A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis
- Conditions
- Rheumatoid ArthritisTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2013-004569-16-DE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
1.Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
2.Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3.Subject is literate and able to complete the protocol-specified questionnaires.
4.Either the subject or a designee must be capable (according to the investigator’s judgment) of administering the SC investigational product and must be able to store all investigational product under required storage conditions or must be able to come to the study site for administrations where the investigational product may be stored on behalf of the subject.
5.Male and female =18 years of age at the time of consent.
6.Male and female subjects who are of childbearing potential must agree to use a highly effective method of contraception throughout the study and for atleast 30 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
• Female subjects mus tmeet at least one of the following criteria to be considered not of childbearing potential:
• Have undergone a documented hysterectomy and/or bilateral oophorectomy;
•Have medically confirmed ovarian failure or;
•Achieved post-menopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormonelevel within the laboratory’s reference range for postmenopausal females.
7.Female subjects of childbearing potential must have negative urine pregnancy test results based on the screening visit and baseline visit tests. This includes subjects who are menstruating at the time of the visit and/or who are not sexually active.
8.Meets the 2010 ACR criteria for RA(see Appendix 1).
9.Active disease as defined as DAS28 =3.2 and presence of atleast 4 tender joints and 4 swollen joints at screening and baseline visits.
10.Screening laboratory results must demonstrate:
•Aspartate aminotrasferase / alanine aminotrasferase (AST, ALT) <2times the upper limit of normal;
•Hemoglobin >8.5g/dL;
•Platelet count >125,000/cmm;
•White blood cell (WBC) count >3500cells/cmm;
•Serum creatinine =2mg/dL.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90
1.Received any previous treatment with ETN.
2.Received MTX dose greater than 25 mg/week, or change in dose or route within 6 weeks of first dose of investigational product.
3.Dose change inpermitted nonbiological DMARDs within 4 weeks of first dose of investigational product.
4.Received cyclophosphamide, cyclosporine, or azathioprine within 6 months of the first dose of investigational product.
5.Received TNF antagonist (eg,a TNF monoclonal antibody or a soluble TNF-receptor) or any other biologic treatment for RA within 12 weeks of first dose of investigational product.
6.Received any biologic B-cell depleting agent (eg,rituximab) within 2 years of first dose of investigational product.
7.Received intra-articular (IA); soft tissue; or bolus intramuscular (IM) orintravenous (IV) treatment with corticosteroids within 4 weeks of first dose of investigational product.
8.Received oral corticosteroids >10 mg/day of prednisone (or equivalent), or change in dose within 2 weeks of first dose of investigational product.
9.Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) greater than the maximum recommended dose per local label.
10.Received any live (attenuated) vaccines within 4 weeks before the first dose of investigational product.
11.Serious infection (infection associated with hospitalization and/or parental (IV or IM) anti-infective agents) within 4 weeks before first dose of investigational product.
12.Active infection at the time of the screening visit and /or baseline visit. Certain minor active infections (ie,vaginitis, tinea, etc) could be allowed on a case-by-case basis only after approval from the study physician clinician.
13.Active tuberculosis (TB), or evidence of untreated latent or active TB:
a.Local country guidelines should be followed for appropriate TB screening and prophylaxis in the setting of anti-TNF therapy, including a minimum of:
•A chest radiograph, to be performed at the screening visit and read locally by a qualified reader unless a chest radiograph has been done within 12 weeks before the screening visit and the report is available and included in the subject’s source documents. If required by local regulations, a chest x-ray taken within 6 months of the screening visit may be used as long as the report is available and included in the subject’s source documents;
•Objective TB testing, such as QuantiFERON® or purified protein derivative (PPD) depending on what is available and acceptable per local guidelines. Testing requirements in Section 6.1 Screening Procedure #9 Chest radiograph and TB testing:must be adhered to.
b.Active TB:
•Subjects with current or recent (within 2 years before the screening visit) active TB infection are excluded.
•Subjects with a history of active TB more than 2 years before the screening visit and with documentation of completing an adequate regimen of anti-TB therapy may be considered for enrollment after discussion with the sponsor’s Clinical team.
c.Latent TB:
•Subjects with evidence of latent TB infection may be allowed only if local guidelines are followed for prophylactic therapy and if TB chemoprophylaxis has been either adequately completed per local guidelines or initiated at least 4 weeks before the baseline visit. The screening period may be extended to 6 weeks when TB prophylactic treatment is necessary. Subjects who have not completed chemoprophylaxis per local guidelines at the time of the screening visit must agree to continue to co
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method