST

City

Moscow

Country

Russian Federation

Facility Name

Research Site

City

Nizhny Novgorod

Country

Russian Federation

Facility Name

Research Site

City

Penza

Country

Russian Federation

Facility Name

Research Site

City

Perm

Country

Russian Federation

Facility Name

Research Site

City

Ryazan

Country

Russian Federation

Facility Name

Research Site B

City

Saint-Petersburg

Country

Russian Federation

Facility Name

Research Site Z

City

Saint-Petersburg

Country

Russian Federation

Facility Name

Research Site

City

Saratov

Country

Russian Federation

Facility Name

Research Site

City

Smolensk

Country

Russian Federation

Facility Name

Research Site

City

Vladimir

Country

Russian Federation

Facility Name

Research Site E

City

Yaroslavl

Country

Russian Federation

Facility Name

Research Site S

City

Yaroslavl

Country

Russian Federation

Facility Name

Research Site

City

Santiago de Compostela

State/Province

La Coruna

Country

Spain

Facility Name

Research Site

City

Bilbao

State/Province

Vizcaya

Country

Spain

Facility Name

Research Site G

City

Barcelona

Country

Spain

Facility Name

Research Site

City

Malaga

Country

Spain

Facility Name

Research Site

City

Chernivtsi

Country

Ukraine

Facility Name

Research Site

City

Ivano-Frankivsk

Country

Ukraine

Facility Name

Research Site A

City

Kyiv

Country

Ukraine

Facility Name

Research Site B

City

Kyiv

Country

Ukraine

Facility Name

Research Site P

City

Kyiv

Country

Ukraine

Facility Name

Research Site

City

Lutsk

Country

Ukraine

Facility Name

Research Site C

City

Lviv

Country

Ukraine

Facility Name

Research Site N

City

Lviv

Country

Ukraine

Facility Name

Research Site

City

Poltava

Country

Ukraine

Facility Name

Research Site

City

Ternopil

Country

Ukraine

Facility Name

Research Site

City

Uzhgorod

Country

Ukraine

Facility Name

Research Site G

City

Vinnytsia

Country

Ukraine

Facility Name

Research Site Sh

City

Vinnytsia

Country

Ukraine

Facility Name

Research Site St

City

Vinnytsia

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

33263165

Citation

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.

Results Reference

derived

PubMed Identifier

31831079

Citation

Genovese 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.

Results Reference

derived

Learn more about this trial

A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients

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A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients (ARABESC-OLE)

Arthritis, Rheumatoid

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial