RHEUMATOID ARTHRITIS MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Interventions
Trade Name: Etanercept
Pharmaceutical Form: Injection*
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Sponsors
Wyeth Pharmaceuticals France
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1- 18 years of age or older at time of consent. 2- Meet the 1987 ACR Revised Criteria for Rheumatoid Arthritis. 3- Active Rheumatoid Arthritis: evidence of clinical signs of joint inflammation / swelling at screening and randomization. 4- Documented evidence, confirmed by a blinded 3rd party assessor, of at least one erosion observed by X-ray (hands or feet) at randomization based on X-ray taken at the screening visit. Subjects with no confirmed erosion at the randomization visit are to be withdrawn. 5- Plasma C-reactive protein level of at least 8.0 mg/L or Erythrocyte Sedimentation Rate of at least 28 mm/h in sample taken at the screening visit. 6- Currently receiving optimized* treatment with MTX but with active disease as defined by a DAS28 score of >3.20 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previous treatment with ETN, infliximab, adalimumab, other TNF-a inhibitors, anakinra or other biological agents. Receipt of any DMARD, other than MTX, within 28 days before screening. Unable to tolerate MTX at a minimum dose of 12.5 mg/week orally, intramuscularly or SC. Known significant (in the opinion of the investigator) concurrent medical disease including:· Uncompensated congestive heart failure, or class III or IV heart failure defined by the New York Heart Association classification. History of or current pancytopenia or aplastic anemia. Diagnosis of multiple sclerosis or other central or peripheral nervous system demyelinating diseases. Current malignancy or an individual history of cancer (other than resected basal cell carcinoma of the skin) within five years of the screening visit. Active infection including known human immunodeficiency virus (HIV) infection and tuberculosis (TB). (Note: follow local country guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF therapy) Sepsis, or at risk of sepsis. Subjects with signs of immunodeficiency. Other current autoimmune connective tissue diseases such as diagnosis of systemic lupus erythematosus, scleroderma, or polymyositis. Significant renal disease in the investigator’s opinion. Abnormal hematology or chemistry profiles: · white blood cell (WBC) count =175 mmol/L · Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level =>2 times the laboratory’s upper limit of normal · Clinically significant abnormal screening laboratory values in the investigator’s opinion (based on country-specific standard of care) Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception. Use of any investigational treatment or device within 3 months (or 5 half lives of the treatment, whichever is longer) of the screening visit. Concomitant oral corticosteroid >10 mg/day of prednisone or its equivalent at the point of screening (corticosteroid dose must be stable for at least four weeks prior to screening). Intra-articular, intravenous, intramuscular or subcutaneous (SC) corticosteroid injection within 28 days of the screening visit. Active alcoholism and/or substance abuse within one year of the screening visit. Conditions requiring initiation of new drug therapy concurrent with entry into this study. Receipt of any live viral or bacterial vaccines (attenuated vaccines) within 28 days prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the impact of ETN + MTX in comparison with usual treatment on radiographic disease progression at 52 weeks in subjects with moderate RA who failed treatment with MTX.;Secondary Objective: To compare the effects of ETN + MTX and usual treatment on clinical outcomes. To compare the effects of ETN + MTX and usual treatment on health-related quality of life and dimensions of impact of disease on subjects over 52 weeks. To evaluate the safety of the treatment regimen over 52 weeks.;Primary end point(s): The primary endpoint for this study is the change from randomization in modified TSS at 52 weeks. | — |
Countries
Austria, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Poland, Spain, United Kingdom
Outcome results
None listed