Rheumatoid ArthritisPhase 3NCT03403140
Long Term Efficacy, Safety and Immunogenicity of Enerceptan in Rheumatoid Arthritis ( GEMENE002 )
A Phase 3 study testing Etanercept in people with Rheumatoid Arthritis, run by Gema Biotech S.A. at 1 site in Argentina.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 99 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Etanercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteArgentina
- Study dates
- 6 Oct 2016to 31 Oct 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
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- 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 :
- 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.
- 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.
- Hospitalization for infection or Subjects who have received antibiotics intravenously within the last month or orally within the last 2 weeks.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Etanercept
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | 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 Receives: Drug: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Infections, hematological disorders,.neurologic disorders and malignancies .
Measured: 72 weeks
Secondary outcomes (11)
Lab tests alterations [Safety and Tolerability]).
Serum Hematological and chemistry values
Measured: 72 weeks
Local reactions [Safety and Tolerability]).
Incidence, description and severity of Local Adverse Drug Reactions
Measured: 72 weeks
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
Measured: 20 and 72 Weeks
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.
Measured: 20 and 72 Weeks
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.
Measured: 20 and 72 Weeks
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
Measured: 20 and 72 Weeks
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.
Measured: 20 and 72 Weeks
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)
Measured: 20 and 72 Weeks
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
Measured: 20 and 72 Weeks
Steady state concentration
Etanercept concentration measure
Measured: 20 and 72 Weeks
Immunogenicity
Antibodies anti-Etanercept measure
Measured: 20 and 72 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start6 Oct 2016
- Primary completion30 Sep 2018 (estimated)
- Study completion31 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gema Biotech S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- QUID Quality in Drugs and Devices Latin American Consulting SRL
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403140
- Sponsor's protocol ID
- GEMENE002
- Status last verified
- Jan 2018
- First submitted
- 30 Nov 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03403140
- Acronym / sponsor ID
- GEMENE002
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- Gema Biotech S.A.Industry (pharma, biotech, devices)
- Collaborators
- QUID Quality in Drugs and Devices Latin American Consulting SRL
- Study start
- 6 Oct 2016 (actual)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 31 Oct 2018 (estimated)
- First posted
- 18 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: EtanerceptEnerceptan®. 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 |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtanerceptEnerceptan®. 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 | Single arm |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Time frame: 72 weeks
Infections, hematological disorders,.neurologic disorders and malignancies .
11 secondary outcomes
Lab tests alterations [Safety and Tolerability]).
Time frame: 72 weeks
Local reactions [Safety and Tolerability]).
Time frame: 72 weeks
ACR20
Time frame: 20 and 72 Weeks
ACR50
Time frame: 20 and 72 Weeks
ACR70
Time frame: 20 and 72 Weeks
DAS (Disease activity state)
Time frame: 20 and 72 Weeks
Change in modified van der Heijde Sharp score
Time frame: 20 and 72 Weeks
Physical function
Time frame: 20 and 72 Weeks
Functional Assessment of Chronic Illness Therapy Fatigue scale (FACIT-Fatigue)
Time frame: 20 and 72 Weeks
Steady state concentration
Time frame: 20 and 72 Weeks
Immunogenicity
Time frame: 20 and 72 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Etanercept in people with Rheumatoid Arthritis, run by Gema Biotech S.A. at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). (time frame: 72 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.