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

Primary Purpose

Rheumatoid Arthritis

Status
Unknown status
Phase
Phase 3
Locations
Argentina
Study Type
Interventional
Intervention
Etanercept
Sponsored by
Gema Biotech S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

19 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Instituto Medico CER

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Lab tests alterations [Safety and Tolerability]).
Serum Hematological and chemistry values
Local reactions [Safety and Tolerability]).
Incidence, description and severity of Local Adverse Drug Reactions
ACR20
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
ACR50
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.
ACR70
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.
DAS (Disease activity state)
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
Change in modified van der Heijde Sharp score
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.
Physical function
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)
Functional Assessment of Chronic Illness Therapy Fatigue scale (FACIT-Fatigue)
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
Steady state concentration
Etanercept concentration measure
Immunogenicity
Antibodies anti-Etanercept measure

Full Information

First Posted
November 30, 2017
Last Updated
January 18, 2018
Sponsor
Gema Biotech S.A.
Collaborators
QUID Quality in Drugs and Devices Latin American Consulting SRL
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1. Study Identification

Unique Protocol Identification Number
NCT03403140
Brief Title
Long Term Efficacy, Safety and Immunogenicity of Enerceptan in Rheumatoid Arthritis ( GEMENE002 )
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 6, 2016 (Actual)
Primary Completion Date
September 30, 2018 (Anticipated)
Study Completion Date
October 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gema Biotech S.A.
Collaborators
QUID Quality in Drugs and Devices Latin American Consulting SRL

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
141 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Etanercept
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Description
Infections, hematological disorders,.neurologic disorders and malignancies .
Time Frame
72 weeks
Secondary Outcome Measure Information:
Title
Lab tests alterations [Safety and Tolerability]).
Description
Serum Hematological and chemistry values
Time Frame
72 weeks
Title
Local reactions [Safety and Tolerability]).
Description
Incidence, description and severity of Local Adverse Drug Reactions
Time Frame
72 weeks
Title
ACR20
Description
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
Time Frame
20 and 72 Weeks
Title
ACR50
Description
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.
Time Frame
20 and 72 Weeks
Title
ACR70
Description
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.
Time Frame
20 and 72 Weeks
Title
DAS (Disease activity state)
Description
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
Time Frame
20 and 72 Weeks
Title
Change in modified van der Heijde Sharp score
Description
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.
Time Frame
20 and 72 Weeks
Title
Physical function
Description
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)
Time Frame
20 and 72 Weeks
Title
Functional Assessment of Chronic Illness Therapy Fatigue scale (FACIT-Fatigue)
Description
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
Time Frame
20 and 72 Weeks
Title
Steady state concentration
Description
Etanercept concentration measure
Time Frame
20 and 72 Weeks
Title
Immunogenicity
Description
Antibodies anti-Etanercept measure
Time Frame
20 and 72 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having completed the final active treatment visit of the GEMENE001 study, the same day or within 28 days prior to entry in this study. 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 Informed consent must be signed before making any study-specific procedure Exclusion Criteria: 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. Simultaneous treatment with other investigational drug or participation in another clinical study that the investigator considers inadvisable. Women who are pregnant or breastfeeding. History of lack of response or loss of response to previous therapy with Etanercept in the GEMENE001 study. Chronic antibiotic therapy, if the investigator considers this may affect the safety of the subject or the assessment of the study results. 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: Administration of vaccines: 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.) Subjects who have received the BCG vaccine within the GEMENE001 study 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. Past history of drug or alcohol abuse within the study GEMENE001. Any condition that, in the investigator's opinion, would not allow compliance with the guidelines of the study by the patient.
Facility Information:
Facility Name
Instituto Medico CER
City
Bs As
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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