A clinical trial to study the effects of Zenotechs Etanercept 50 mg injection in comparison with Wyeth?s Enbrel® injection in patients with moderate to severe rheumatoid arthritis with inadequate response to methotrexate
- Conditions
- Health Condition 1: null- MODERATE TO SEVERE RHEUMATOID ARTHRITIS
- Registration Number
- CTRI/2011/05/001724
- Lead Sponsor
- Zenotech Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 110
1.Subjects of either sex, equal and greater than 18 years of age
2. Subjects fulfilling American Rheumatism Association 1987 criteria for Rheumatoid Arthritis (Appendix I).
3. Subjects who have disease activity classified as moderate to severe i.e., equal and greater than 6 tender and equal and greater than 6 swollen joints out of 28 joints included in American College of Rheumatology (ACR) criteria and Disease Activity Score (DAS) 28 [i.e., bilateral shoulder (2), elbow (2), wrist (2), metacarpohalangeal (10), proximal interphalangeal (10) and knee (2) joints] with Erythrocytes Sedimentation Rate (ESR) equal and greater than 28 mm/hr.
4. Subjects who have shown inadequate response after receiving methotrexate for at least 3 months with a stable dose (12.5 mg to 25 mg) for at least 4 weeks.
5. Subjects with Global Functional Status Assessment - class I, II or III according to the revised criteria of the American College of Rheumatologists (ACR) [Appendix VI].
6.Subjects who have taken other non biologic Disease modifying anti-rheumatic drugs (DMARDs) such as sulfasalazine, and hydroxychloroquine (except methotrexate) should discontinue their use 4 weeks prior to investigational product administration in this study.
For male subjects only
7. Sexually active male subjects who agree to use a medically accepted form of contraception during the study or the partner using an acceptable form of contraception.
1. Subjects with hypersensitivity to etanercept or any other component of the product. Subjects allergic to latex shall be excluded (the needle cap on the etanercept prefilled syringe contains latex which may cause allergic reactions in individuals sensitive to latex).
2. Subjects unwilling or unable to give informed consent and who are unable or unwilling to comply with the study procedures.
3. Pregnant or breast-feeding women or women with positive urine pregnancy test at screening or women with reproductive potential unwilling to use a medically acceptable form of contraception.
4. Subjects with history of tuberculosis in the past or having findings suggestive of active tuberculosis or latent tuberculosis.
5. Subjects with history of immunodeficiency diseases, including HIV infection
6. Subjects with positive serological tests for hepatitis B surface antigen or hepatitis C antibody (or a known diagnosis of hepatitis B or hepatitis C).
7. Subjects with SGOT/AST, SGPT/ALT, Alkaline Phosphatase, or Bilirubin 2.0 times Upper Limit of normal (ULN) or serum creatinine ¡Ý 1.2 times ULN.
8. Subjects who have participated in any investigational study within the last 3 months prior to entry in this study.
9. Subjects with clinically significant renal, hepatic, cardiovascular [including New York Heart Association (NYHA) grade III or IV], hematologic, endocrine, pulmonary (including pulmonary fibrosis), gastrointestinal, urogenital, neurological (including demylenating disorders) and psychiatric illness.
10. Subjects with any other clinically significant concurrent illness, which in the opinion of the investigator may jeopardize the safety of the subject during the study or may interfere with the evaluation of efficacy of the study medication.
11. Subjects with active infections, including chronic or localized infections.
12. Subjects with history of septic arthritis of a native joint within the last 12 months or history of septic arthritis of a prosthetic joint at any time.
13. Subjects with history of alcohol or drug abuse.
14. Subject who have received any live (attenuated) vaccines within 4 weeks of screening assessment.
15. Subject has received any biologic Disease Modifying Anti Rheumatic Drug (such as etanercept, infliximab, abatacept, anakinra) in the past.
16. Subjects with platelet counts 125,000 per cubic mm or TLC 3500 per cubic mm.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method