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

March 1, 2019 updated by: Fujifilm Kyowa Kirin Biologics Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
645

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • Ontario
      • 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
      • 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 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
      • Galati, Romania
        • Research Site
    • Bihor
      • Oradea, Bihor, Romania
        • Research Site
    • Covasna
      • Sfantu Gheorghe, Covasna, 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 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, 85381
        • Research Site
    • California
      • Palm Desert, California, United States, 92260
        • Research Site
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Research Site
      • Brandon, Florida, United States, 33511
        • Research Site
      • Jacksonville, Florida, United States, 32207
        • Research Site
      • Miami, Florida, United States, 33135
        • Research Site
      • Sarasota, Florida, United States, 34239
        • Research Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Research Site
    • Michigan
      • Lansing, Michigan, United States, 48910
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27704
        • Research Site
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Research Site
    • Texas
      • Amarillo, Texas, United States, 79124
        • Research Site
      • Austin, Texas, United States, 78745
        • Research Site
      • Mesquite, Texas, United States, 75150
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FKB327
Patients will receive the drug 40 mg every other week by subcutaneous injection. The treatment period may continue for 76 weeks.
Drug: FKB327
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.
Other Names:
  • adalimumab biosimilar
Active Comparator: Humira®
Patients will receive the drug 40 mg every other week by subcutaneous injection. The treatment period may continue for 76 weeks.
Drug: Humira®
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.
Other Names:
  • adalimumab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Period I: from Week 0 up until Week 30;
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.
Period II: from Week 30 up to Week 80
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.
Period I: from Week 0 up until Week 30
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.
Period II: from Week 30 up to Week 80
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.
From Week 0 to Week 80
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.
From Week 0 to Week 80
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.
From Week 0 to Week 80
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).
From Week 0 to Week 80
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.
From Week 0 to Week 80

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Disease Activity Score 28 Based on C Reactive Protein (DAS28 CRP) Score Compared to Baseline as a Measure of Efficacy
Time Frame: From Week 0 of FKB327-002 to Week 80

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).
From Week 0 of FKB327-002 to Week 80
American College of Rheumatology 20 (ACR20) Response Rates From Baseline as a Measure of Efficacy
Time Frame: From Week 0 to Week 80

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%
From Week 0 to Week 80
American College of Rheumatology 50 (ACR50) Response Rates From Baseline as a Measure of Efficacy
Time Frame: From Week 0 to Week 80

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%
From Week 0 to Week 80
American College of Rheumatology 70 (ACR70) Response Rates From Baseline as a Measure of Efficacy
Time Frame: From Week 0 to Week 80

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%
From Week 0 to Week 80

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of Patients Developing Anti-drug Antibodies (ADAs)
Time Frame: From Week 0 to Week 80

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 (%).
From Week 0 to Week 80
Trough Adalimumab Concentration
Time Frame: From Week 0 to Week 80
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.
From Week 0 to Week 80

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fujifilm Kyowa Kirin Biologics Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 18, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 18, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FKB327-003

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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