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

NCT03403140 | Unknown Phase 3 DMC

• 1 other identifier: GEMENE002
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).

  Infections, hematological disorders,.neurologic disorders and malignancies .

  72 weeks

Secondary Outcomes (11)

• Lab tests alterations [Safety and Tolerability]).

  72 weeks

• Local reactions [Safety and Tolerability]).

  72 weeks

• ACR20

  20 and 72 Weeks

• ACR50

  20 and 72 Weeks

• ACR70

  20 and 72 Weeks

Study Arms (1)

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

Drug: Etanercept

Interventions

Etanercept DRUG

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

Single arm

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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 :
• 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.
• 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.

Sponsors & Collaborators

• Gema Biotech S.A.: lead
• QUID Quality in Drugs and Devices Latin American Consulting SRL: collaborator

Study Sites (1)

Instituto Medico CER

Bs As, Argentina

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: January 18, 2018
• Study Start: October 6, 2016
• Primary Completion: September 30, 2018
• Study Completion: October 31, 2018
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

AR (1)