Efficacy, Safety and Immunogenicity of Enerceptan Compared to Enbrel in Rheumatoid Arthritis
NCT ID: NCT03332719
Last Updated: 2017-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
168 participants
INTERVENTIONAL
2016-02-29
2017-09-30
Brief Summary
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Detailed Description
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Subjects should be with inadequate response to methotrexate with stable dosis ≥ 15 and ≤ 25 mg/week 28 days before randomization.
Randomization will be 2:1 Enerceptan® to Enbrel® with concomitant medication of MTX
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Enbrel®
Enbrel® 50 mg injectable solution in autoinjector SureClick® contains: 50 mg etanercept and excipients/Once a week Methotrexate 15 to 25 mg /Once a week
Etanercept
Methotrexate
Enerceptan®.
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
Etanercept
Methotrexate
Interventions
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Etanercept
Methotrexate
Eligibility Criteria
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Inclusion Criteria
2. Moderate to severe disease activity, according to DAS28 (erythrosedimentation) ≥ 3.2.
3. Must have at least a minimum of 6 tender joints and 8 swollen joints. If a patient has a joint surgery prior to the study, this joint is considered not evaluable throughout the study development.
4. Must have at least, one erosion in the baseline radiograph. Local assessment centers either radiologist or rheumatologist to decide on this criterion will be accepted.
5. Medical Indication to incorporate a biological treatment in their therapy.
6. Treatment with MTX for at least 3 months on dose ≥15 mg/ week, stable over the last 28 days before the Day 1. Doses lower than 15 mg and greater or equal than 10 mg/ week are accepted in cases with previously documented intolerance.
7. Subjects who have previously received treatment with a biologic (approved or investigational) except etanercept, may participate as long as the corresponding washout time has elapsed prior to the screening interview: At least
1. 8 weeks for infliximab (T1/2 8 to 9.5 days) and for tocilizumab (T1/2 3to 12 days)
2. 10 weeks for adalimumab (T1/2 10 to 20 days), Golimumab (T1/2 11 to 14 days), certolizumab (T1/2 14 days), abatacept (T1/2 14 days),
3. 1 year for Rituximab (T1/2 77,5 days)
4. 5 T1/2 for any other biological product, used for the treatment of rheumatoid arthritis, wether it has been used or not for research.
5. Subjects who are receiving leflunomide must have a previous washout of 8 weeks before Day 1, except had have treatment with colestyramine, according to manufacturer indications.
6. Can receive non steroidal anti inflammatory drugs (NSAIDs) or oral corticoids in doses \< 10 mg of prednisone, but treatment must have been stable over the last 28 days.
8 Subjects must be able to self-inject or willing to have a previously assigned caregiver do it for them.
9 Subjects must be able to meet the schedule of visits, understand and comply with other protocol requirements.
10 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 Enbrel®/Enerceptan®. Suitable methods of contraception are oral contraceptives, IUDs (intrauterine device) , 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
11 Informed consent must be signed before making any study-specific procedure.
Exclusion Criteria
2. Women who are pregnant or breastfeeding.
3. Past history of nonresponsive to TNF (tumor necrosis factor) blocking agents or other biologic treatment.
4. Chronic antibiotic therapy, if the investigator considers this may affect the safety of the subject or the assessment of the study results.
5. Any previous or current serious medical conditions that, in the opinion of the investigator, constitute a contraindication for the study treatment, as:
6. Administration of vaccines:
1. Subjects who have received a live attenuated vaccine within 3 months prior to the randomization Visit (for example, varicella-zoster, oral polio, rabies, yellow fever vaccines.)
2. Subjects who have received the BCG (bacillus Calmette-Guerin) vaccine within 12 months before the Selection.
7. 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 medications 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.
8. Past history of drug or alcohol abuse within the last year prior to the Screening Visit.
9. Known hypersensitivity to the study drug or history of severe allergy or anaphylactic reaction to monoclonal antibodies or fusion or human proteins.
10. Any condition that, in the investigator opinion, would not allow compliance with the guidelines of the study by the patient.
11. The subject presents absolute contraindications for the use of etanercept, according to the prospectus
12. Presence of significant laboratory abnormalities in the screening visit.
19 Years
99 Years
ALL
No
Sponsors
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QUID Quality in Drugs and Devices Latin American Consulting SRL
OTHER
Gema Biotech S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Jorge Velasco, MD
Role: PRINCIPAL_INVESTIGATOR
Instituto Médico CER
Maria de los Angeles Correa, MD
Role: PRINCIPAL_INVESTIGATOR
PAMPA
Maria Alicia Lazaro, MD
Role: PRINCIPAL_INVESTIGATOR
IARI
Rodolfo Pardo Hidalgo, MD
Role: PRINCIPAL_INVESTIGATOR
CER San Juan
Daniel Siri, MD
Role: PRINCIPAL_INVESTIGATOR
CAICI
Alberto Jorge Spindler, MD
Role: PRINCIPAL_INVESTIGATOR
Centro Médico Privado de Reumatología
Ingrid Strusberg, MD
Role: PRINCIPAL_INVESTIGATOR
Centro Reumatologico Strusberg
Patricio Tate, MD
Role: PRINCIPAL_INVESTIGATOR
OMI
Horacio Oscar Venarotti, MD
Role: PRINCIPAL_INVESTIGATOR
Atención Integral en Reumatología
Locations
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Instituto Medico CER
Bs As, , Argentina
Countries
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References
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Strusberg I, Mysler E, Citera G, Siri D, de Los Angeles Correa M, Lazaro MA, Pardo Hidalgo R, Spindler A, Tate P, Venarotti H, Velasco Zamora J, Klimovsky E, Federico A, Scheines E, Gonzalez E, Cordeiro L, Lago N. Efficacy, Safety, and Immunogenicity of Biosimilar Etanercept (Enerceptan) Versus Its Original Form in Combination With Methotrexate in Patients With Rheumatoid Arthritis: A Randomized, Multicenter, Evaluator-Blinded, Noninferiority Study. J Clin Rheumatol. 2021 Sep 1;27(6S):S173-S179. doi: 10.1097/RHU.0000000000001616.
Other Identifiers
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GEMENE001
Identifier Type: -
Identifier Source: org_study_id