A Phase 3 interventional study of Etanercept in Rheumatoid Arthritis, sponsored by Gema Biotech S.A.. Status unknown at 1 site in Argentina. Open to participants aged 19 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-01-23.
Sponsored by Gema Biotech S.A. · Phase 3, Interventional, and Treatment
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
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.
Exclusion Criteria:
Administration of vaccines:
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.
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
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
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Infections, hematological disorders,.neurologic disorders and malignancies .
Time frame: 72 weeks
Lab tests alterations [Safety and Tolerability]).
Serum Hematological and chemistry values
Time frame: 72 weeks
Local reactions [Safety and Tolerability]).
Incidence, description and severity of Local Adverse Drug Reactions
Time frame: 72 weeks
ACR20
ACR (American College of Rheumatology) 20 The percentage of patients who achieved ACR20 at Week 32 is the primary end point. Signs and symptoms are assessed with a composite rating scale of the ACR (American College of Rheumatology) that includes 7 variables: * Tender Joints Count * Swollen Joints Count * Levels of an acute phase reactant (CRP level) * Patient's assessment of pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Patient's assessment of physical function
Time frame: 20 and 72 Weeks
ACR50
ACR50 is defined as the percentage of patients who achieve at least 50% improvement in both tender joint count and swollen joint count, and at least 50% improvement in at least 3 of the 5 other assessments.
Time frame: 20 and 72 Weeks
ACR70
ACR70 is defined as the percentage of patients who achieve at least 70% improvement in both tender joint count and swollen joint count, and at least 50% improvement in at least 3 of the 5 other assessments.
Time frame: 20 and 72 Weeks
DAS (Disease activity state)
It will be measured using the DAS (Disease activity state) 28. DAS28 is a composite score that includes 4 variables: * Tender Joints Count (based on 28 joints) * Swollen Joints Count (based on 28 joints) * Patient's global assessment of disease activity * Marker of inflammation: C REACTIVE PROTEIN
Time frame: 20 and 72 Weeks
Change in modified van der Heijde Sharp score
The Sharp method is a composite X-ray scoring system used to assess structural (joint) disease progression in rheumatoid arthritis. The method evaluates both joint erosions (JE) and joint space narrowing (JSN) in bilateral hand and foot joints. The Sharp/van der Heijde method assesses erosions and joint space narrowing separately in the hands and feet, and has a range from 0 to 448. Thirty-two joints in the hands and 12 in the feet are scored for erosions, with a maximum score of five per joint in the hands and 10 per joint in the feet. Joint space narrowing is graded from 0 to 4 in 30 joints in the hands and in 12 joints in the feet. The principal score used in the analyses is the total score, which is the sum of the erosion score and the joint space narrowing score.
Time frame: 20 and 72 Weeks
Physical function
Improvement in physical function is assessed by change from baseline in HAQ (Health Assessment Questionnaire).The HAQ-DI (disability index) is composed of 8 categories as follows: dressing and grooming, arising, eating, walking, hygiene, reach, grip and activities, for which there are at least 2 questions by category. The patient will be asked to score how difficult he/she feels it is to perform such activities using a 0 to 3 scoring (0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do). If the patient is using assistance for any of these activities, scoring may be adjusted. For each category, the highest score given for one of the question is attributed to the category. The total score is the sum of all categories' scores divided by the number of answered categories (at least 3 categories should be answered)
Time frame: 20 and 72 Weeks
Functional Assessment of Chronic Illness Therapy Fatigue scale (FACIT-Fatigue)
The FACIT-Fatigue is a 13-item questionnaire rated 0 to 4. The patient will be asked to answer to 13 questions rated 0 to 4 (0=not at all, 1=a little bit, 2=some what, 3=quite a bit, 4=very much
Time frame: 20 and 72 Weeks
Steady state concentration
Etanercept concentration measure
Time frame: 20 and 72 Weeks
Immunogenicity
Antibodies anti-Etanercept measure
Time frame: 20 and 72 Weeks
Plan to share: Undecided
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Gema Biotech S.A.