Long Term Efficacy, Safety and Immunogenicity of Enerceptan in Rheumatoid Arthritis ( GEMENE002 )

January 18, 2018 updated by: Gema Biotech S.A.

Multicenter Extension Study To 104 Weeks To Asses The Efficacy, Safety And Immunogenicity Of Enerceptan® In Combination With Methotrexate For The Treatment Of Patients With Rheumatoid Arthritis

The purpose of this study is to asses the long term efficacy, safety and immunogenicity of ENERCEPTAN® in combination with Methotrexate for the treatment of patients with rheumatoid arthritis up to 104 weeks

Study Overview

Status

Status

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

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

This is a prospective study, single treatment arm of 72 weeks of duration. Patients who completed the original study GEMENE001 may enroll in the study.

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 (Anticipated)

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.
141

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

  • Argentina
      • Bs As, Argentina
        • Instituto Medico CER

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

19 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Having completed the final active treatment visit of the GEMENE001 study, the same day or within 28 days prior to entry in this study.
  2. Women of childbearing age must commit to be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of Enerceptan®. Suitable methods of contraception are oral contraceptives, IUDs, bilateral tubal ligation, vasectomy or double barrier methods such as condoms or spermicidal diaphragm, sponge, contraceptive foam or gel, heterosexual abstinence. Men should not conceive up to 12 weeks after stopping the MTX
  3. Informed consent must be signed before making any study-specific procedure

Exclusion Criteria:

  1. Have temporarily interrupted the investigational product in the final study visit GEMENE001 and, according to the investigator's opinion, this represents an unacceptable risk to the patient whether this participates in the GEMENE002 study.
  2. Simultaneous treatment with other investigational drug or participation in another clinical study that the investigator considers inadvisable.
  3. Women who are pregnant or breastfeeding.
  4. History of lack of response or loss of response to previous therapy with Etanercept in the GEMENE001 study.
  5. Chronic antibiotic therapy, if the investigator considers this may affect the safety of the subject or the assessment of the study results.
  6. Any previous or current serious medical conditions which had appeared during the study GEMENE001 that, in the opinion of the investigator, constitute a contraindication for the study treatment, as:

  7. Administration of vaccines:

    1. Subjects who have received a live attenuated vaccine within 3 months prior to the selection Visit (for example, varicella-zoster, oral polio, rabies, yellow fever vaccines.)
    2. Subjects who have received the BCG vaccine within the GEMENE001 study

  8. Presence of :

    a. At the time of the inclusion i. Active infections. ii. Fever (≥38 °C) or active, chronic or recurrent infections that require treatment with antibiotics, antiviral, or anti-fungal drugs within 4 weeks prior to Screening Visit, or history of frequent recurrent infections unacceptable to the investigator's opinion.

    iii. Non-healing infected skin ulcers. b. In the previous time: i. Background of recurrent bacterial, viral, fungal (excluding superficial infections or nail bed mycosis), mycobacterial or other severe infections within the last month previous to selection.

    ii. Hospitalization for infection or Subjects who have received antibiotics intravenously within the last month or orally within the last 2 weeks.

    iii. Subjects with herpes zoster in the last 2 months.

  9. Past history of drug or alcohol abuse within the study GEMENE001.
  10. Any condition that, in the investigator's opinion, would not allow compliance with the guidelines of the study by the patient.

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: N/A
  • Interventional Model: Single Group 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: Single arm

Enerceptan®. Injectable Solution in prefilled syringes

Source: GEMABIOTECH S. A. Formulation per unit:

1,0 ml of Enerceptan® contains 50 mg solution of Etanercept /Once a week Methotrexate 15 to 25 mg / Once a week
Drug: Etanercept

Enerceptan®. Injectable Solution in prefilled syringes

Source: GEMABIOTECH S. A. Formulation per unit:

1,0 ml of Enerceptan® contains 50 mg solution of Etanercept /Once a week Methotrexate 15 to 25 mg / Once a week

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
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Time Frame: 72 weeks
Infections, hematological disorders,.neurologic disorders and malignancies .
72 weeks

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
Lab tests alterations [Safety and Tolerability]).
Time Frame: 72 weeks
Serum Hematological and chemistry values
72 weeks
Local reactions [Safety and Tolerability]).
Time Frame: 72 weeks
Incidence, description and severity of Local Adverse Drug Reactions
72 weeks
ACR20
Time Frame: 20 and 72 Weeks

