The effect of Adalimumab on treatment of Rheumatoid Arthritis

Phase 3

• Conditions: M05.8, M06; Rheumatoid Arthritis.; Other seropositive rheumatoid arthritis ,Seronegative rheumatoid arthritis

• Registration Number: IRCT2015030321315N1
• Lead Sponsor: CinnaGen Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

Are male or female aged 18-75 years at the time of signing the informed consent form; Have been diagnosed as having active Rheumatoid Arthritis according to the EULAR criteria; moderately to severely active RA for at least 6 months; Patients who have inadequate response to the treatment with 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: liver Enzymes ALT or AST more than 2 Upper Limit Normal; Hemoglobin less than 8.5 mg/dL; Platelet count less than 125000 cell/mm3; WBC less than 3500 cell/mm3; Serum creatinine more than 2 mg/dL; Concomitant use of corticosteroids, prednisolone more than 10 mg/day or concomitant use of NSAIDS more than recommended dose of company; Treatment with intravenous, intramuscular, intra-articular and parenteral corticosteroids within 4 weeks prior to Day 1 more than 7.5 mg/daily ; Pregnancy, breasfeeding, or planning for being pregnant; History of CHF (Class III/IV) according to NYHA classification; demyelinating disorders, CHF; acute myocardial infarction or unstable angina within the previous 12 months prior to Screening, any malignancy within the previous 5 years prior to Screening, Any other disease or disorder which put the subject at risk if they are enrolled,, in the opinion of the Investigator, History of HIV, a positive serological test for HBV or HCV; Have a known hypersensitivity to human immunoglobulin proteins or other components of Humira or Adalimumab; Have been treated previously with any biological agents including any tumor necrosis factor inhibitor; 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 8 weeks or oral antibiotics within 2 weeks prior to screening; history of chronic or recurrent infection

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of efficacy Parameters of Adalimumab by AbbVie and Adalimumab by CinnaGen according to EULAR criteria. Timepoint: baseline, 3months and 6 months after intervention. Method of measurement: EULAR Criteria (The European League Against Rheumatism).

Secondary Outcome Measures

Name	Time	Method
Percentage of participants meeting ACR20 response criteria. Timepoint: baseline, 3months and 6 months after intervention. Method of measurement: ACR criteria (American College of Rheumatology).;Percentage of participants meeting ACR50 response criteria. Timepoint: baseline, 3months and 6 months after intervention. Method of measurement: ACR criteria (American College of Rheumatology).;Percentage of participants meeting ACR70 response criteria. Timepoint: baseline, 3months and 6 months after intervention. Method of measurement: ACR criteria (American College of Rheumatology).;Safety and frequency of AEs. Timepoint: every 2 weeks until 6 months. Method of measurement: in-house Questionnaire according to literature.;Concentration of the anti-drug antibodies. Timepoint: Prior to treatment and at months 3 and 6. Method of measurement: Validated Enzyme-Linked Immunosorbent Assay (ELISA).