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

Gema Biotech

Status and phase: Unknown; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Etanercept

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03403140

GEMENE002

Details and patient eligibility

About

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

Full 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.

Enrollment: 141 estimated patients

Sex: All

Ages: 19 to 99 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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141 participants in 1 patient group

Single arm

Experimental group

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

Treatment:

Drug: Etanercept