Clinical trial NCT03403140: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Gema Biotech S.A.
Sponsor class: INDUSTRY
Collaborators: name: QUID Quality in Drugs and Devices Latin American Consulting SRL
First posted: 2018-01-18
Enrollment: 141
Sex: ALL
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
timeFrame: 72 weeks
Secondary outcomes:
measure: Lab tests alterations [Safety and Tolerability]).
timeFrame: 72 weeks
measure: Local reactions [Safety and Tolerability]).
timeFrame: 72 weeks
measure: ACR20
timeFrame: 20 and 72 Weeks
measure: ACR50
timeFrame: 20 and 72 Weeks
measure: ACR70
timeFrame: 20 and 72 Weeks
measure: DAS (Disease activity state)
timeFrame: 20 and 72 Weeks
measure: Change in modified van der Heijde Sharp score
timeFrame: 20 and 72 Weeks
measure: Physical function
timeFrame: 20 and 72 Weeks
measure: Functional Assessment of Chronic Illness Therapy Fatigue scale (FACIT-Fatigue)
timeFrame: 20 and 72 Weeks
measure: Steady state concentration
timeFrame: 20 and 72 Weeks
measure: Immunogenicity
timeFrame: 20 and 72 Weeks
Other outcomes:
Locations:
city: Bs As
country: Argentina
facility: Instituto Medico CER
Study officials:
References: