NCT03403140Unknown3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 :
- •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.
- •Past history of drug or alcohol abuse within the study GEMENE
- •Any condition that, in the investigator's opinion, would not allow compliance with the guidelines of the study by the patient.
研究组 & 干预措施
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
干预措施: Etanercept (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
时间窗: 72 weeks
Infections, hematological disorders,.neurologic disorders and malignancies .
次要结局
- 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)
- DAS (Disease activity state)(20 and 72 Weeks)
- Change in modified van der Heijde Sharp score(20 and 72 Weeks)
- Physical function(20 and 72 Weeks)
- Functional Assessment of Chronic Illness Therapy Fatigue scale (FACIT-Fatigue)(20 and 72 Weeks)
- Steady state concentration(20 and 72 Weeks)
- Immunogenicity(20 and 72 Weeks)
研究者
研究点 (1)
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