This study compare the efficacy of Adalimumab by Asia Padtan and Humira in the treatment of rheumatoid arthritis. Disease activity is measured based on the disease activity score (DAS) of American College of Rheumatology. Twenty percent reduction in DAS will be considered as response to treatment . This study also determine and compare the drugs side effects and adverse events in both groups. One hundred and five patients with active rheumatoid arthritis will be enrolled to the study from rheumatology clinic of Shariati Hospital for six months. Patients are allocated to both groups based on balanced random block method. Main inclusion criteria are: age 18 years old or more, active rheumatoid arthritis and no history of treatment with Humira. Main exclusion criteria are impaired liver function tests and pancytopenia. Patients, clinicians and monitoring committee are all blind. All patients receive combination therapy of methotrexate and subcutaneous injection of adalimumab for a period of 16 weeks. The primary outcome variable is disease activity score (DAS) of rheumatoid arthritis. The side effects and adverse events caused by the intervention will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014090319025N1
Registration date:2015-09-24, 1394/07/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-24, 1394/07/02
Registrant information
Name
Mahdi Roohi
Name of organization / entity
MabAsia Biopharm
Country
Iran (Islamic Republic of)
Phone
+98 21885459612
Email address
h-faghihi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
MabAsia Company
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2017-05-23, 1396/03/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Adalimumab (MabAsia) versus Humira@ on activity score of Rheumatoid Arthritis: A Randomized Clinical Trial in refractory patients
Public title
Efficacy of MabAsia (Adalimumab) in Rheumatoid Arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:1-Age more 18 years old, 2- active Rheumatoid Arthritis, 3-not received Humira ® yet. exclusion criteria: 1-aminotransferase levels greater than twice the upper limit of normal and serum creatinine level more than 2mg/dL, a hemoglobin level of 8.5 mg/dL or less, platelet count less than 125000 cells/mm3, leukocyte count less than 3500 cells/mm3 3- Concomitant therapy with doses of oral corticosteroids greater than 10 mg of prednisone per day ,and NSAIDs with doses greater than the maximum dose recommended by the manufacturer
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences, Ethics Committee
Street address
Keshavarz, Blvd., Ghos St., Central Organization, 6th fl.
City
Tehran
Postal code
Approval date
2015-01-21, 1393/11/01
Ethics committee reference number
92-04-41-27276-13694
Health conditions studied
1
Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M05
ICD-10 code description
Seropositive Rheumatoid Arthritis
Primary outcomes
1
Description
Response to treatment for Rheumatoid Arthritis
Timepoint
Before beginning of treatment, after 3 months of treatment beginning, after 6 months of treatment beginning
Method of measurement
DAS 28 shows 20% improvement
Secondary outcomes
1
Description
side effects
Timepoint
Before intervention, After 3 months and after six months of therapy
Method of measurement
Clinically, by the rheumatologist, Cell Blood Count, Serum Biochemistry, Liver function test and Kidney function tests.