Study to Demonstrate Non-Inferior Efficacy and Safety of CinnoRA® Versus Humira® for Treatment of Active RA
Active Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Active Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Male or female aged 18-75 years at the time of signing the informed consent form.
- Have been diagnosed as having active rheumatoid arthritis (RA) according to The European League Against Rheumatism criteria
- moderately to severely active RA for at least six months
- Patients who have an inadequate response to the treatment with the usual non-biological regimen for at least 12 weeks according to their investigator judgment.
- Ability to comprehend and willingness to sign the Informed Consent Form for this study.
Exclusion Criteria:
- Tuberculosis patient or latent tuberculosis patient (PPD >5mm or abnormal Chest X-ray)
- Have been treated previously with any biological agents including any tumor necrosis factor inhibitors (including ORENCIA® (abatacept), KINERET® (anakinra), REMICADE® (infliximab), ENBREL® (etanercept), CIMZIA® (certolizumab pegol), SIMPONI® (golimumab), or Adalimumab).
- Have a known hypersensitivity to human immunoglobulin proteins or other components of Humira or test- Adalimumab
- Women who are pregnant, breastfeeding or planning to become pregnant during the study
- Have a positive serological test for hepatitis B or hepatitis C or have a known history of infection with human immunodeficiency virus (HIV) of the past three months.
- Physical incapacitation (ACR functional Class IV or wheelchair-/bed-bound)
- Have had a serious infection or have been treated with intravenous antibiotics for an infection within eight weeks or oral antibiotics within two weeks prior to screening
- Have a history of chronic or recurrent infection
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > two times upper limit of normal.
- Hemoglobin <8.5 g/dL.
- Platelets <125,000/µL.
- Leukocyte count <3500/µL.
- Serum Creatinine>2 mg/dl
- Concomitant use of Prednisolone > 10 mg/day and NSAIDs
- Treatment with intravenous, intramuscular, intra-articular and oral corticosteroids within four weeks prior to Day 1 (prednisolone, more than 7.5 mg/daily)
- Ever used RITUXAN® (rituximab), IMURAN® (azathioprine), or PURINETHOL® (mercaptopurine, 6-MP).
Have any of the following conditions:
- History of congestive heart failure.
- History of acute myocardial infarction or unstable angina within the previous 12 months prior to Screening.
- History of demyelinating disorders (e.g., MS)
- History of multiple sclerosis
- History of any malignancy within the previous five years prior to Screening.
- Any other disease or disorder which, in the opinion of the Investigator, will put the subject at risk if they are enrolled.
Sites / Locations
- Alzahra Hospital
- Besat 4 Clinic
- Ghaem Hospital
- Razi Hospital
- Imam Ali Clinic
- Hafez Hospital
- Noor Medical Complex
- Imam Reza Hospital (501 Artesh)
- Iran Rheumatism Center
- Loghman Hakim Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
CinnaGen adalimumab
AbbVie adalimumab
CinnoRA® (adalimumab Prefilled Syringe produced by CinnaGen Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.
Humira® (adalimumab Prefilled Syringe produced by AbbVie Company) 40 mg/0.8 ml Every other week 40 mg Adalimumab, will be subcutaneously administered to rheumatic patients during six months. Along with, 15 mg weekly methotrexate, at least 1 mg daily Folic acid and 7.5 mg daily Prednisolone over six months.