Efficacy of MabAsia (Adalimumab) in Rheumatoid Arthritis

Efficacy of Adalimumab (MabAsia) versus Humira@ on activity score of Rheumatoid Arthritis: A Randomized Clinical Trial in refractory patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014090319025N1

Enrollment

105

Registered

2015-09-24

Start date

2015-09-23

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis. Seropositive Rheumatoid Arthritis

Interventions

Intervention 1: Drugs in intervention group: 1-Humira 40 mg every other week subcutaneously (2 pre-filled syringes 40 mg/0.8ml) 2-oral Methotrexate (MTX) 15 mg/week 3-Tablet prednisolone 10 mg/d

Treatment - Drugs

Drugs in intervention group: 1-Humira 40 mg every other week subcutaneously (2 pre-filled syringes 40 mg/0.8ml) 2-oral Methotrexate (MTX) 15 mg/week 3-Tablet prednisolone 10 mg/d 4-Tablet Ca

Drugs in control group: 1-Adalimumab (MabAsia) 40 mg every other week ,subcutaneously (2 pre-filled syringes 40 mg/0.8ml) 2-oral methotrexate (MTX) 15 mg/week 3-Tablet prednisolone 10 mg/d 4-Ta

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehdi Roohi

MabAsia Biopharm

maroohi@gmail.com+98 21885459612

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026