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

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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

ClinicalTrials.gov ID

NCT02405780

Acronym / sponsor ID

ARABESC-OLE / FKB327-003

Conditions

Arthritis, Rheumatoid

Keywords

Rheumatoid, Arthritis

Phase

Phase 3

Study type

Interventional

Recruitment status

Completed

Enrolment

645 participants (actual)

Lead sponsor

Fujifilm Kyowa Kirin Biologics Co., Ltd.Industry (pharma, biotech, devices)

Study start

10 Jun 2015 (actual)

Primary completion

18 Jan 2018 (actual)

Study completion

18 Jan 2018 (actual)

First posted

1 Apr 2015 (estimated)

Results

Posted 26 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

None (open label)

Number of arms

2

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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

   Time frame: Period I: from Week 0 up until Week 30;

   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.

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

   Time frame: Period II: from Week 30 up to Week 80

   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.

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

   Time frame: Period I: from Week 0 up until Week 30

   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.

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

   Time frame: Period II: from Week 30 up to Week 80

   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.

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

   Time frame: From Week 0 to Week 80

   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.

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

   Time frame: From Week 0 to Week 80

   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.

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

   Time frame: From Week 0 to Week 80

   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.

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

   Time frame: From Week 0 to Week 80

   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).

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

   Time frame: From Week 0 to Week 80

   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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
• 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.

Related trials for Arthritis, Rheumatoid

• Not yet recruitingObservational study

  The Impact of Rheumatoid Arthritis Treatments on the Modulation of Extracellular Vesicles and Other Biomarkers Involved in the Development of Lung Cancer

  Rheumatoid Arthritis (RA), Lung Neoplasms

• Active, not recruitingPhase 3

  Nipocalimab in Moderate to Severe Sjogren's Disease

  Sjogrens Syndrome

• RecruitingObservational study

  Pain Phenotyping of Rheumatic Diseases - An Observational Study

  Rheumatic Diseases, Lupus Erythematosus, Systemic

• Not yet recruiting

  MYTP01 for Immune-Mediated Diseases

  IgA Nephropathy, Kidney Transplant Recipients

• Not yet recruiting

  Effects of Paraffin Wax Therapy and Dry Cupping on Pain and Wrist Function in Patients With Rheumatoid Arthritis

  Rheumatic Arthritis

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.

92 sites in 11 countries: see every site and its status.