A Phase III, randomized, two-armed, double-blind (patient and assessor blinded), parallel active controlled non-Inferiority clinical trial to determine the non-inferior therapeutic efficacy and safety of two disease-modifying anti rheumatic drugs (CinnoRA ) versus Humira® for treatment of Active rheumatoid arthritis
The purpose of this study is to compare the efficacy of adalimumab produced by CinnaGen company and AbbVie adalimumab in subjects with active Rheumatoid Arthritis. Patients with diagnosis of active Rheumatoid arthritis according to EULAR criteria (European League Against Rheumatism) aged between 18 to 75 years will be included. Those with certain medical conditions like history of Multiple Sclerosis or Hepatitis C, Hepatitis B, HIV along with concomitant use of corticosteroids more than 10 mg/day prednisolone, will be excluded
This is a randomized, double blind clinical trial in which adalimumab is administered subcutaneously 40 mg every other week in addition to current anti-rheumatic therapies for 136 eligible patients over six months. Changes from baseline in disease activity according to EULAR criteria and ACR (ACR20, ACR50, ACR70 will be assessed at 12 weeks and 24 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030321315N1
Registration date:2015-04-05, 1394/01/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-04-05, 1394/01/16
Registrant information
Name
Nassim Anjidani
Name of organization / entity
Orchid Pharmed
Country
Iran (Islamic Republic of)
Phone
+98 21 4347 3000
Email address
amini@orchidpharmed.com
Recruitment status
Recruitment complete
Funding source
CinnaGen Company
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Phase III, randomized, two-armed, double-blind (patient and assessor blinded), parallel active controlled non-Inferiority clinical trial to determine the non-inferior therapeutic efficacy and safety of two disease-modifying anti rheumatic drugs (CinnoRA ) versus Humira® for treatment of Active rheumatoid arthritis
Public title
The effect of Adalimumab on treatment of Rheumatoid Arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
136
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran University of Medical Sciences
Street address
Sixth floor, Research Deputy of Tehran University of Medical Sciences, Ghods Street, Keshavarz Boulvard
City
Tehran
Postal code
Approval date
2014-12-06, 1393/09/15
Ethics committee reference number
26826
2
Ethics committee
Name of ethics committee
Research Ethics Committee of Kerman University of Medical Sciences
Street address
Ebn-e-Sina Ave, Jahad Blvd, Tehmaseb Abad Cross, Kerman., Iran
City
Kerman
Postal code
Approval date
2015-07-13, 1394/04/22
Ethics committee reference number
IR.KMU.REC.1394.126
Health conditions studied
1
Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M05.8, M06
ICD-10 code description
Other seropositive rheumatoid arthritis ,Seronegative rheumatoid arthritis
Primary outcomes
1
Description
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 outcomes
1
Description
percentage of participants meeting ACR20 response criteria
Timepoint
baseline, 3months and 6 months after intervention
Method of measurement
ACR criteria (American College of Rheumatology)
2
Description
percentage of participants meeting ACR50 response criteria
Timepoint
baseline, 3months and 6 months after intervention
Method of measurement
ACR criteria (American College of Rheumatology)
3
Description
percentage of participants meeting ACR70 response criteria