ACR (American College of Rheumatology) 20 The percentage of patients who achieved ACR20 at Week 32 is the primary end point. Signs and symptoms are assessed with a composite rating scale of the ACR (American College of

Rheumatology) that includes 7 variables:

  • Tender Joints Count
  • Swollen Joints Count
  • Levels of an acute phase reactant (CRP level)
  • Patient's assessment of pain
  • Patient's global assessment of disease activity
  • Physician's global assessment of disease activity
  • Patient's assessment of physical function
20 and 72 Weeks
ACR50
Time Frame: 20 and 72 Weeks
ACR50 is defined as the percentage of patients who achieve at least 50% improvement in both tender joint count and swollen joint count, and at least 50% improvement in at least 3 of the 5 other assessments.
20 and 72 Weeks
ACR70
Time Frame: 20 and 72 Weeks
ACR70 is defined as the percentage of patients who achieve at least 70% improvement in both tender joint count and swollen joint count, and at least 50% improvement in at least 3 of the 5 other assessments.
20 and 72 Weeks
DAS (Disease activity state)
Time Frame: 20 and 72 Weeks

It will be measured using the DAS (Disease activity state) 28. DAS28 is a composite score that includes 4 variables:

  • Tender Joints Count (based on 28 joints)
  • Swollen Joints Count (based on 28 joints)
  • Patient's global assessment of disease activity
  • Marker of inflammation: C REACTIVE PROTEIN
20 and 72 Weeks
Change in modified van der Heijde Sharp score
Time Frame: 20 and 72 Weeks

The Sharp method is a composite X-ray scoring system used to assess structural (joint) disease progression in rheumatoid arthritis. The method evaluates both joint erosions (JE) and joint space narrowing (JSN) in bilateral hand and foot joints. The Sharp/van der Heijde method assesses erosions and joint space narrowing separately in the hands and feet, and has a range from 0 to 448. Thirty-two joints in the hands and 12 in the feet are scored for erosions, with a maximum score of five per joint in the hands and 10 per joint in the feet. Joint space narrowing is graded from 0 to 4 in 30 joints in the hands and in 12 joints in the feet.

The principal score used in the analyses is the total score, which is the sum of the erosion score and the joint space narrowing score.
20 and 72 Weeks
Physical function
Time Frame: 20 and 72 Weeks

Improvement in physical function is assessed by change from baseline in HAQ (Health Assessment Questionnaire).The HAQ-DI (disability index) is composed of 8 categories as follows: dressing and grooming, arising, eating, walking, hygiene, reach, grip and activities, for which there are at least 2 questions by category. The patient will be asked to score how difficult he/she feels it is to perform such activities using a 0 to 3 scoring (0=without any difficulty,

1=with some difficulty, 2=with much difficulty and 3=unable to do). If the patient is using assistance for any of these activities, scoring may be adjusted. For each category, the highest score given for one of the question is attributed to the category. The total score is the sum of all categories' scores divided by the number of answered categories (at least 3 categories should be answered)
20 and 72 Weeks
Functional Assessment of Chronic Illness Therapy Fatigue scale (FACIT-Fatigue)
Time Frame: 20 and 72 Weeks

The FACIT-Fatigue is a 13-item questionnaire rated 0 to 4. The patient will be asked to answer to 13 questions rated 0 to 4 (0=not at all,

1=a little bit, 2=some what, 3=quite a bit, 4=very much
20 and 72 Weeks
Steady state concentration
Time Frame: 20 and 72 Weeks
Etanercept concentration measure
20 and 72 Weeks
Immunogenicity
Time Frame: 20 and 72 Weeks
Antibodies anti-Etanercept measure
20 and 72 Weeks

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.
Gema Biotech S.A.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
QUID Quality in Drugs and Devices Latin American Consulting SRL

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.
October 6, 2016

Primary Completion (Anticipated)

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.
September 30, 2018

Study Completion (Anticipated)

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.
October 31, 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).
November 30, 2017

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.
January 10, 2018

First Posted (Actual)

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.
January 18, 2018

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.
January 23, 2018

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.
January 18, 2018

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.
January 1, 2018

More Information

Terms related to this study

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.
  • GEMENE002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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