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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03403140
• Date of registration: 30/11/2017
• Prospective Registration: No
• Primary sponsor: Gema Biotech S.A.
• Public title: Long Term Efficacy, Safety and Immunogenicity of Enerceptan in Rheumatoid Arthritis ( GEMENE002 )
• Scientific 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
• Date of first enrolment: October 6, 2016
• Target sample size: 141
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03403140
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina

Key inclusion & exclusion 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.



Age minimum: 19 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Etanercept

Primary Outcome(s)

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). [Time Frame: 72 weeks]

Secondary Outcome(s)

ACR20 [Time Frame: 20 and 72 Weeks]

Change in modified van der Heijde Sharp score [Time Frame: 20 and 72 Weeks]

Functional Assessment of Chronic Illness Therapy Fatigue scale (FACIT-Fatigue) [Time Frame: 20 and 72 Weeks]

ACR50 [Time Frame: 20 and 72 Weeks]

DAS (Disease activity state) [Time Frame: 20 and 72 Weeks]

Immunogenicity [Time Frame: 20 and 72 Weeks]

Lab tests alterations [Safety and Tolerability]). [Time Frame: 72 weeks]

ACR70 [Time Frame: 20 and 72 Weeks]

Physical function [Time Frame: 20 and 72 Weeks]

Local reactions [Safety and Tolerability]). [Time Frame: 72 weeks]

Steady state concentration [Time Frame: 20 and 72 Weeks]

Secondary ID(s)

GEMENE002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

QUID Quality in Drugs and Devices Latin American Consulting SRL